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Indian Standard
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22870 : 201 )
I
17723 :
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Medical Laboratories Requ irements for Quality and
Competence
( Third Revision)
ICS 03.120.10,11 .100.01
© SIS 2023
© ISO 2022
BUREAU OF INDIAN STANDARDS
11RCfi 'lic:H, 9 ~b ~~~l1rf, ~~- 110002
'-.)
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI - 110002
www.bis.gov.in
March 2023
www.standardsbis.in
Price Group 15
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Hospital Pl anning Sectional Committee , MHO 14
NATIONAL FOREWORD
f his Indian Standard (Third Revision) which is an identical adoption of ISO 15189 : 2022 'Medical
La boratori es - Requirements for Quality and Competence' issued by the International Organization for
Standardization (ISO) , was adopted by the Bureau of Indian Standards on the recommendation of the
HospitC!I PIC!nning SectionCII Committee ~mel qpprovC!I of the MeclicC!I l:;quipment C!n<:l Hospital Plannin~
Divi sion ...,ouncil.
1his sta ndard was first published in 2005 based on ISO 15189 : 2003 and was subsequently revised in
201 0 and 2014 to align its requirements with ISO 15189: 2007 and ISO 15189: 2012 respectively. This
revision has been undertaken to align with ISO 15189 : 2022.
1his stand ard also gives the requirements for quality and competence for point-of-care testing (POCT) ,
which were earlier given in ISO 22870: 2016 . With the publication of this standard, IS 17723 : 2021 'Pointof-care testing (POCT) Requirements for quality and competence' which was an identical adoption of ISO
22870 : 2016 stands withdrawn.
lhe text of ISO Standard has been approved as suitable for publication as an Indian Standard
without deviations. Certain terminologies and conventions are, however, not identical to those used in
Indian Standards. Attention is particularly drawn to the following :
a)
b)
Wherever the words 'International Standard' appear referring to this standard, they should be
read as 'Indian Standard '.
Comma (,)has been used as a decimal marker, while in Indian Standards, the current practice
is to use a point (.) as the decimal marker.
In this aclopteq stE~ndC!rd , reference ~ppe~rs to cert~in lnternC!tionC11 Stande1rds for which ln<:licm Standards
F-11 ~1'1 ~x i ~t. Th ~ Gmr~I'! RnnrHno lnrfirm Rtnnrfnnifi. whiGh nr~ tn ~m l'il1hl'ltiM~n in t h ~ir p lace~ . are listeq
below along with their degree of equivalence for the editions indicated:
International Standard
Corresponding Indian Standard
Degree of Equivalence
ISOIIEC
17000
2020
Conformity
assessment
Vocabulary
and
general
principles
IS/ISO/IEC
17000
2020
Conformity
Assessment
Vocabulary
and
general
principles (first revision)
Identical
ISO/IEC 17025 : 2017 General
requirements for the competence
of
testing
and
calibration
laboratories
IS/ISO/IEC
17025
2017
General requirements for the
competence of testing and
calibration laboratories (second
revision)
Identical
(Continued on third cover')
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Contents
In t t·o d u ct i on ......................................................................................................................................................................................................... .................... vi
1
Scope ................................................................................................................................................................................................................................. l
3
..................................................................................................................................................................................... 1
3
Ter 1ns a nd de finitions ....................................... ,............................................................................................. ..
4
Genera I r eq tt i remPn t ............................................................................................................................................................... ..................... U
I tnprt l'"ti n1it)' ......................u••••• · ~··~~·~~··~~·· ·•· u •u•• • ••· · ~" ······· ·· · ··· ·· ·· · ····· .. ········· ............................................................................................... 8
4.2
Co n fident ia lity ........................................................................................................................................................................................ 8
4.2.1 Ma nagement f inforn tation ................................................................................................................ ..................... 8
4.2.2 Release of informat ion ............................................................................................................................. ..................... 9
4.2.3 Personnel respo ns ibili ty .............................................................................................................................................
4.3
Requirem ents regardi ng p ti nt ......................................................................................................................................... 9
............................ 1
4·. I
5
Structural and governance r equire ments ................................................................................................................................ 9
Legal entity ........................................................................................................................................................................... .................... .
5.1
5.2
Laboratory director ........................................................................................................................................................................ ) 0
5.2.1 Laboratory directo r co mp etenc e ..................................................................................................... ................. 10
5.2.2 Laboratory di recto r r esponsibilities ............................................................................................................. lO
5.2.3 Delegation of duti es ...................................................................................................................................................... 10
5.3
Laboratory activiti es ............................................................... :...................................................................................................... lO
5.3.1 General ..................................................................................................................................................................................... 10
5.3.2 Conformance wi th requi rements .................................................................................................... ................. 10
5.3.3 Advisory activiti es ......................................................................................................................................................... 10
5.4
Structure and authority .............................................................................................................................................................. 11
5.4.1 General .................................................................................................................................................................... ................. 11
5.4.2 Quality man agement. .................................................................................................................................. ................. 11
Objectives and policies ................................................................................................................................................................. 11
5.5
!j,6
Ri,1,k ttld l td get tll::! l ll.. ............................................................................................................................................................................ 12
6
Resource requirements .............................................................................................................................................................................1 2
6.1
General ....................................................................................................................................................................................... ................. 12
6.2
Personnel .................................................................................................................................................................................................. 12
6.2.1 General ..................................................................................................................................................................................... 12
6.2.2 Competence require1nents ..................................................................................................................................... 12
6.2.3 Authorization ..................................................................................................................................................................... 13
6.2.4 Continuing education and professional development... ................................................................. 13
6.2.5 Personnel records ........................................................................................................................................................... 13
Facilities and environmental conditions ...................................................................................................................... 13 ·
6.3
6.3.1 General ..................................................................................................................................................................................... 13
6.3.2 Facility controls ................................................................................................................................................................ 14
6.3-.3 Storage facilities .............................................................................................................................................................. 14
6.3.4 Personnel facilities ........................................................................................................................................................ 14
6.3.5 Sample collection facilities ..................................................................................................................................... 14
6.4
Equipment. ............................................................................................................................................................................................... 15
6.4.1 General ..................................................................................................................................................................................... 15
6.4.2 Equipment requirements ......................................................................................................................................... 15
6.4.3 Equipment acceptance procedure ................................................................................................................... 15
6.4.4 Equipment instructions for use ......................................................................................................................... 15
6.4.5 Equipment maintenance and repair .............................................................................................................. 15
6.4.6 Equipment adverse incident reporting........................................................................................................ 16
6.4.7 Equipment records ........................................................................................................................................................ 16
Equipment calibration and metrological traceability ...................................................................................... 17
6.5
6. 5.1 General ..................................................................................................................................................................................... 17
6.5.2 Equipment calibration ................................................................................................................................................ 17
iii
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6.6
6.7
6.5.3 Metrological traceability of meas urement results ........................................................................... 17
Reagents and consumables ...................................................................................................................................................... 18
6.6.1 Genera1..................................................................................................................................................................................... 18
6.6.2 Reagents and cons umables- Receipt and storage ......................................................................... 18
6.6.3 Reagents and consumables - Acc eptance testing ........................................................................... 18
6.6.4 Reagents and consumables- Inventory management.. .............................................................. 18
6.6.5 Reagents and consumables -Instructions for use ......................................................................... 19
6.6.6 Reagents and consumables- Adverse incident reporting ...................................................... 19
6.6.7 Reagents a nd consum ables - Record s ...................................................................................................... 19
Service agreements ......................................................................................................................................................................... 19
6.7.1
Agreements with laboratory users ................................................................................................................. 19
fl ~ 712
AerP.F.m Ants wlth PO~T nnF.r(l
19
Externally provided products and se rvi ces .............................................................................................................. 20
6.8.1 General ..................................................................................................................................................................................... 20
6.8.2 Referral laboratories and consultants ......................................................................................................... 20
6.8.3 Review and approval of externally provided products and services ............................... 20
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6.8
7
Process requirements ................................................................................................................................................................................. 21
7.1
General ..............................................................:......................................................................................................................................... 21
7.2
Pre-examination processes ...................................................................................................................................................... 21
7.2.1 General ......................................................................................................................................................... ,........................... 21
7.2.2 Laboratory information for patients and users ........................................................~.......................... 21
7.2.3 Requests for providing laboratory examinations .............................................................................. 21
7.2.4 Primary sample collection and handling ................................................................................................... 22
7.2.5 Sample transportation ............................................................................................................................................... 23
7.2.6 Sample receipt ................................................................................................................................................................... 24
7.2.7 Pre-examination handling, preparation, and storage .................................................................... 24
7.3
Examination processes ................................................................................................................................................................ 25
7.3.1
General ..................................................................................................................................................................................... 25
7.3.2 Verification of examination methods ............................................................................................................ 25
7.3.3 Validation of examination methods ............................................................................................................... 25
7.3.4 Evaluation of measurement uncertainty (MU) .................................................................................... 26
7.3.5 Biological reference intervals and clinical decision limits ........................................................ 26
7.3.6 Documentation of examination procedures ........................................................................................... 27
7.3.7 Et1.t:: Urltig tli~ V~lltllty UI' ~;<,arrtlrt::illlltl t'~.t::Ull.t:: ........................................................................................ :L7
7.4
Post-examination processes .................................................................................................................................................... 30
7.4.1
Reporting of results ...................................................................................................................................................... 3D
7.4.2 Post-examination handling of samples ....................................................................................................... 32
7.5
Nonconforming work ..................................................................................................................................................................... 33
7.6
Control of data and information management.. ...................................................................................................... 33
7.6.1
General ..................................................................................................................................................................................... 33
7.6.2 Authorities and responsibilities for information management.. ........................................... 33
7.6.3 Information systems management ................................................................................................................. 34
7.6.4 Downtime plans ............................................................................................................................................................... 34
7.6.5 Off site management .................................................................................................................................................... 34
7.7
Complaints ............................................................................................................................................................................................... 34
7.7.1
Process ..................................................................................................................................................................................... 34
7.7.2
Receipt of complaint. .................................................................................................................................................... 35
7.7.3
Resolution of complaint. ............................................................................................................................................ 35
7.8
Continuity and emergency preparedness planning ........................................................................................... 35
8
Management system requirements .............................................................................................................................................. 35
8.1
General requirements ................................................................................................................................................................... 35
8.1.1 General ..................................................................................................................................................................................... 35
8.1.2 Fulfilment of management system requirements ............................................................................. 3 6
8.1.3 Management system awareness ........................................................................................................................ 36
8.2
Management system documentation .............................................................................................................................. 36
8.2.1 General ..................................................................................................................................................................................... 36
8.2.2 Competence and quality ........................................................................................................................................... 36
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8.3
8.4
8.5
8.6
8.7
8.8
8.9
8.2 .3 Evid n Cf' of I ' !lin 111 it 111 •nt .......................................................................................................................................... :J(,
8.2.4 Do <.: tlln •n t :1t i<lll .................................................................................................................................................................. :lrJ
8. 2.5 P rstln n •I ai 'I ' ('S. · .......................................... ........ ........................................................................................... ................. :l 6
Control of ln a nar,•<.,' ntt'tll ,·ysl m doc t1m ents ............................................................................................. ................. ?l7
8.3.1 Gen ral ................................................................................................................................................................... _................. :1'/
8.3.2 Control of dot-11111 'IllS ................................................................................................................................ -................. : 7
Control of reco1·ds ............................................................................................................................................................ ................. :;7
8.4.1 Creation of r ·c.:ords ........................................................................................................................................................ ::l7
8.4.2 Am endm nltlf'r• ·u rd s ............................................................................................................................. .................. 7
8.4. 3 Reterl tlot t of 1· ·un.ls .....................................................................................................................................................::l!:l
Actions to ddress ri sks a nd opporlunili s for improv m nt................................................. ................. :1fl
8.5.1 ld ent ificalio n of ri sks and opportuniti s for improven 1•nt. ..................................................... :1 B
8.5.2 Acting on risks ;;rn d oppo r tuniti s for improv 11J enl ...................................................................... 38
Irnprovement ........................................................................................................................................................................ ................. 9
8.6.1 Continu al improv ' ment.. ........................................................................................................................................... 39
8.6.2 Laboratory patients, user, and personn el feedbac k......................................................................... ::li:J
Nonconformities and co rrective actions ...................................................................................................................... 3
8.7.1 Actions wh en nonconformity occurs............................................................................................................ 9
8.7.2
Corrective ct ion effectiveness ......................................................................................................... ................. 40
8. 7.3 Records of noncon formities and correct ive actions ........................................................................ 40
Evaluations .............................................................................................................................................................................:...............40
8. 8.1 Genera 1.................................................................................................................................................................... ................. 40
8.8.2 Quality indicators ........................................................................................................................................................... 40
8.8.3 Internal audits ................................................................................................................................................................... 40
Managernent reviews ..................................................................................................................................................................... 41
8.9.1
General .................................................................................................................................................................... ................. 41
8.9.2 Review input ....................................................................................................................................................................... 41
8.9.3 Review output .................................................................................................................................................................... 41
Annex A (normative) Additional requirements for Point-of-Care Testing (POCT) ......................................... 43
Annex B (informative) Comparison between ISO 9001:2015 and ISO 15189:2022 (this
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....................... ............... •IJ<4
Annex C (informative) Comparison between ISO 15189:2012 and ISO 15189:2022 (this
document) .................................................................................. ,......................................... :................................................................................... 54
Bibliography ......................................... ,.,, ............... ,....................................................................................................................................................... ,;;.61
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IS/IS015189: 2022
Introduction
The objective of this document is to promote the welfare of patients and sat is fac tion oflaborator
through confidence in the quality and competence of medical laboratories .
ti. ' Prs
This document contains requirements for the medical laboratory to plan and implement ;--H· io11 S
to address risks and opportunities for improvement. Benefits of this approach include: ino· · ~1.'>ing
the effectiveness of the management system, decreasing probability of invalid r es ults, and recl11 ·in g
potential harm to patients, labora tory personnel, the public and the environment.
The requirements for risk management are aligned with the principles of ISO 22367.
The requln~rt1ertt!5 fbr labdt'awry safety are all gtle d Wi th the prttictples bf ISO 15190.
The requirements for sampl e collection and transport are aligned with ISO 20658.1)
This document contains the requirements for point-of-care testing (POCT) and supersedes ISO 22 70,
which will be withdrawn upon publication of this document.
The format of this document is based on ISO/IEC 17025:2017.
The medical laboratory is essential to patient care; activities are provided within an ethi
nd
governance framework, that recognizes the obligations of healthcare providers to the patient_ Th se
a ctivities are undertaken in a timely manner to meet the needs of all patients and the pe rs nn el
responsible for the care of those patients. Activities include arrangements for examination requ ests,
patient preparation, patient identification, collection of samples, transportation, processing of p t ient
samples, selection of examinations that are fit for intended use, examination of samples, samples torage,
as well as subsequent interpretation, result reporting and advice to laboratory users. This m ay a Iso
include the provision of results to the patient, arrangements for urgent testing and the notific at ion of
critical results.
While this document is intended for use throughout the currently recognized medical laboratory
disciplines, it can effectively be applied to other healthcare services, such as uiagnoslic im ag in g,
respiratory therapy, physiological sciences, blood banks and transfusion services.
The use of this document facilitates cooperation between medical laboratories and other healthc a re
services, assists in the exchange of information, and in the harmonization of methods and procedures.
The comparability of patient examination results between medicallabor;:ttnriP.s, rpg;:mlless of r.i1·y or
country, is facilitated when medical laboratories conform to this document.
When a laboratory seeks accreditation, it should select an accreditation body which operates in
accordance with 150/IEC 17011, and which takes into account the particular requirements of medical
laboratories.
Comparisons between this document, ISO 9001:2015 and ISO/IEC 17025:2017 are in Annex B. The
comparison ofiSO 15189:2012 to ISO 15189:2022 (this document) is in Annex C.
1) First edition under preparation (previous edition was a Technical Specification). Stage at the time of publication:
ISO/DIS 20658:2022.
vi
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IS/ISO 15 "189 : 2022
Indian :::>tandard
MCDICAL LABORATORIES - REQUIREMENTS FOR QUALII Y
AND COMPETENCE
( Third Revision)
1 Srope
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical lahor;Jtories in developing their management sys ·rn s :rnd
assessing their competence. It is also applicable for confirming or recognizing the camp 'L ·nc · or
medical laboratories by laboratory users, regulatory authorities and accre ditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE
International, national, or regional regulations or requirements can also apply to specifi c top ics
covered in this document.
2
Normative references
The following documents are referred to in the text in such a way that some or all of thei r co nt nt
constitutes requirements of this document. For dated references, only the edition cited app li s. For
undated references, the latest edition of the referenced document (including any amendments) a ppli s.
ISO/IEC Guide 99:2007, International vocabulary of metrology associated terms (VIM]
NOTE
Basic and general concepts and
ISO/IEC Guide 99 is also known as the Joint Committee for Guides in Metrology (JCGM) 200.
ISO/IEC 17000:2020, Conformity assessment- Vo cabulary and general principles
I30/IEC 17025:2017, General reqwrementsjor the competence of testing and calibration laboratories
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and
ISO/IEC 17000 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
ISO Online browsing platform: available at https:jjwww.iso.orgLQb_p
IEC Electropedia: available at b:tl.p_sJL_~ww.e~.m:gi
3.1
bias
measurement bias
estimate of a systematic measurement error
Note 1 to entry: This definition only applies to quantitative measurements
[SOURCE: ISO/IEC Guide 99:2007, 2.18, modified- Note 1 to entry has been added.]
©ISO 2022- All rights reserved
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3.2
bioi CJgical reference interval
ref ·:renee interval
s p c ifie d interval of the distribution of values taken from a biological reference popul a tio n
No 1 to entry: A reference interval is commonly defined as th e central 95% in terva l. Anoth er size or an
asy rntn etricallocation of the reference interval could be more appropriate in particular cases.
No · 2 to entry: A reference interval can depend upon the type of primary sample (.3...2.5.) and the examination
procedure (.3..2) used.
Note l to entry: In some cases, only on e bi olog ica l reference limit is important, usually an upp er li mit, "x", Rn thi!t
llw r ~rrr.::;n rmnin e- hinlot;ir.i'll rf.fr.rr.nr.R intr,rvnl wo11lct hr, leli::i thi'ln or equi'\l to "x,".
Nol · 4 to entry: Terms such as 'normal range', 'normal valu es', and 'clinical range' are ambiguous and therefore
di o urage d.
[SOURCE: ISO 18113-1:2022, 3.1.9, modified- The EXAMPLE has been removed .]
3.3
clinica l decision limit
examination (.3...a) result that indicates a higher risk of adverse clinical outcomes, or is diagnostic for the
pr s ence of a specifc disease
Note 1 to en try: Clinical decision limits for th erapeutic drugs are called "therapeutic range".
Note 2 to entry: It is use d to determine risk of disease, to diagnose or to treat.
3.4
com mutability of a reference material
comnmtability
property of a reference material, demonstrated by the closeness of agreement between the relation
a mong the measurement results for a stated quantity in this material, obtained according to two given
measurement procedures and the relation obtained among the measurement results for other specified
matcriol!J
Note 1 to entry: The reference material in question is usually a calibrator and the other specified materials are
usually routine samples.
Note '2. to entry: It is typical that there are more than two measurement procedures available and comparison
among all applicable measurement procedures is desirable.
Note 3 to entry: Closeness of agreement of measurement results is defined in terms of fitness for purpose as
appropt·late for the mtended use of rhe reference maret'lal.
Note 4 to entry: A commutability statement is restricted to the measurement procedures as specified in a
particular comparison.
[SOURCE: ISO 17511:2020 3.10, modified- Note 2 to entry has been replaced by a new Note 2 to entry.]
3.5
competence
demonstrated ability to apply knowledge and skills to achieve intended results
[SOURCE: ISO/IEC 17021-1:2015, 3.7, modified definition.]
2
"demonstrated" added to the beginning of the
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IS/ISO 15189: 202 2
3.6
complaint
expression of dissatisfaction by any person or organization to a laboratory (.32.0_), relati • 11~ I o Ill!•
activities or results of that laboratory, where a response is expected
[SOURCE: ISO/IEC 17000:2020, 8.7, modified -The words "other than appeal" have been del •t •d, ;11)(1
the words "a conformity assessment body or accreditation body, rel ating to th e activities of t b cl t hody"
have been replaced by "a laboratory, relating to the activities or results of th at laboratory".]
3.7
consultant
person w ho pr ovides exper t adv ice professionally
3.8
examination
set of operations having the objective of determining the numerical value, text value or chara ·t r i ~L i c~
of a property
Note 1 to entry: An examination may be the total of a number of activities, observations or m eas u r •m e nts
required to determine a value or characteristic.
Note 2 to entry: Laboratory examinations that determine a numerical value of a property are called "qu ;mt i aLiv
examinations"; those that determine the characteristics of a property are called "qualitative examin ati ons".
Note 3 to entry: Laboratory examinations are also called "assays" or "tests".
3.9
examin9tion procedure
specifically described set of operations used in the performance of an examination (.3...8.) accor d ing to a
given method
Note 1 to entry: In the IVD medical device industry and in many laboratories that use IVD medical d vices, a n
l11t Llt ud,
analytical procedure or test procedure.
ex;:~ min fl ti rm pnH·f"rl ure fo r an analyte in a biolo ~i(.;~l Pi:Unpl a in qnmmnnly rrfr rrr rl tn 1'1~ r1n r~nr~ l y l i•
[SOURCE: ISO 15198:2004, 3.7, modified "specifically described set of operations".]
"set of operations described specifically" cha nge d to
3.10
external quality assessment
EQA
P.valuation of participant perfonn;::mce cip;flin:>t Prl?-(?:'itFihli::;hr.n r: ritP.ri n hy lll fflll'i nf i tllt-> rl;th nra tory
compansons
Note 1 to entry: Also known C\ ~ pro fici ~ n (;y t r. ~tine (PT)
[SOURCE: ISO/IEC 17043:2010, 3.7 modified - The term "external quality assessment", which was
given in Note 2 to entry, is used as the main term. Notes to entry 1 and 2 have been omitted and a new
Note 1 to entry added.]
3.11
impartiality
objectivity with regard to the outcome of tasks performed by the medica/laboratory (.3.2.0)
Note 1 to entry: Objectivity can be understood as freedom from bias or freedom from conflicts of interest.
Note 2 to entry: Other terms that are useful in conveying the element of impartiality include "independence",
"lack of prejudice", "neutrality", "fairness", "open-mindedness", "even-handedness", "detachment", "balance".
[SOURCE: ISO/IEC 17000:2020 5.3 modified- "outcome of a conformity assessment activity" has been
changed to "tasks performed by the medical laboratory". Note 2 to entry has been added.]
3
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IS/ISO 15189 : 2022
3.12
inr·r-rJ (I hor(Jtory romp(! ri <~on
orr,• ni za tion, performance and evaluation of meas urements or examinations (.3.. ) on the sa me or similar
111 01 1 e1·ia ls by two or more independ ent labora tori es in acco rdance with pre-d etermin ed con ditions
[~O URCE: ISO/IEC 17043:2010 3.4, modified- "tes ts" has been replaced by "exa minations". "items" has
b
n r eplaced by "materials". "laborator ies" ha s been replaced by "independ en t laborato ri es".]
3.13
in crnal quality control
IQC
quality control
QC
inl •rnal procedure which monitors the testing process to verify the system is workin g correctly an d
giv s confi dence that the results are reli able enough to be released
[SOURCE: ISO/TS 22583:2019 3.9, modified- "decide" ha s been replaced by "verify". Note 1 to entry
has been removed .]
3.14
in vitro diagnostic medical device
IVD medical device
device, whether used alone or in combination, intended by the manufacturer for the in vitro examination
of s pecimens derived from the human body solely or principally to provide information for diagnostic,
monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen
receptacles, software, and related instruments or apparatus or other articles
[SOURCE : ISO 18113-1:2022,3.1.33, modified- "medical" has been removed from the beginning of the
definition. "and including reagents, calibrators, control materials, specimen receptacles, software, and
related instruments or apparatus or other articles" has been added to the end of the definition. Notes 1
a nd 2 to entry have been removed.]
3.15
laboratory management
person(s) with responsibility for, and authority over a laboratory (.3..2.Q)
Note 1 to entry: Laboratory management has the power to delegate authority and provide resources within the
laboratory.
Note 2 to entry: The laboratory management includes the laboratory director(s) and delegates together with
individuals specifically assigned to ensure the quality of the activities of the laboratory.
3.16
laboratory user
individual or entity requesting services of the medica/laboratory (3 .20)
Note 1 to entry: Users can include patients, clinicians, and, other laboratories or institutions that send samples
for examination.
3.17
management system
set of interrelated or interacting elements of an organization to establish policies and objectives, and
processes to achieve those objectives
Note 1 to entry: This was formerly referred to and is synonymous with "quality management system".
Note 2 to entry: The management system elements establish the organization's structure, roles and
responsibilities, planning, operation, policies, practices, rules, beliefs, objectives, and processes to achieve those
objectives.
[SOURCE: ISO 9000:2015, 3.5.3 modified Note 1 to entry has been added.]
4
Notes to entry 1, 3 and 4 have been removed and a new
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IS/ISO 15 189 : 202 2
3.18
mea~ur~m~nt. ;u~r.urflf.¥
accuracy of measurement
accuracy
closeness of agreement between a measured quantity value and a true quantity value of a me
tS ll r;tnd
Note 1 to entry: The concept 'measurement accuracy' is not a quantity and is not given a numerica l qu :111 Li ly
value. A measurement is said to be more accurate when it offers a smaller measurement error.
Note 2 to entry: The term "measurement accuracy" should not be used for measurement trueness an c.l h ' L •rtrt
measurement precision should not be used for 'measurement accuracy', which, however, is related to b ol h 1h •st•
concepts.
Nule 3 to emry: 'Measurement accuracy' is sometimes understood as closeness of agreement between nt as ured
quantity values that are being attributed to the measurand.
[SOURCE: ISO/IEC Guide 99:2007, 2.13]
3.19
measurement uncertainty
MU
non-negative parameter characterizing the dispersion of the quantity values being attribut d Lo a
measurand, based on the information used
Note 1 to entry: MU includes components arising from systematic effects, as in the case of correcti ns to the
assigned quantity values of measurement standards. Sometimes estimated systematic effects are not co rrected
for, but instead, the associated MU components are incorporated.
Note 2 to entry: The parameter may be, for example, a standard deviation (SD) called standard MU (or a sp ecified
multiple of it), or the half-width of an interval, having a stated coverage probability.
Note 3 to entry: MU comprises, in general, of many components. Some of these may be evaluated by Type A
evaluation of MU from the statistical distribution of the quantity values from series of measurements and ca n
hP rharacterized by SD. The other components, which m::~y be e valuat~d Ly Ty J.H:! B evaluation of !VIU, can also be
characterized by SD or evaluated from probability density functions based on experience or other inform ation.
Note 4 to entry: In general, for a given set of information, it is understood that the MU is associated with a stated
quantity value attributed to the measurand. A modification of this value may result in a modification of the
associated uncertainty.
Nul~: S Lu tHILt y: All llll!JUUI 'l! llll!tlt!; have bids LLlj and Illl!Jt'ecisiuu. ~'ur example, replicate measurem ents of a
sample performed under repeatability conditions generally produce different values for the same m easurand.
Because the different values could all be reasonably attributed to the same amount of measurand, there is
uncertainty as to which value should be reported as the value of the measurand.
Note 6 to entry: Based on available data about the analytical performance of a given measurement procedure,
an estimation of MU provides an interval of values that is believed to include the actual value of the measurand,
with a stated level of confidence.
Note 7 to entry: Available data about the analytical performance of a given measurement procedure typically
comprise uncertainty of calibrator assigned values and long-term imprecision of IQC materials.
Note 8 to entry: In medical laboratories, most measurements are performed in singleton, and are taken to be an
acceptable estimate of the value of the measurand, while the MU interval indicates other results that are also
possible.
[SOURCE: ISO/IEC Guide 99:2007 2.26, modified ISO/TS 20914:2019 3.26.]
Notes to entry 5 to 8 have been added from
5
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IS/ISO 15189 : 2022
3.20
m 'd ical laboratory
laboratory
enlity for the examination (.3...8.) of mater ia ls derived from the human body for th e purpose of providing
inform a tion for the diagnosi s, monitorin g, management, prevention a nd tr at rnent of disease, or
ass ' ss rn ent of health
Nol c 1 to en try: The laboratory can also provid e advice covering all aspects of examinations in cluding appropriate
, I L. l iu11, Ll tL ilttLI prct tion ofl' JultJ on luI viae on ful'th cr mwminotion o.
Not e 2 to entry: Labora tory ac tiviti es in clud e pre-examination (.3..21), examination (.3.Ji) and post-examination
prrwesses (.3...2.3.).
Note 3 to entry: Mat erials for examina tion (J....8.) includ e but a re not limited to, microbiologica l, immunological,
bio ·hc mi ca l, immunohaematological, haematological, biophysical, cytological, ti ssue a nd cell s, a nd genetic
111 a 1erial.
3.21
patient
per on who is the source of material for an examination (.3...8.)
3.22
point-of-care testing
POCT
examination (3.,.8.) performed near or at the site of a patient (3..2J.)
[SO URCE: ISO/TS 22583 :2019, 3.11]
3.23
post-examination processes
processes following the examination (3....8.) including review of results, formatting, releasing, reporting
and re tention of examination results, retention and storage of clinical material, sample (3.2..8) and waste
disposal
3.24
pre-examination processes
processes that start, in chronological order, from the user's request and include the examination l.:i..liJ
request, preparation and identification of the patient (3.,21), collection of the primary sample(s) (.325_),
transportation to and within the laboratory (.3.2..Q), ending when the examination (3....8.) begins
3.25
primary sample
specimen
discrete portion of a body fluid or tissue or other sample associated with the human body taken for
examination (3....8.), study or analysis of one or more quantities or characteristics to determine the
character of the whole
Note 1 to entry: The International Medical Device Regulators Forum (IMDRF) uses the term specimen in its
harmonized guidance documents to mean a sample of biological origin intended for examination by a medical
laboratory CL2..Q).
[SOURCE: ISO 18113-1:2022, 3.1.65, modified- Note 1 to entry has been modified. Note 2 to entry has
been deleted.]
3.26
quality indicator
measure of the degree to which a large number of characteristics of an object fulfils requirements
Note 1 to entry: Measure can be expressed, for example, as% yield(% within specified requirements),% defects
(% outside specified requirements), defects per million occasions (DPMO) or on the Six Sigma scale.
6
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IS/ISO 15189 : 2022
Note 2 to entry: Quality indicators can measure how well an organization meets the needs and requi t' ' til •ut .· of'
users and the quality of all op erational processes.
3.27
referral laboratory
external laboratory (.3...2.Q) to which a sample or data is submitted for examination (.3..J3.)
Note 1 to entry: A referral labor atory is one to which laboratory management chooses to submit a sam pl u or s ub ·
sample for examination, data for analysis or interpretation, or when routine examinations cannot pe c ar rl •ri ll! II .
Note 2 to entry: This differs from a laboratory to which submission of samples is required by regulat io u, or 01 so
called referen ce ICJh oratory, e.g. puhli c health, foren sic, tumour I'L!gisl ry, o r ;:~ central (parent) facilil y tu w l tid t
submiss ion of sampl es is required by structure.
3.28
sample
one or more parts taken from a primary sample (3...2..5.)
3.29
trueness
measurement trueness
closeness of agreement between the average of an infinite number of replicate measured quantity
values and a reference quantity value
Note 1 to entry: Measurement trueness is not a quantity and thus cannot be expressed numerically, but meas ures
for closeness of agreement are given in ISO 5725-1.
Note 2 to entry: Me asurement trueness is inversely related to systematic measurement error, but is not related to
random measurement error.
Nate 3 to entry: 'Measurement accuracy" should not be used for 'measurement trueness'.
Note 4 to entry: For qualitative examinations, trueness of measurement (closeness of agreemen t) ca n be
expressed in terms of con cordance (i.e. percent agreement with a reference examination) .
Note 5 to entry: Trueness is a property of the examination procedure (.3..2) that reflects the bias (.3...1) of th e
measurements from the expected or target value. It is described qualitatively as good or bad. An examination
procedure (.3.,2) has good trueness if the bias (l l) of the measurements is acceptable.
[SOURCE: ISO/IEC Guide 99:2007, 2.14, modified- Notes to entry 4 and 5 have been added.]
3.30
turnaround time
dapsed time between two SJJecilieu points through pre-examination C-3.24'), examination (.3.....8), and postexamination processes (.323.)
3.31
validation
confirmation of plausibility for a specific intended use or application through the provision of objective
evidence that specified requirements have been fulfilled
Note 1 to entry: Objective evidence can be obtained through observation, measurement, examination or by other
means.
Note 2 to entry: The word "validated" is used to designate the corresponding status.
Note 3 to entry: Specified requirements of an examination method may include the following performance
specifications: measurement trueness, measurement precision including measurement repeatability, and
measurement intermediate precision, analytical specificity, including interfering substances, detection limit and
quantitation limit, measuring interval, clinical relevance, diagnostic specificity and diagnostic sensitivity.
[SOURCE: ISO/IEC 17000:2020, 6.5, modified- Notes 1 to 3 to entry have been added.]
7
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IS/IS 0 15189 : 2022
3.32.
v ·ri ilc.:a tion
co nf irmation of truthfuln ess, t hrougl I h provision of objective vid n · • Lh(lL sp cifi ed requirements
havebee n fulfilled
l·.X t\ NPLE 1
Confirm ation that pcr fo rm 8ncc s pec ifications of a meas urin g system ar achieved.
EX!\NPLE 2
Confirmation th at a target 111 •asure ment un certainty ca n be met.
Nol · l to entry: Verification is th e pro cess by which the laboratory co nfirms th at the estab lished performance
clalrns of a measuring system, e.g. tru eness, precision, reportable range, can be repli cate d in the laboratory
b fnn hum an sa mpl e exa mination i p rform d.
Not 1 to entry: Th e objective evid ence neede d for a verification can be th e resul ts of an inspection, or other
form sof determination, such as performing altern ative calculations or reviewing documents.
Note 3 to entry: Verification may be sufficie nt to impl ement a new IVD device und er circumstances where th e
examination (:i.B) is performed and used in th e mann er as directed in th e package in se rt.
No te 4 to entry: Th e word "verified" is use d to des ign ate the corresponding statu s.
[SOURCE: ISO/IEC 17000:2020, 6.6 modified- EXAMPLES 1 and 2 have been added . Notes to entry 1 to
4 have been a dded.]
4
Ceneral requirements
4.1
Impartiality
a)
Lab oratory activities sha ll b e und er taken impartially. The laboratory shall be structured and
ru a nage d to safeguard impartiality.
b)
The laboratory management shall be committed to impartiality.
L)
'1'lt~ idl.Jut dLUJ y ~ltdll l.Jt: 1 t:~!JUlt~iLl e fu r Lite itli!Jdrliality of it3 l ~bo l'.!lto i'Y nctivitic3 and 3hall not
allow commercial, financial or other pressures to compromise impartiality.
cl)
The laboratory shall monitor its ac tivities and its relationships to identify threats to its impartiality.
Thi s monitoring shall include relation ships of its personnel.
NOTE
A relationship chat rhreatens the lmpar tlal!Ly uf Lhe Ial.Juralut y Ldll l.Je Ud!>e u u11 uwuership,
governance, management, personn el, shared resources, finances, contracts, marketing (including branding),
and payment of a sales commiss ion or other inducement for the referral of new laboratory users, etc. Such
r elationships do not necessarily present the laboratory with a threat to impartiality.
e)
If a threat to impartiality is identified, the effect shall be eliminated or minimized so that the
impartiality is not compromised. The laboratory shall be able to demonstrate how it mitigates such
threat.
4.2
4.2.1
Confidentiality
Management of information
The laboratory shall be responsible, through legally enforceable agreements, for the management of all
patient information obtained or created during the performance of laboratory activities. Management
of patient information shall include privacy and confidentiality. The laboratory shall inform the user
and/or the patient in advance, of the information it intends to place in the public domain. Except for
information that the user and/or the patient makes publicly available, or when agreed between the
laboratory and the patient (e.g. for the purpose of responding to complaints), all other information is
considered proprietary information and shall be regarded as confidential.
8
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IS/ISO 15 189 : 2022
4.2.2
Release of information
When the laboratory is required by law or authorized by contractual arrangements o rel e ;:t ~(.!
confidential information, the patient concerned shall be notified of the information releas ' d, 11111 'ss
prohibited by law.
Information about the patient from a source other than the patient (e.g. complainant, regul a t(')r) ~ h ~tll
be kept confidential by the laboratory. The identity of the source shall be kept confident i I by til
laboratory and shall not be shared with the patient, unless agreed by the source.
4.2.3
Personnel responsibility
Personnel, including any committee members, contractors, personnel of external bodies, or inrl ivicltt ;tl s
with access to laboratory information acting on the laboratory's behalf, shall keep confid ttli al all
information obtained or created during the performance of laboratory activities.
4.3
Requirements regarding patients
Laboratory management shall ensure that patients' well-being, safety and rights are the prim a ry
considerations. The laboratory shall establish and implement the following processes:
a)
opportunities for patients and laboratory users to provide helpful information to aid the la bo ratory
in the selection of the examination methods, and the interpretation of the examination re ul ts;
b)
provision of patients and users with publicly available information about the examination proc ss,
including costs when applicable, and when to expect results;
c)
periodic review of the examinations offered by the laboratory to ensure they are clinically
appropriate and necessary;
d)
where appropriate, disclosure to patients, users and any other relevant persons, of incid ents that
resulted or could have resulted in patient harm, and records of ;~ctinn~ Inl<t-'rt lu mitig ate thoca
hanns;
e)
treatment of patients, samples, or remains, with due care and respect;
f)
obtaining informed consent when required;
g)
ensuring the ongoing availability and integrity ofn~tained patient samples and records in th e event
of the closure, acquisition or merger of the laboratory;
h)
making relevant information available to a patient and any other health service provider at the
request of the patient or the request of a healthcare provider acting on their behalf;
i)
upholding the rights of patients to care that is free from discrimination.
5 Structural and governance requirements
5.1
Legal entity
The laboratory or the organization of which the laboratory is a part shall be an entity that can be held
legally responsible for its activities.
NOTE
For the purposes of this document, a government laboratory is deemed to be a legal entity on the basis
of its government status.
9
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IS/IS 015189 : 2022
S.:l
Laboratory director
5.£.:1
Laboratory dire ctor compete nce
Th ' lab oratory sha ll be di re ·t d by a pe rson, or person s however na med, with th e s pecified
q11 :a l Hic ations, competence, d I at •d authority, res ponsibility, a nd reso urc es to ful fil th e r equirements
of I h is clo cum ent.
5. 2. 2
Laboratory d irector responsi bilities
Til labo rato ry directo r is I'CS j.JU IISiLJi e ru r the irnj.Ji ell ie ll ta ti on ofth 111 nagc mcnt ~y~ t c m , including th e
app l jcation of r isk management to a ll pec ts of the labora tory operations so that ri sks to patient ca r e
and oppor tuniti es to improve are syste mat ically id entifi e d and addressed.
Th d11 lies and responsibili tie ofth laboratory director shall be doc um ented .
5.2.3
Delegation of duti es
Th e labora tory director may del ega te either selected duties or r es ponsibilities, or both, to qu alified and
co mpete nt pers onnel a nd such delega tion shall be documented. However, the laboratory director shall
ma intain the ultim ate res pons ibility for the overall operation of the laboratory.
5.3
Laboratory activities
5.3.1
General
The laboratory shall specify a nd do cument the range of laboratory activities, including laboratory
ac tiviti es performed at sites other than the main location (e.g. POCT, sample collection) for which it
co nforms with this document The laboratory shall only claim conformity with this document for this
ra ng e of laboratory activiti es, which excludes externally provided laboratory activities on an ongoing
u a~ b.
5.3.2
Conformance with requirements
Laboratory activities shall be carried out in such a way as to meet the requirements of this document,
th e users, regulatory authorities and organizations providing recognition. This applies to the complete
range of specified and documented laboratory activities, regardless of where the service is provided.
5.3.3
Advisory activities
Laboratory management shall ensure that appropriate laboratory advice and interpretation are
available and meet the needs of patients and users.
Tht: la)-lQratorv ~hall estAblish arrangements for communicating with laboratory users on the followin~
when applicable:
a)
advising on choice and use of examinations, including required type of sample, clinical indications
and limitations of examination methods; and the frequency of requesting the examination;
b)
providing professional judgments on the interpretation of the results of examinations;
c)
promoting the effective utilization of!aboratory examinations;
d)
advising on scientific and logistical matters such as instances of failure of sample(s) to meet
acceptability criteria.
10
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IS/ISO 1S189 : 2022
Structure and authority
5.4
5.4.1
General
The laboratory shall:
a)
define its organization and management structure, its place in any parent organizatioJ 1, r111d I h •
relationships between management, technical operations and support services;
b)
specify the responsibility, authority, linP.s of r.nmmnniration and interrelationship of all J>Cr:;o nn •I
who mandge, 1-Jt:!l fUJJII ut · ve!'lfy work affeCt111g the results ot lnhorntnry rJrtivitiP<:;
L)
\tJ~l I ry ll tJl"UL'I:'lllll'~S LU th~ e.• tetH necessary to ensure the consistent application or its I l lwr ··rLory
activities and the validity of the results.
5.4.2
Quality management
The laboratory shall have personnel who, irrespective of other responsibilities, have the auth orily
resources needed to carry out their duties, including:
.,,,d
a)
implementation, maintenance and improvement of the management system;
b)
identification of deviations from the management system or from the procedures for p rform in g
laboratory activities;
c)
initiation of actions to prevent or minimize such deviations;
d)
reporting to laboratory management on the performance of the management system and any need
for improvement;
e)
ensuring the effectiveness of laboratory activities.
Till " " '~-'' 1 ''111 i!Jlllll ~ L::ill lHI U!J!Jll:lliUll tU tlrtb tll' l'l'lol"c pcr.'Jon 3.
NOTE
5.5
a)
Objectives and poli ci ~::s
Laboratory management shall establish and maintain objectives and policies (see .82) to:
1)
me~t thP. nP.P.rls r1nrl rPrJUirement s of its patients and UtJOrDl
2)
commit to good professional practice;
3)
provide examinations tl1dl fulfil Lltei1 iulewletl use;
4)
r.onform to this document.
b)
Objectives shall be measurable, and consistent with policies. The laboratory shall ensure that the
objectives and polir.ies are implemented at all levels of the bboratory organization.
c)
Laboratory management shall ensure that the integrity of the management system is maintained
when changes to the management system are planned and implemented.
d)
The laboratory shall establish quality indicators to evaluate performance throughout key aspects
of pre-examination, examination, and post-examination processes and monitor performance in
relation to objectives (see .8. •.8...2)-
NOTE
Types of quality indicators include the number of unacceptable samples relative to the number
received, the number of errors at either registration or sample receipt, or both, the number of corrected reports,
the rate of achievement of specified turnaround times.
11
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IS/JS«:>15189: 2022
5.6
Risk management
a)
Laboratory management sh;, ll '. I ;1h lish, im plemen t, and maint a in pro · ss s for identifying risks ot
1::1arm to pati ents and opporLun ili ~s for im proved pat ient care asso ia L d with its exam ina tions and
activities, a nd develop ac tion s to ;1cldress both ri sks and opportuniLi s fCJr improvement (see 8...5.).
b)
"J'h labor atory director sh a ll ensure that th ese processes are evalu at d for effec tiveness and
modified, when identified as b ing in f"fect ive.
I
NOTE 1
ISO 22367 provid es deta il s for managing risk in medi ca l laboratories.
N TE 2
ISO 35001 provides d e t ;:~ iL for l<t boratory biorisk management.
6 Resource requirements
6.1
General
Th labora tory shall have ava il able the personnel, facilities, equipm ent, reagents, consumables and
supp ort se rvic es nec essa ry to manage a nd perform its activities.
I
6.2
Personnel
6.2.1
General
a)
'Th laboratory shall have access to a sufficient number of competent persons to perform its
activities.
b)
All personnel of the laboratory, either internal or external, that could influence the laboratory
activities shall act impartially, ethically, be competent and work in accordance with the laboratory's
management system.
NOTE
JSOJTS 22583 provides gu id ance for supervisors and operators of POCT equipment.
c)
The laboratory shall communicate to laboratory personnel the importance of meeting the needs
and requirements of users as well as the requirements of this document.
d)
The laboratory shall have a programme to introduce personnel to the organization, the department
or art! a In Whldt Lhu I.Jl!t'!>Ull w lll wut k, Ll w Letutt.. Jlltl LUtttliliuu:, uf t: ttt]Jiuy JuLilt, Jtaff facilitica,
hea lth and safety requirements, and occupational health services.
6.2.2
Competence requirements
a)
The laboratory shall specify the competence requirements for each function influencing the results
of laboratory activities, including requirements for education, qualification, training, re-training,
technical knowledge, skills and experience.
b)
The laboratory shall ensure all personnel have the competence to perform laboratory activities for
which they are responsible.
c)
The laboratory shall have a process for managing competence of its personnel, that includes
requirements for frequency of competence assessment.
d)
The laboratory shall have documented information demonstrating competence of its personnel.
NOTE
Examples of competence assessment methods that can be used in any combination include:
direct observCl,tion of an activity,
monitoring the recording and reporting of examination results,
12
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r ' vi •w of wo l'l< r •c'CII'd s,
:I SS!'.SS IIl('ll( (If prolil\'lll ·SI) Ivi n(•, :ki ll .',
vx :111lill ~l l ion of Sp ·ri ~dl y pi'O Vi (l(' li S:l lllpl 'S 1 l'. J',. pi' ·viOIISiy 'X:I Illill •(I ,' ~lllipl cS, ill t rl a bOI'::lt() l'y C'()11 1p:il'i Sllll
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6.:l.3
Au thol"iza tiou
TIP la bo ra tory s h" II . uth ori z 1 rso nn •I top rfonn s p '<.: ifi t: I<boratory act iviti es, in clu d ing but no t
limil ' d to, th following:
·I ·clion, d vc·lo pm rnt , rnodifi ·a Lion, v:tlidr1Lion a nd v rifi c::tLion ofrn thod s;
"I
b)
review, r ·I ·as', and t' ' porli n' orr ·s uIts;
c)
us of la bora tory in fo rm at io n sys te ms, in r a rti ·ul r: cc ss in • pat ie nt data a nd in fo rtn a ti on,
e nter ing p::tticnt cl a t a nd xa min Li n r s ui ts, h nging p t ie nt da ta or exam in a t ion r suits .
6.2.4
Continuing ed ucation and professional development
A co ntinuin g edu cat ion programm e s ha ll be ava il able to perso nnel who participa te in ma nage ri al a nd
technical processes. All pe rsonn el s ha ll participate in cont inuin g education a nd regular pro fess ion a l
developm e nt, or ot her profess ional li a is on activ it ies .
The s uitab ility of t he programm es and act ivities shall be periodically reviewe d.
6.2 .5
Personnelrec01·ds
Th e laboratory sh all have procedures and retain records for:
a)
determining th e competence requirements specified in .6...22 a);
b)
position descriptions;
c)
training and re -training;
d)
authorization of personnel;
e)
monitoring compete nc:e nfp P.rsnnnPl
6.3
Facilities and environmental conditions
6.3.1
General
The facilities and environmental conditions shall be suitable for the laboratory activities and shall not
adversely affect the validity of resu lts, or the safety of patients, visitors, laboratory users, and personnel.
This shall include pre-examination related facilities and sites other than the main laboratory premises
where examinations are performed, as well as POCT.
The requirements for facilities and environmental conditions necessary for the performance of the
laboratory activities shall be specified, monitored, and recorded.
NOTE 1
ISO 15190 provides details for facility and environmental conditions.
NOTE 2 Environmental conditions that can adversely affect the validity of results include, but are not limited
to: adventitious amplified nucleic acid, microbial contamination, dust, electromagnetic disturbances, radiation,
lighting conditions (illumination), humidity, electrical supply, temperature, sound and vibration.
13
Supplied by BSB I don undrll lho llconso from BIS for Quallly Auslrla Cenlral Asle Pvt Lid . Nold ( lmron.Gnl1o® qacamall.com) II ' nrlrh•'
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6.3.2
Facility controls
Fii cll ity controls shall b imr>l '111 ., ,L d, recorded, monitored, periodi ;a ll y r vi ewed, a nd shall include:
a} COIJtrol of access, takin g int o ' ons id ration safety, confidenti ali ty, qu a l iLy, a nd sa feguarding medical
information a nd pati ent sa m pi s;
b)
prevention of co ntamination, interference, or adverse in flu nces n laboratory ac tivities that can
arise from energy so urces, li 'hting, ventilation, nois e, water and wast disposal;
c)
prevention of cross-contamin a tion, where examination procedures pose a risk, or where work can
bel ffected or influenced by loc k of separation;
d)
pnvision of safety facllltl e ·a nd devi ces, where applicable a nd regul a rly verifying their funcliuning;
E X/\ MPLES
Th e operation of emergency r elease, intercom and alarm systems for cold rooms and walk-in
freezers, accessibility of emerge ncy showers, eyewash and r esuscitation equipment.
e)
maintenance oflaboratory fac ilities in a functional and reliable cond ition.
6.3.3
Storage facilities
a}
Storage space, with conditions that ensure the continuing integrity of sa mples, equipment, reagents,
con s umables, docum ents and r ecords, shall be provided.
b)
Patient samples and materials used in examination processes shall be stored in a manner that
prevents cross contamination and deterioration.
c)
Storage and disposal facilities for hazardous materials and biological waste shall be appropriate to
the classification of the materials in the context of any statutory or regulatory requirements.
6.3.4
Personnel facilities
Th ere shall be adequate access to toilet facilities and a supply of drinking water, as well as facilities for
storage of personal protective equipment and clothing.
Space for personnel activities, such as meetings, quiet study and a rest area, should be provided.
6.3.5
Sample collection facilities
Sample collection facilities shall:
a)
enable collection to be undertaken in a manner that does not invalidate results or adversely affect
the quality of examinations;
b)
consider privacy, comfort and needs (e.g. disabled access, toilet facility) of patients and
accommodation of accompanying persons (e.g. guardian or interpreter) during collection;
c)
provide separate patient reception and collection areas;
d)
maintain first aid materials for both patients and personnel.
NOTE
14
ISO 20658 provides details for sample collection facilities.
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IS/ISO 15189 : 2022
6.4
Eq uipm •nt
6.4.1
G •n ·nd
Th e labo ra tory s ha ll hclv · pror ss "·s fo r t·h s •lec t io n, [J ro ctlr '11 1 ·nt, in sta ll at ion, cc pla n · · l(•. ·ting
(includin g :1c · ·p i a bi Iity -r iter i J, ha ndling, tr ns por t, s t or:lg<', 11 s , m in tena nee, nd de t:on 1111 i.'s ion i ng
of quipm •nt, in cmJ ·r lo ensure prop e r fun ct·ionin e t111tl to pr ·ve nl co nta min a tion or dete ri cwation .
NOTE
I. ahur. ory eq uipm ent includ es ha rdware and soflwar · of in strum ents, meas uring sy •ms, anti
laborato ry i11formatio11 syste ms, or 11y eq uipm e11 t that i11 111 ' II · ·s lh r •su its of laborato ry act ivi ti s, in ·lutli11g
sam pi Lra 11 spo rl :1Lion sysLc ms.
6.4.l
l::quipmcnl requirements
a)
Th e labo r tory sh II have cc ss to q uipm e nL re4ui r Jtl for the correct perfor ma nc of l<1 hora tory
act ivi t i s.
b)
Wh ere th e equipm ent is use d outs id e th e laborato ry's permanent co nt ro l, or e quipm •nl
manufacturer's functional spec ifi cat ion, laboratory ma nage ment s ha ll ens ure that th e requir 111 n ts
of thi s docum ent a re met.
c)
Each it 111 of equipment that ca n influ ence laboratory act iviti es shall be uniquely Iabell d , 111 rk d
or oth e rwi s identified and a regi s ter mainta in ed.
d)
Th e laboratory shall maintain and replace eq uipm ent as needed to ensure th e quality of exa mination
results.
6.4.3
Equipment acceptance procedure
The laboratory shall verify that the equipment conforms to s pec ified acceptability criteri a b efore being
placed or returned into service.
Equipm ent used for mea surement shall be capable of achi eving either the measuren-1ent acc uracy or
measurem ent uncertainty, or both, required to provid e a valid res ult (see 13.3 and L.l...4 for details) .
NOTE 1 This includes equipment used in the laboratory, equipm ent on loan, or equipment used in point of care
settings, or in associated or mobile faciliti es, authorized by the laboratory.
NOTE 2
The vei'iflcatlon of equipm ent acce!J lauce Le!;ling can be, where relevant, based on the calibration
certificate of the returned equipment.
6.1·.1·
Equipment instructions for use
a)
The laboratory shall have appropriate safeguards to prevent unintended adjustments of equipment
that can invahdate examination results.
b)
Equipment shall be operated by trained, authorized, and competent personnel.
c)
Instructions for the use of equipment, including those provided by the manufacturer, shall be
readily available.
d)
The equipment shall be used as specified by the manufacturer, unless validated by the laboratory
(see 13.3).
6.4.5
a)
Equipment maintenance and repair
The laboratory shall have preventive maintenance programmes, based on manufacturer's
instructions. Deviations from the manufacturer's schedules or instructions shall be recorded.
15
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IS/IS 0 15189 : 2022
b)
Equipment shall be m inLa in od in a safe working condition and workin g order. This shall include
ele ·trical safe ty, any em org ncy stop devices and th e sa fe h . ncllin g a nd disposal of hazardous
rna er ials by authori z -d p rso nn el.
c)
Eq11ipment that is defectiv - or outs ide specified requirements, shall b ta ken out of service. It shall
be ·]ea rly labell ed or ma rk d as being out of service, until it has b - n v rifi ed to perform correctly.
The laboratory shall exa min e th e effec t of the defect or devi ation fr om spec ified requirements and
shall initiate actions wh en non- co nforming work occurs (see zLr: ).
d)
Wh en applicable, th e laboratory shall decontaminate eq uipm ent before service, repair or
decommissioning, provid e suitable space for repairs and provid e ap propriate personal protective
e quipm ent.
6.4-.6
Equipment adverse incident reporting
Adve rse incidents and accidents th at can be attributed directly to spec ific equipment shall be
investigated and r epo rted to either th e manufacturer or supplier, or both, an d appropriate authorities,
as r quired.
Th e laboratory shall have pro ced ures for responding to any manufacturer's recall or other notice, and
taking actions recommended by the manufacturer.
6.4. 7
Equipment records
R cords shall be maintained for each item of equipment that influences the results of laboratory
act ivities.
Th es e re cords shall include the following, where relevant:
a)
manufacturer and supplier details, and sufficient information to uniquely identify each item of
equipment, including software and firmware;
u)
da tes of receipt, accep tance tes ting a lid eulei illg iulu ::,el'V ice;
c)
evidence that equipment conforms with specified acceptability criteria;
d)
the current location;
e)
condition when received (e.g. new, used or reconditioned);
f)
manufacturer's instructions;
g)
the programme for preventive maintenance;
h)
any maintenance activities performed by the laboratory or approved external service provider;
i)
damage to, malfunction, modification, or repair of the equipment;
j)
equipment performance records such as reports or certificates of calibrations or verifications, or
both, including dates, times and results;
k)
status of the equipment such as active or in-service, out-of-service, quarantined, retired or obsolete.
These records shall be maintained and shall be readily available for the lifespan of the equipment or
longer, as specified in 8.4.3.
16
Supplied by BSB Edge under the license from BIS for Quality Austria Central Asia Pvt ltd- Naida (simron.saha@qacamail.com) IP address 203.180.252.130 -- dated 23/08/2024 18:37:00 against BIS-20240823-44
IS/ISO 15"189: 2022
6.5 Equipment calibration and metrological traceability
6.5.1
General
The laboratory shall specify calibration and traceability requirements that are sufficient to mai rll<irt
consistent reporting of examination results. For quantitative methods of a measured ~nt a l y t •,
specifications shall include calibration and metrological traceability requirements. Qualitative 111 •Lhods
and quantitative methods that measure characteristics rather than discrete analytes shall sp • ·i ly Lhe
characteristic being assessed and such requirements necessary for reproducibility over time.
NOTE
Examples of qualitative methods and. quantitative methods that may not allow m e trol ol'. il";-~1
traceability include red cell antibody detection, antibiotic sensitivi ty assessment, gene tic testing, er ylhro y1 e
sedimentation rate, flow cytometry marker staining, and tumour HER2 immunohistochemical stainin •
6.5.2
Equipment calibration
The laboratory shall have procedures for the calibration of equipment that directly or indirectl y aff cLs
examination results. The procedures shall specify:
a)
conditions of use and manufacturer's instructions for calibration;
b)
recording of the metrological traceability;
c)
verification of the required measurement accuracy and the functioning of the measuring system at
specified intervals;
d)
recording the calibration status and date of re-calibration;
e)
ensuring that, where correction factors are used, these are updated and recorded wh en recalibration occurs;
f)
handling of situations when calibration was out of control. to minimize risk to sP.rvin' operation
.ua1Lu 1J::tlll:JJ1Lti,
6.5.3
a)
Metrological traceability of measurement results
The laboratory shall establish and maintain metrological traceability of its measurement results
by means of a documented unbroken chain of calibrations, each contributing to the measurement
uncertainty, linking them to au dJJJJl UJJt iale 1 efereuce.
NOTE
Information of traceability to a higher order reference material or reference procedure can
be provided by an examination system manufacturer. Such documentation is acceptable only when the
manufacturer's examination system and calibration procedures are used without modification.
b)
The laboratory shall ensure that measurement results are traceable to the highest possible level of
traceability and to the International System of Units (SI) through:
calibration provided by a competent laboratory; or
NOTE 1
Calibration laboratories fulfilling the requirements of ISO/IEC 17025 are considered
competent for performing calibrations.
certified values of certified reference materials provided by a competent producer with stated
metrological traceability to the Sl;
NOTE 2
Reference material producers fulfilling the requirements of ISO 17034 are considered to
be competent.
NOTE 3
suitable.
Certified reference material fulfilling the requirements of ISO 15194 are considered
17
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c)
lVhere it is not poss ibl ' to provi d - tracea bility accord in g to .~i. :~ a, ot her mea ns for providin g
<onfidence in th r s til .· .- hal! I>· appli ed, including but not limi t d Loth fo llowing:
results o fr fe r n ·' ln<· ~t .' trr ' 111 nt procedures, s pecified m thod s or co nse ns us standards, tha
a r e cl ea rly desc rih ·rl ~11rd <1 ·c.:epted as providing mea s ure m nl r su lls fit for their inte nded us
a nd en ured by suitahl <:omp a ri so n;
meas ureme nt of ca lihr~lLOr by a nother proc e dure.
NO'!' I::: ISO 17511 provid es lur her intorm ation on how to m na >e the co mpromrses m the metrologr ca
traceability of mea. urand s.
I)
:For genetic exami nalions, Lracc bi lily to genetic reference se qu e nc es sha ll b e establi shed .
)
:For qualitativ me thod s, traceabi lity may b e demon s trated by te t in g of known material or
pr v ious samp les s uffici nt to . how consistent id entificat ion an d, when appli cabl e, intensity o
re ction.
6.6
Reagents and consumables
6.6. :l
General
Th e laboratory shall have pro cesses for the selection, procurem ent, r eception, storage, acceptanc
test ing and inventory m a nage ment of reagents and consumables.
NOTE
Reagents include substa nces which are commercially supplied or prepared in-house, referenc
materials (calibrators and QC materials), culture media; consumables in clude pipette tips, glass slides, POCT
supplies etc.
6.6.2
Reagents and consumables- Receipt and storage
Th e laboratory shall store reagents and consumables according to manufacturers' specifications and
monitor the environmental conditions where relevant.
When the laboratory is not the receiving facility, it shall verify that the receiving facility has adequate
storage and handling capabilities to maintain supplies in a manner that prevents damage and
deterioration.
6.6.3
Reagents and consumables - Acceptance testing
Each reagent or new formulation of examination kits with changes in reagents or procedure, or a new
lot or shipment, shall be verified for performance before placing into use, or before release of results, as
appropriate.
Consumables that can affect the quality of examinations shall be verified for performance before
placing into use.
NOTE 1
Comparative IQC performance of new reagent lots and that of previous lots can be used as evidence
for acceptance (see 1..3....Z.2_). Patient samples are preferred when comparing different reagent lots to avoid issues
with commutability ofiQC materials.
NOTE 2
6.6.4
Verification can sometimes be based on the certificate of analysis of the reagent.
Reagents and consumables - Inventory management
The laboratory shall establish an inventory management system for reagents and consumables.
The system for inventory management shall segregate reagents and consumables that have been
accepted for use from those that have been neither inspected nor accepted for use.
18
Supplied by BSB Edge under the license from SIS for Quality Austria Central Asia Pvt Ltd- Naida (simron .saha@qacamail.com) IP address 203.189.252.130 -- dated 2310812024 18:37:00 against BIS-20240823-44
IS/ISO 15189 : 2022
6.6.5
Reagents and consumables - Instructions for use
Instructions for the use of reagents and consumables, including those provided by manu Jarlu rt•r.·,
shall be readily available. Reagents and consumables shall be used according to the manu fu ·t 11 r •r's
specifications. If they are intended to be used for other purposes see 23.....3_.
6.6.6
Reagents and consumables- Adverse incident reporting
ALl ve1 !:>e 111L1Lleuu, <mLl aeeJll!:!t1L~ that tan be art: lbuted directly to specitic reagents or con s u ma hiPs
shall be investigated and reported to either the manufacturer or supplier, or both, and ap]1ropri :1t ·
authorities, as required.
The laboratory shall have procedures for responding to any manufacturer's recall or other not ic und
taking actions recommended by the manufacturer.
6.6.7
Reagents and consumables- Records
Records shall be maintained for each reagent and consumable that contributes to the perfor n1 n 'e of'
examinations. These records shall include, but not be limited, to the following:
a)
identity of the reagent or consumable;
b)
manufacturer's information, including instructions, name and batch code or lot number;
c)
date of receipt and condition when received, the expiry date, date of first use and, where appli c bl ,
the date the reagent or consumable was taken out of service;
d)
records that confirm the reagent's or consumable's initial and ongoing acceptance for use.
Where the laboratory uses reagents prepared, resuspended or combined in-house, the record s sha ll
include, in addition to the relevant information above, reference to the person or persons und ertakin g
the preparation, as well as the dates of preparation and expiry.
6. 7
Service agreements
6.7.1
Agreements with laboratory users
The laborat tory ~hall have a procedu r0. to 0.rltabli3h and periodically r~v iew d gl eeutelll!J fur provld mg
loboratol'y activities.
The procedure shall ensure:
a)
the requirements are adequately specified;
b)
the laboratory has the capability and resources to meet the requirements;
c)
when applicable, the laboratory advises the user of the specific activities to be performed by
referral laboratories and consultants.
Laboratory users shall be informed of any changes to an agreement that can affect examination results.
Records of reviews, including any significant changes, shall be retained.
6.7.2
Agreements with POCT operators
Service agreements between the laboratory and other parts of the organization using laboratory
supported POCT, shall ensure that respective responsibilities and authorities are specified and
communicated.
NOTE
Established multidisciplinary POCT committees can be used to manage such service agreements as
described in Annex A.
19
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6.8
Externally provid cl produ cts and services
6.0.:::1
General
Th · labora tory sha II ens u r · t hal x t ·rn a lly provid ed prod ucts a nd s >rvi · •s t hat affect laboratory
act ivit ies a r e suitabl e wh en s 11 ·h produ ·ts a nd se rvi ces are:
a)
j nt'end ed for in corpo rat ion into Lh e laboratory's own activiti es;
b)
p rovided, in pa rt or in fu ll , directly to th e use r by th e la boratory, as received from the external
provid er;
c)
t.J~
d W 5i Upport lhe operOtLIU n uf LIH! lctlJU n tLUr y.
IL
n be necessary to co llab orate with oth er organizationa l depart ments or function s to fulfil thi
r qu ir ment.
NOTE
Services in clud e, e.g. sample coll ection services, pipette a nd ot her ca libratio n services, facility a nd
equiprr1ent ma intena nce se rvices, EQA progra mmes, referral laboratories a nd co nsu ltants.
6.8.2
Referral laboratories and consultants
Th e laboratory shall communicate its requirements to referral labo ratories and consultants who
provide interpre tation s a nd advi ce, for:
a)
th e pro cedures, exa min ations, r eports and consulting activiti es to be provided;
b)
management of critica l results;
c)
any required personnel qu alifications and demonstration of competence.
Unless otherwise specified in th e agreement, the referring laboratory (and not the referral laboratory)
sha ll be responsible for ensuring that examination results of the referra l laboratory are provided to th
person ma king the request.
A lis tnf ;:dl r PfPrrallahnratnri Rs anri r.nns1llt;:mts shall h~ mainti3inec\ ,
6.8.3
Review and approval of externally provided products and services
Th e laboratory shall have procedures and retain records for:
a)
defining, reviewing, and approving the laboratory's requirements for all externally provided
products and services;
b)
defining the criteria for qualification, selection, evaluation of performance and re-evaluation of
external providers;
c)
referral of samples;
d)
ensuring that externally provided products and services conform to the laboratory's established
requirements, or where applicable to the relevant requirements of this document, before they are
us eLl ur tlll'et:Lly jJJ 'UV lt.let.l Lu Lite u!>eJ ;
e)
taking any actions arising from evaluations of the performance of external providers.
20
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NOTI·:
For IIIO S I routin e l:rhor:rtory pmt· ·dun::, t:() ll.~ (·lll ' :Ill I>. inf•rr d wh 'II lh
sullmit. · Lo thr· s:t rnplt· l'ollt•rt inp, pror · •dnr •, for •x :nnplr·, vr·rliptrnrlur •.
ratit•nt willingly
wiLh a n in Tf' ~Jst· d risk of'
b)
'i;l. ' ', ', I' 't'OI'd •d
c)
lf oiL<lining ·ons•ntisnnlpussibl in m rg·n·y s itu~tions,th • l a bor torymay , a rryoultl'''SS<Jry
pro · dur s, provid d Lh ·y r in Lh pali nL's b •s t int r ·sL.
7 .2.4..4
Instructions fm· collection activities
To onli ur •ua fu, a cum l · n I lini . ll y ooi!J IJ'UIJI i<~Ll: :-.drrqJ I • tJII · lull <:lltt.l pre-e){a mtn CI Lion sLurag ' tit •
1
laboratory sh II ['JrOvid c inslru I ions ror:
a)
v rific tion of the id entity ofth p li ent from whom
b)
verification nd wh n relev nt, record ing that th pati nt 111 ets pre-examination r quir menls [ .g.
fastin • stat us, medication 'tatus (tim of last dos , cessation), sa mple collection at prede •rmin tl
time or time interval ];
c)
collection of primary sample , with descriptions of th primary sample co ntainers and any
necessary additives, as well as the order of sample collection, where releva nt;
d)
labe lling of primary samples in a manner that provides a n unequivocal link with the pati nt from
whom they are collected;
e)
r cording of the identity of the person collecting the primary sample and the collection date, and,
when relevant, recording of the collection tim e;
f)
requirements for separating or dividing the primary sample when necessary;
g)
stabilization and proper storage conditions before collected samples are delivered to the laboratory;
I!)
~dfe tJI!:llJU!:;;;tl Uf ll!ate!'tal
'J.:l.!:i
a)
prim ry sample is collec ted;
Used tn the collection process.
Sample transportation
To ensure the timely and safe transportation of samples, the laboratory shall provide instructions
for:
1)
packaging of samples for transportation;
2J ensuring the time between collection and receipt in the laboratory is appropriate for the
requested examinations;
3)
maintaining the temp ratun: iult:t Vdl ~!Jt:!LlfleLl ful' S;;ttriple tollettlotl and handlmg;
4)
any specific requirements to ensure integrity of samples, e.g. use of designated preservatives.
b)
If the integrity of a sample has been compromised and there is a health risk, the organization
responsible for the tl'i'ln:'ipnrt nfthP <>rtmplP <>h;:~ll be notifi~d immediatoly and action tahen to I'cduce
the risk and to prevent recurrence.
c)
The laboratory shall establish and periodically evaluate adequacy of sample transportation
systems.
23
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7. Z.6
Sampl ~ r ecfl ip t
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J
de un eq\.! Ivoca l t race bii1 ty ot· sa mpl es by requ est and labe llin g, o a uniquely Id entitled patie nt
a~ d when app li cable, th
nato mical s ite;
b)
criteria for acce pta nee a nd reject ion of sa mples;
)
r eco rdin g th e date and tim e of receipt of the sa mpl e, wh en r I v nt;
d
r~cor clln g th e lcl et1tlty of the persol'l rece!VIhg the satnple, whet11'
e)
eva luation of received sa mpl es, by authori ze d personnel, to ens ure compli ance with acceptabilitycri teria r elevant for the requ ested exa min ation(s);
f)
i nstructions for samples s pecifically marked as urgent, which in clud e details of special labelling,
transport, a ny rapid process ing method, turnaround tim es, and special reporting criteria to b e
followed;
g)
ens uring that all portions of the sample shall be unequivoc ally traceable to the original sample.
7.2.6.2
a)
levat1t;
Sample acceptance exceptions
Th e laboratory shall have a process that considers the bes t interes ts of the patient in receivin g
care, when a sam ple ha s been compromised due to
1) incorrec t patient or sa mple identification,
2) sample instability due to, for example, delay in transport,
3) incorrect storage or handling temperature,
b)
4)
inappropriate container (s), and
~)
1n snffir1ent ample volume
When a compromised clinically critical or irreplaceable sample is accepted, after consideration
of the risk to patient safe ty, the final report shall indicate the nature of the problem and where
applicable, advising caution when interpreting results that can be affected.
7.2.7
7.2.7.1
Pre-examination handling, preparation, and storage
Sample protection
The laboratory shall have procedures and appropriate facilities for securing patient samples, ensuring
sample integrity and preventing loss or damage during, handling, preparation and storage.
7.2.7.2
Criteria for additional examination requests
Laboratory procedures shall include time limits for requesting additional examinations on the same
sample.
7.2.7.3
Sample stability
Considering the stability of the analyte in a primary sample, the time between sample collection and
performing the examination shall be specified and monitored where relevant.
24
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IS/ISO 1n 1RA : "011
7.3
Examination vrm.:esses
7,;-l,1
a)
fip,nrrfll
The laboratory shall select and use examination methods which have been validated for t lwi r
intended use to assure the clinical accuracy of the examination for patient testing.
·u
NOTE
Preferred methods are those specified in the instructions for use of in vitro diagnost ir tn I ·; tl
devices or those that have been published in f.S ti!hli shPrl,l;:mth oritative tsxtboolu;, peer revic"v cl •x t.,
or journals, or in international and national consensus standards or guidelines, or national or r 'J~ion:tl
regulations.
b)
The performance specificatiom for l':Ahh r.xnminiltinn mPth od )h•tll rabto to tho intond ·d u.
that examination and its impact on patient care.
c)
All procedures and supporting documentation, such as instructions, standards, man u:a ls :J nd
reference data relevant to the laboratory activities, shall be kept up to date and be readily av;:1ilo hi
to personnel (see 11..3.).
d)
Personnel shall follow established procedures and the identity of persons performing si •nifi ·::. nt
activities in examination processes be recorded, including POCT operators.
e)
Authorized personnel shall periodically evaluate the examination methods provided by th
laboratory to ensure they are clinically appropriate for the requests received.
7.3.2
111'
Verification of examination methods
a)
The laboratory shall have a procedure to verify that it can properly perform examination methods
before introducing into use, by ensuring that the required performance, as specified by the
manufacturer or method, can be achieved.
b)
The performance specifications for the examination method confirmed during the verifi cation
process shall be those relevant to the intended use of the examination results.
c)
The laboratory shPII!':n~mr. th r. f''lftrnt nf thP "Prific11 tion of unumination method .'! i.'! uffiLi e11L Lu
ensure the validity of results pertinent to clinical de cision making.
Ll)
Pt!l'SUI!tH!l With the appropnate authorization and competence shall review the verification results
and record whether the results meet the specified requirements.
e)
If a method is revised by the issuing body, the laboratory shall repeat verification to the extent ·
necessary.
f)
The following records of verification shall be retained:
1)
performance specifications to be achieved,
2)
results obtained, and
3)
a statement of whether the performance specifications were achieved and if not, action taken.
7.3.3
a)
Validation of examination methods
The laboratory shall validate examination methods derived from the following sources:
1)
laboratory designed or developed methods;
2)
methods used outside their originally intended scope (i.e. outside of the manufacturer's
instructions for use, or original validated measurement range; third party reagents used on
instruments other than intended instruments and where no validation data are available);
25
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IS/ISO 15 189 : 2022
7.3
Examination processes
7.3.1
a)
General
The laboratory shall select and use examination methods which have been validated for t h ·lr
intended use to assure the clinical accuracy of the examination for patient testing.
NOTE
Preferred methods are those specified in the instructions for use of in vitro diagnosti · 111 ·eli ·; II
devices or those that have been published in established/authoritative textbooks, peer-revie"Y •cl L xts,
or journals, or in international and national consensus standards or guidelines, or national or r 'j' ional
regulations.
b)
The performance specifications for each examination method shall relate to the intend d us · o(
that exa mination an d its impact on patient ca re.
c)
All procedures and supporting documentation, such as instructions, standards, manu als a nd
reference data relevant to the laboratory activities, shall be kept up to date and be readily ava il abl
to personnel (see .8. . 3.).
d)
Personnel shall follow established procedures and the identity of persons performing si •n ifi ca nt
activities in examination processes be recorded, including POCT operators.
e)
Authorized personnel shall periodically evaluate the examination methods provided by th e
laboratory to ensure they are clinically appropriate for the requests received.
7.3.2
Verification of examination methods
a)
The laboratory shall have a procedure to verify that it can properly perform examination method s
before introducing into use, by ensuring that the required performance, as specified by the
manufacturer or method, can be achieved.
b)
The performance specifications for the examination method confirmed during the verifi ca tion
j.Jt UUI!:>!» !.lt::JlllJ!:! LhO t; C rclcVnht to th e mtended use ot tlte e.xaudni::I LI\m r~:mlt:'i .
c)
The laboratory shall ensure the extent of the verification of examination methods is sufficient to
ensure the validity of results pertinent to clinical decision making.
d)
Personnel with the appropriate authorization and competence shall review the verification results
and record whether the results meet the specified requirements.
e)
If a method is revised by the issuing body, the laboratory shall repeat verification to the extent ·
necessary.
f)
The following records of verification shall be retained:
1)
performance specifications to be achieved,
2)
results obtained, and
3)
a statement of whether the performance specifications were achieved and if not, action taken.
7.3.3
a)
Validation of examination methods
The laboratory shall validate examination methods derived from the following sources:
1)
laboratory designed or developed methods;
2)
methods used outside their originally intended scope (i.e. outside of the manufacturer's
instructions for use, or original validated measurement range; third party reagents used on
instruments other than intended instruments and where no validation data are available);
25
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IS/JS..0 1 ~ 189 : 2022
.:::3) v lid a t ·d rn thod s s ubse qu e ntly modifi ed .
h)
-:Cheva lid a tion s h II be as ex tens ive as is n ecessary a nd confirm, through th e provi s ion of objec tiv
~vide n c in th form of p erformance s pecificat ions, tha t the specific requirements for th e intended
.___1-se f th x rn in a t ion have been fulfill ed. Th e la borato ry shall ensure that th e extent ofva lid at io ~
c:7f a1t exam in at ion method is suffi cient to ensure t he validity ofresults pertinent to clinica l dec is io n
~a kin g.
•)
J?mnnnrl wit h thP npprn p rintP ttho -j 11ti n 11 nd c mp t nc~ i h all r i '.rifllw th va lidati n r Htlt
a-nd record wh ether the results meet the sp ecifi ed requirements.
d)
"'V'J hen r hrlngcs are proposed to a va lid ated exa min at ion method, th e clinical imp act sha ll b
._ ·tlvi 'NOd, ond o doc ioion modo oo to •.vh oth or to implement th o modifi ed method.
""r he fo ll owing reco rd s ofval id a tion sh all be r etain d:
:::1)
th vali dat ion procedure used;
zJ spec ifi c requirements for the intended use;
3) determin a tion of the performance specifications of the method;
4) results obtained;
5 J a s tate ment on the validity of the method , de tai ling its fitness for the intended us e.
7.3.4
a)
Evaluation of measurement uncertainty (MU)
The MU of mea sured quantity values shall be evaluated and maintained for its intended use, where
relevant. Th e MU shall be compared against performance specifications and documented.
ISO/TS 20914 provides details on th ese ac tivities together with examples.
b)
Jv1U evaluations shall be regularly reviewed.
c)
for examination procedures where evaluation of MU is not possible or relevant, the rationale for
d)
JV1U information shall be made available to laboratory users on request.
e)
\f\lhen users have inquiries on MU, the laboratory's response shall take into account other sources
of uncertainty, such as, but not limited to biological variation.
f)
If the qualitative result of an examination relies on a test which produces quantitative output data
al1d is specified as positive or negative, based on a threshold, MU in the output quantity shall be
estimated using representative positive and negative samples_
g)
for examinations with qualitative results, MU in intermediate measurement steps or IQC results
which produce quantitative data should also be considered for key (high risk) parts of the process.
h)
]'v1U should be taken into consideration when performing verification or validation of a method,
when relevant.
e,,clusion from MU estim;Jtion shall be documented.
7.3 .5
Biological reference intervals and clinical decision limits
Biological reference intervals and clinical decision limits, when needed for interpretation of examination
resultS, shall be defined and communicated to users.
a)
Biological reference intervals and clinical decision limits shall be defined, and their basis recorded,
to reflect the patient population served by the laboratory, while considering the risk to patients.
NOTE
Biological reference values, provided by the manufacturer can be used by the laboratory, if the
population base of these values is verified and deemed acceptable by the laboratory.
26
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IS/ISO 15189: 2022
b)
Biological reference intervals and clinical decision limits shall be periodically reviewe I, ~tnd ttny
changes communicated to users.
c)
When changes are made to an examination or pre-examination method, the laboratory sh ttl! r ·vi ·w
the impact on associated biological reference intervals and clinical decision limits and corn 1111111 ic- <11t·
to the users when applicable.
d)
For examinations that identify presence or absence of a characteristic, the biological r ·!' •r ' 11 - •
interval io tho choractcriatic to be idmtifi d, t: -t;; - ~ t:llt::LiL ex,.,tJttlttdl.ltlliS.
7.J.G
uocunn:ulctliuu uf e.xmuluallon prut:t:!UUres
a)
The laboratory shall duLUtllelll il~ exaulluallurt procedures to the extent necessary to e M ur • th e
consistent application of its activities and the validity of its results.
b)
Procedures shall be written in a language understood by laboratory personnel and be av il bl in
appropriate locations.
c)
Any abbreviated document content shall correspond to the procedure.
NOTE
Working instructions, flow process diagrams or similar systems that summarize key in form at ion
are acceptable for use as a quick reference at the workbench, provided that a full procedure is av ail bl c for
reference and that the summarized information is updated as needed, concurrently with the full p r cedure
update.
d)
Information from product instructions for use, that contain sufficient information, ca n be
incorporated into procedures by reference.
e)
When the laboratory makes a validated change to an examination procedure which could a ff ct
interpretation of results, the implications of this shall be explained to users.
f)
All documents associated with the examination process shall be subject to document control (s ee
.8_3 _).
7.3.7
Ensuring the validity of examination results
General
7.3.7.1
The laboratory shall have a procedure for monitoring the validity of results. The resulting data shall
be recorded in such a way that trends and shifts are detectable and, where practicable, statistical
techniques shall be applied to review the results. This monitoring shall be planned and reviewed.
Internal quality control (IQC)
7.3.7.2
a)
The laboratory shall have an IQC procedure for monitoring the ongoing validity of examination
results, according to specified criteria, that verifies the attainment of the intended quality and
ensures validity pertinent to clinical decision making.
1)
The intended clinical application of the examination should be considered, as the performance
specifications for the same measurand can differ in different clinical settings.
2)
The procedure should also allow for the detection of either lot-to-lot reagent or calibrator
variation, or both, of the examination method. To enable this, the laboratory procedure should
avoid lot change in IQC material on the same dayjrun as either lot-to-Jot reagent or calibrator
change, or both.
3)
The use of third-party IQC material should be considered, either as an alternative to, or in
addition to, control material supplied by the reagent or instrument manufacturer.
Monitoring of interpretations and opinions can be achieved through regular peer review of
examination results.
NOTE
27
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IS/1 Sc:::J15189 : 202~
b)
....~ e la boratory shall select IQC material th a t is fit for its intended purpose. Wh en se lec ting IQC
t-Jl'lteri al, factors to hP. consiclP.red sh;;!ll inclnd e:
:1-J s tability with regard to the prop erti es of interest;
zl
the matrix is as close as possibl e to th at of pa tient samples;
3) . Lh e lQC material reacts to the examination method in a manner as close as possible to patient
sa mples;
4--J the IQC material provides a clinically relevant challenge to the examination method,
has co ncentration levels at or nea r clini ca l decision limits and when possibl e, covers the
meas urement ra nge of the exam in a tion method.
[{a ppropriate IQC material is not avai lable, the laboratory shall consid er the use of other methods
IQC . Exa mples of such other methods may include:
rar
1.J trend analysis of patient results, e.g. with moving average of patient results, or percentage of
sa mples with results below or above certain values or associated with a diagnosis;
zJ comparison of results for patient samples on a specified schedule to results for patient samples
exa mined by an alternative procedure validated to have its calibration metrologically traceable
to th e same or higher order references as specified in ISO 17511;
3J retesting of retained patient samples.
d)
I QC shall be performed at a frequency that is based on the stability and robustness of the
e~amination method and the risk of harm to the patient from an erroneous result.
e)
"flle resulting data shall be recorded in such a way that trends and shifts are detectable and, where
applicable, statistical techniques shall be applied to review the results.
f)
IQC data shall be reviewed with defined acceptability criteria at regular intervals, and in a
timeframe that allows a meaningful indication of current performance.
g)
Tlle la boratory shall prevent the release of patient results in the event that IQC fails the defined
acceptability criteria.
1) When IQC defined acceptability criteria are not fulfilled and indicate results are likely to
r.ontr1in r.linir.i'lllY ::;ienifirnnt r.rrnr::;, th F. mmlt::; Rhi'111 hF. rF.jr.r.tr,li rmli n:ll':vant patient s<mwles
re-examined after the error has been corrected (see L.S.).
2) The results from patient samples that were examined after the last successful IQC event shall
be evaluated.
7.3.7.3
External quality assessment (EQA)
a)
The laboratory shall monitor its performance of examination methods, by comparison with
results of other laboratories. This includes participation in EQA programmes appropriate to the
ex:aminations and interpretation of examination results, including POCT examination methods .
. b)
The laboratory shall establish a procedure for EQA enrollment, participation and performance for
ex:amination methods used, where such programmes are available.
c)
EQA samples shall be processed by personnel who routinely perform pre-examination, examination,
aod post-examination procedures.
d)
The EQA programme(s) selected by the laboratory shall, to the extent possible:
28
1)
have the effect of checking pre-examination, examination, and post-examination processes;
2)
provide samples that mimic patient samples for clinically relevant challenges;
1
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IS/ISO 15 189 : 2022
3)
e)
fulfii!JSO/IEC 17043 r quireme nts.
When sel ct ing EQA prograrnrne(s), the l<Jboratory should consid r Lh Lype of target vah.u o!'r( •J'ed.
Target values are:
1)
ind ependently set by a refe rence method, or
2)
set by overall con se n. 11 s rlr~t;:1, Cl ncl/or
3)
set by method pe r group consensus data, or
4)
s t by a panel of xp erls.
NOTE 1
When method-ind ependent target valu es are not avai lab l , conse nsus values can b • us •d lo
determine whether deviation s a re labo ratory- or method-specific.
NOTE 2
Where lack of commutab ility of EQA materials can hamper comparison between som m thod s,
it can still be useful for compari sons to be made between method s for which it is commutable, r ath •r th~1 11
relying only on within-method comparisons.
f]
When an EQA programme is either not available, or not considered suitable, the laborato ry shall
use alternative methodologies to monitor examination method performance. The labora tory sha ll
justify the rationale for the chosen alternative and provide evidence of its effectiveness.
NOTE
Acceptable alternatives include:
participation in sample exchanges with other laboratories;
interlaboratory comparisons of the results of the examination of identical IQC materials, which eva lu a tes
individual laboratory IQC results against pooled results from participants using the same IQC materi al;
analysis of a different lot number of the manufacturer's end-user calibrator or the manufact urer's
trueness control material;
analysis of microbiological organisms using split/ blind testing of the same sample by at least two
persons, or on at least two a nalyzers, or hy r~t IP.ast two methods;
analysis of reference materials considered to be commutable with patient samples;
analysis of patient samples from clinical correlation studies;
analysis of materials from cell and tissue repositories.
g)
EQA data shall be reviewed at regular intervals with specified acceptability criteria, in a time frame
which allows for a meaningful indication of current performance.
h)
Where EQA results fall outside specified acceptability criteria, appropriate action shall be taken
(see .82), including an assessment of whether the non-conformance is clinically significant as it
relates to patient samples.
i)
Where it is determined that the impact is clinically significant, a review of patient results that
could have been affected and the need for amendment shall be considered and users advised as
appropriate.
7.3. 7.4
a)
Comparability of examination results
When either different methods or equipment, or both, are used for an examination, and/or the
examination is performed at different sites, a procedure for establishing the comparability of
results for patient samples throughout the clinically significant intervals shall be specified.
NOTE
The use of patient samples when comparing different examination methods can avoid the
difficulties linked to the limited commutability of IQC materials. When patient samples are either not
available or impractical, see all options described for IQC and EQA.
29
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IS/ISO 15189 : 2022
b)
T he laboratory shall record th e res ul ts of co mpa rability perform ed and its accepta bility.
<.:)
T he labo ratory sh all peri odi ca lly r vi w the co mpa rability of r es ults.
cl) \Nhe re differenc es are id enti fied, t he im p ct of tho se differ ences on biolog ica l refe rence intervals
a nd clini cal decision limi ts shall b va lu ate d and acted upon.
e)
Th.: laboratory shall inform use rs
r P.IU lts.
7.4·
Post-examination processes
7 .4.~
7.4.L 1
a)
f
ny clini ca lly significa nt diffe rences in comp a rability of
Reporting of results
General
Examin ation r esults shall be reported accurately, clea rly, una mbiguously and in ac corda nce with
a ny s pecific instruction s in the exa mination procedure. The report shall includ e a ll available
i nform ation necessary for th e interpretation of the results.
b)
The laboratory shall have a procedure to notify users when examination r esults are delayed, based
on t he impact of the delay on the pati ent.
c)
All information associated with iss ued reports shall be retained in accordance with management
s yste m requirements (se e 8.4).
NOTE
For th e purposes of this docum ent, r epor ts can b e iss ued as ha rd copies or by electronic means,
provi ded th at the r equi rements of this docum ent are met.
7.4.1.2
Result review and release
Res ults shall be reviewed a nd auth ori ze d prior to rel ease.
Th e 1a bora tory shall ens ure th at authori ze d personnel review th e results of examinations and evaluate
them. uga ln :l t IQC and, a:l app ro priate, £1Va ll t:tbl e ellhl N1 l ln ftmrtatlon tttt!.l pre vluu!.J e1tull llllullu11 ti:! L UILL.
Responsibilities and procedures for how examination results are released fo r r eporting, including by
whom and to whom, shall be specified.
7.4 .1.3
Critical result reports
When examination results fall within established critical decision limits:
a)
the user or other authorized person is notified as soon as relevant, based on clinical information
available;
b)
actions taken are documented, including date, time, responsible person, person notified, results
conveyed, verification of accuracy of communication, and any difficulties encountered in
notification;
c)
the laboratory shall have an escalation procedure for laboratory personnel when a responsible
person cannot be contacted.
7.4.1.4
Special considerations for results
a)
When agreed with the user, the results may be reported in a simplified way. Any information listed
in 7.4.1.6 and 7.4.:1 .7 that is not reported to the user shall be readily available.
b)
When results are transmitted as a preliminary report, the final report shall always be forwarded
to the user.
30
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IS/ISO 15 189 : 2022
c)
H cords : hill I lw hpt of ~Ill res11ll. whi ·11 a r · provid<·d or:lily, lrl('ltrding d tail of v rifi ·~rt i011 of
occ uril cy of t: Oilllntllril'nt ior1, ;! .<; in 1'/l·. l.:i b). Str ·h r ·~ 11ll s ~ h. ill . liw ~1y s IP followed l.Jy i:l reJ><>I'I.
d)
p <.:i I 'Oil li S ' llirrl~ ll> .ry h · n · 'd d for x. min <ll iorr r<·: tlit s witlr .· ·riotr s implicat ion s fort ll · p::~t i ·nt
(·.g. for I' ·r~ ·ti c or c •rlilin i11f • tious dis 'as s). l. ~llloratory n1arwg 'll1'nt should ensu re t lr ~tl til ·sL!
results ~4 r · 1101 ·orllllltllli ·at ·d to th pali n without tit· oppnrturrity for adequate coun ' llin g.
e)
Res ults of l;;rho n rtory ·xa rnin alion s th at have b · ' n t11ronyrniz ·d m:.1 y b used for such purpos s
piLl ·Jr1iu lu gy, u •JJrugnrplry, ur uth er stt~tlsLlctt l :m tt lys ·s, pt·ovld ed that all risks o palr nt
privacy and co nfid 'ntl alily al" miti •at d a nd in a · <·ord;:~n · with any eith er lega l or 1· · 'lri alory
I'CqUil UIII 'lllH, 01 ' ilot 11 .
1
7.4.1.5
Automated sclcclion, review, re lease and repo1·Ling of results
When th lab ratory imp! ments a syst m for autom ted select ion, review, release and reporting of
results, it shall stab li sh a procedure to ensure that:
a)
the criteria for automated selection, review and release a r specified, approved, readily ava ilabl
and und erstood by personnel responsible for authorizing the rel ease of results;
b)
the criteria are va lid ated and app roved before us e, r gularly reviewed and verified after changes
to the reporting system that ca n affect their proper functioning a nd place patient care at 1·isk;
c)
results selected by an automated reporting sys t m for manual review are identifi ab le; and
as appropriate, date and time of selection and review, as well as identity of the revj ewer are
retrievable;
d)
when neces~ary, rapid suspension of automated selection, review, release and reporting is appli ed.
7.4.1.6
Requirements for reports
Each report shall include the following information, unless t·he lflbnratory has documented reasons for
omitting any items:
a)
unique patient icientifiration, the date of primary sample collection an d the date of the i:.!'!11r nf t·hr
report, on each page of the report;
b)
identification of the laboratory issuing the report;
c)
name or other unique identifier of the user;
d)
type of primary sample and any specific information necessary to describe the sample (e.g. source,
site of specimen, macroscopic description);
e)
clear, unambiguous identification of the examinations performed;
f)
identification of the examination method used, where relevant, including, where possible and
necessary, harmonized (electronic) identification of the measurand and measurement principle;
· NOTE
Logical Observation Identifiers Names and Codes (LOINC) and Nomenclature for Properties and
Units (NPU, NGCl and SNOMED CT are examples of electronic identifici'Jtion.
g)
examination results with, where appropriate, the units of measurement, reported in SI units, units
traceable to SI units, or other applicable units;
h)
biological reference intervals, clinical decision limits, likelihood ratios or diagrams/nomograms
supporting clinical decision limits as necessary;
NOTE
i)
Lists or tables of biological reference intervals can be distributed to users of the laboratory.
identification of examinations undertaken as part of a research or development programme and for
which no specific claims on measurement performance are available;
31
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j)
identification of th e perso n(s) r vi win 1 the results and auth or izin g th r I ase of the report (if not
COi tta in ed in th e report, rea dily nv li able wh en nee ded);
k)
i dentification of a ny res ul ts Lh a l nc d to be considered as prelimin ry;
I)
i ndi cations of a ny critical res ulls;
111) uniq ue identification th at a ll its com ponents are recognized as a portion of
cle<t r id entificatio n of th e end (e.g. page numb er to total numb er of pages).
7 4·1 .7
Arlrlition<~l .
fnr
at" o f · r
omplete r eport and a
port~>
r1)
Wh Pn nPrP<; <;r:~ ry fnr ]1 rl~iPn~ r::1 rP, th P timP of primary 11mple coll ec ti n h II be in cluded.
b)
T int e of report relea se, if not co nt a ined in the r eport, shall be readily ava il able w hen needed.
c)
[ dent ification of all exam in at ions or parts of examinations performed by a referral laboratory,
i ncluding information provid ed by consultants, without alteration, as well as the name of the
I aboratory performing th e examinations.
d)
Wh en app licable, a report sha ll includ e interpretation of results an d comments on:
1 ) sa mple quality and suitab ility that can compromise the clinical valu e of exa mination results;
2) discrepancies when exam inat ions are performed by different procedures (e.g. POCT) or in
different locations;
3 ) possible risk of misinterpretation when different units of measurement are in use regionally or
nationally;
4 ) result trends or significant changes over time.
7.4.1.8
Amendments to reported results
l' r ocedu res tor the issue of amended or revised results shall ensure that:
a)
The rca5on for the change i3 recorded a nd include d in th e r evis ed repo!'t, wh en r eleva nt.
b)
Revised results shall be delivered only in the form of an additional document or data transfer, and
clearly identified as having been revised, and the date and patient's identity in the original report
shall be indicated.
c)
The user is made aware of th e revision.
d)
When it is necessary to issue a completely new report, this shall be uniquely identified and shall
contain a reference and traceability to the original report that it replaces.
e)
When the reporting system cannot capture revisions, a record of such shall be kept.
7.4.2
Post-examination handling of samples
The laboratory shall specify the length of time samples ar:e to be retained following examination and
the conditions under which samples are to be stored.
The laboratory shall ensure that after the examination, the
a)
patient and source identification of the sample are maintained,
b)
suitability of the sample for additional examination is known,
c)
sample is stored in a manner that optimally preserves suitability for additional examination,
d)
sample can be located and retrieved, and
32
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7.5
Noncnn fu nn iug wurl<
Th . l:'lhOJ':'l l()ry : hall hav . ~I j)I'O (' L' .'S for wh ·n r ny [lS jWC l or il .' laborat ory ac tivit i s or xa mi nnLi on
r •s uit s do not ·onfo nn Lo it s own 1 ro ·pdur ' s, (Jtt ::t liLy s p · ·ifi ·:1 Li ons, or Lhe user req ui rem •nt s ( ·.g.
, qui pm •nl or nv ironm •nLa l ·ond ili ons a r CH il of s p · ·ifi ·cl limi ls, r ·s ui ts of moni to rin f i I to 111 ' ·l
sp • ·ifi d ·ri l •ri Ct) . Th • prlJ · •ss sh::lll ·n: 11r ' Lh fi L:
.)
Lh · I' •. pons ibilili •s •tntl auth orili •s fo r Lh • m. n • m nL of non l)nform in wurl · r~ ::.]Je ifi ·d ;
b)
imm etli al • a nd lon g-L •r m a ·Lion : r · s p · ·ifi ·d and b:t: ·d uponlh ri sk analys i processes t;:thli sh ·d
l1y Llll.: I:Jlllll';;l ltH'Y;
c)
·x;11n in aLio ns a r ha lL d, and r rorls w ilhh ld wh n lh rc is
d)
n v Iu- Li on is mad of the clini ca l s igni fica nce of the nonco nfo rmi ng work, in cl ud ing a n impac t
na ly. is on exam inali on r sui ts whi ch w re or co ul d h ve bee n released prior to id entif ica ti on of
the nonco nform ance;
e)
a decis ion is mad on the accepta bili ty of th e nonco nfo rmin g work;
f)
wh en necessary, exa mi nat ion res ults a r revi sed , nd the use r is noti fied;
g)
th respo nsibility for authori zing t he res um ption of work is spec ified.
ri sk of ha rm to pat i nts;
Th e laborato ry shall impl ement corrective act ion co mm en urate w ith th e risk of rec urrenc
non con fo rming work (see li..Z).
f the
The laboratory shall retain records of non co nforming work a nd ac tions as specified in 2..5. a) to g).
7.6
Control of data and information management
7.6.1
General
Th e laboratory shall have access to th e data and inform ation needed to perform laborato ry activities.
NOT E 1
In this docum ent, "laboratory information systems" includes th e management of data and in formation
con tailtt::d iu Lullt cumpuler anti non-computerized systems. Some of th e requirements can be more applica ble to
computer systems th an to non-computeri zed systems.
NOT E 2
Risks associated with computeri zed laboratory information systems are discussed in ISO 22 367:2 020,
A.13.
NOTE 3 The information security controls, strategies and best practices to ensure the preservation of
confidentiality, integrity and availability of information, are listed in ISO/IEC 27001:2022, Annex A Information
security controls reference.
7.6.2
Authorities and responsibilities for information management
The laboratory shall ensure that the authorities and responsibilities for the management of the
information systems are specified, including the maintenance and modification to the information
systems that can affect patient care. The laboratory is ultimately responsible for the laboratory
information systems.
33
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7.6.3
lnformation systems mant1g ·ment
Tlw sy. tem (s) used for th e
II ' I ion, processing, recordin g, r porti tl', s Lor age or retrieval of
ex: t1nination data and inform at ion shall be:
a)
validated by the suppli er a nd verifi ed for functionality by th e labor Lory b fore introduction. Any
changes to the system, including laboratory software configuration or modifi ca tions to commercial
off. t he-shelfsoftware, sha ll be authorized, documented and valid ated b fore implementation;
N O'I' E 1
Valid a ti on and verifi c<t ti on in clude, wh er e applicabl e, the prop er fun ctioning of interfaces
between the laboratory inform ation sys tem and oth er systems such as laboratory quipm ent, hospital
p ali nt admini s tra ti on sys tems nnd sy. te m. in prim a ry ca re.
NOTE 2
Comm er cial off-th e-shelf . oftwar e use d within its des igned appli ca ti on ra nge ca n be considered
s uffi ciently valid at ed (e.g. word process in g a nd spreadsh ee t softwa re, and qu ality manage ment software
prog rams).
b)
documented, and the documentation readily available to authorized users , including that for day to
day functioning of the system;
c)
implemented taking cybersecurity into account, to protect the system from unauthorized access
a nd safeguard data against tamp ering or loss;
d)
operated in an environment that complies with supplier specifications or, in the case of noncomputerized systems, provides conditions which safeguard the accuracy of manual recording and
transcription;
e)
maintained in a manner that ensures the integrity of the data and information and includes the
recording of system failures and the appropriate immediate and corrective actions.
Calculations and data transfers shall be checked in an appropriate and systematic manner.
7.6.4
Downtime plans
The laboratory shall have planned processes to maintain operations in the event of failure or during
ctowntirne in information ~y~tem~ thRt i=lff~r,t:; th~ lr:1hnrr:1tnris nr.tivitiP.s, This inr.halr.s ;mtnmr:ltf.n
selection and reporting of results.
7.6.5
Off site management
When the laboratory information system(s) are managed and maintained off-site or through an
external provider, the laboratory shall ensure that the provider or operator of the system complies with
all applicable requirements of this document.
7.7
Complaints
7.7.1
Process
The laboratory shall have a process for handling complaints that shall include at least the following:
a)
a description of the process for receivmg, substant1atmg and mvest1gatmg the complamt, and
deciding what actions shall be taken in response;
NOTE
The resolution of complaints can lead to implementation of corrective actions (see .8...1.) or be used
as input into the improvement process (seeM).
b)
tracking and recording the complaint, including the actions undertaken to resolve it;
c)
ensuring appropriate action is taken.
A description of the process for handling complaints shall be publicly available.
34
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IS/ISO 15 189 : 2022
7. 7.2
Receipt of complaint
a)
Upon receipt of a complaint, the laboratory shall confirm whether the complaint -. · ·l:lt ·s to
laboratory activities that the laboratory is responsible for and, if so, shall resolve the c ompl ni nt.
(see B2.1).
b)
The laboratory receiving the complaint shall be responsible for gathering all necessary in f 'o n1 1(tt ion
to determine whether the complaint is substantiated.
c)
Whenever possible the laboratory shall acknowledge receipt of the complaint, and pr <> vid ' til '
rnmpl Ain ant with thli' outc ome and, if ::tpplicilLit:J, prugn.n;u rcporta.
7.7.3
Resolution of complaint
Investigation and resolution of complaints shall not result in any discrimin atory actions.
The resolution of complaints shall be made by, or reviewed and approved by, persons not invol"ed in lh
subject of the complaint in question. Where resources do not permit this, any alternative appro ch sl a ll
not compromise impartiality.
7.8
Continuity and emergency preparedness planning
The laboratory shall ensure that risks associated with emergency situations or other conditi ns wh n
laboratory activities are limited, or unava ilable, have been identified, and a coordinated s t rat gy
exists that involves plans, procedures, and technical measures to enable continued operatio n s a ft r
disruption.
Plans shall be periodically tested and the planned response capability exercised, where practi ca bl e.
The laboratory shall:
a)
establish a planned response to emergency situations. taking into account thP. nP ed and capabiliti9s
of all relevant laboratory personnel;
b)
provide intormation and t r a inin g as appropriate to n~l P.v;mt lah or at ory personnel;
c)
respond to actual emergency situations;
d)
take action to prevent or mitigate the consequences of emergency situations, appropriat e to th e
magnitude of the emergency and the potential impact.
NOTE
8
CLSI GP36-A [.3.5.] provides more details.
Management system requirements
8.1
General requirements
8.1.1
General
The laboratory shall establish, document, implement and maintain a management system to support
and demonstrate the consistent fulfilment of the requirements of this document.
As a minimum, the management system of the laboratory shall include the following:
responsibilities (.8...1)
objectives and policies (.8_.2)
documented information (_8.,.2._, .8..3 . and .8....1)
35
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acti ons to address ri sks a nrl npport \1 n iti es for improvement (8~5)
cont inual improvement (0.6)
co1-rective ac ti ons (.8.7)
evalu ations a nd intern a l udi ts (8 .8.)
r:nanagement revi ews (8. )
8.1.2:
Fulfilment Qf management system requirements
Th l ab ora tory may mee t 8.L1 by establi shin g, impl ement in g, and maintaining a quality managemen t
sys tem (e.g. in accordanc e w it h th e requ irements of ISO 9001) (see Iab l '
). This quality managem ent
sys te m hall support and demon st rate th e consistent fulfilment of th e req uirements of Clauses 4 to 2
a nd t he requirements spec ifi ed in 82 to .8.,2.
8. .3
Management system awareness
Th e laboratory shall ensure that persons doing work under the laboratory's control are aware of:
a)
relevant objectives and policies;
b)
their contribution to the effec tiveness of the managem ent system, including the benefits of
improved performance;
c)
the co nsequen ces of not conforming with the management system requirements.
8.2
8.2.1
Management system documentation
General
Laboratory m3mgement sh3ll est3blish, document, and maintain objectives o.nd policies for the
fulfilm ent of th e purposes of this document and shall ensure that the objectives and policies are
aclwowl edgg d and impl &m lilntlil d at alllevtJll!l uf the l c~ Lu rJtu ry vrgJ nizat ion.
NOTE
8.2.2
The management system documents can, but are not required to, be contained in a quality manual.
Competence and quality
The objectives and policies shall address the competence, quality and consistent operation of the
laboratory.
8.2.3
Evidence of commitment
Laboratory management shall provide evidence of commitment to the development and implementation
of the management system and to continually improving its effectiveness.
8.2.4
Documentation
All documentation, processes, systems, and records, related to the fulfilment of the requirements of
this document shall be included in, referenced from, or linked to the management system.
8.2.5
Personnel access
All personnel involved in laboratory activities shall have access to the parts of the management system
documentation and related information that are applicable to their responsibilities.
36
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Con trot of ma nagc m ·n t sys tem do cum 'II s
8.3
8.3.1
f. 11 ·ral
Th · bbor:1 tory : h::1 ll COIIIrolth · don1111 •nls (inl •rn ;1 l, nd ex t •m ;1 l) th at r lat to th e fulfilnP ilL of'thi :
clo ·un1 nl.
NOT!·:
In Lhl s ·nnl •x l, "do ·unl L'II " ·a n b p oli ·y sL; IL ·m e11Ls, pro · •dur sa nd r el at ed j ob aid s, f lo w chart :-;,
in sLru ' LiOII S for !I SC, sr . lfi c;lt itJII S, 1'11 Ci nufa t ur r's lll slru 'lion s, calihralioll ta bl es, biol ogi ca l r efcr enc . inl ' rv :'l ls
<111rlltlf' lr llrini n ·, r·h·tn ·, po·t r ·, Ill Lit; r., n10m ornndn , r.n fl'\·v nr o tl noum o11 t nti on1 d1•ow in go, plu11n,ug 1'U •n1 ' IIL:r,
and d oc ulu t' nl s o f t!x l r' rn al ori g iJ1 su ·h as b w s, r ·gul <lliOni;, s Ulllcl nrds and t extb ook s fro m w hi ch ex. nllill;ill ll n
me th od: an• t al •n, d t:ll lll ·nls d •sr ri lJ i ng p •rso n ncl quali flc::tlions (s uch ' I S job descr i ptions), etc. Th cs · t:01 11 b ' Ill
any fo rm J' l YI L of n L d il lll , . H i t .1. 11 . 11
u py u 1 Lli g it.Ji .
u
8.3.2
Contt·ol of docum e nts
Th e la horatory s ha ll ens ur th a t:
a)
do cum ents a re uniqu ely id entifi ed;
b)
do cum ents are approved for adequacy be for e iss ue by authori z d personnel who have th e e xp "rti s ·
nd competenc to determin e adequ acy;
c)
do cum ents a re periodi ca lly revi ew d and upd a ted as necessa ry;
d)
r eleva nt vers ions of applica bl e docum ents are ava il abl e at points of us e a nd, where necessa ry, th ir
di s tribution is controll ed;
e)
changes and th e current r evi s ion status of docum ents are id entifi ed;
f)
documents are protected from unauthorized changes and any deletion or removal;
g)
docum ents are protected from unauthorized access;
hj
th e unintended use ot obsolete documents is prevented, and suitable identification is appli ed to
them if they are retained for any purpose;
i)
at least one paper or electronic copy of each obsolete controlled document is retained for a specified
time period or in accordance with applicable specified requirements.
8.4 Control of records
8.4.1
Creation of records
The laboratory shall establish and retain legible records to demonstrate fulfilment of the requirements
of this document.
Records shall be created at the time each activity that affects the quality of an examination is performed.
NOTE
8.4.2
Records can be in any form or type of medium.
Amendment of records
The laboratory shall ensure that amendments to records can be traced to previous versions or to
original observations. Both the original and amended data and files shall be kept, including the date and
where relevant, the time, of alteration, an indication of the altered aspects and the personnel making
the alterations.
37
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8.4.3
Retention of records
a)
"Tht• laboratory shall irnpl 11 1 ,n t t h procedures nee ded for t he id nt·ifi ·a tion, s to rage, protection
from unauthori zed ace ss a nd ·!t a ng s, back-up, archive, retri eval, r L nLion time, and disposal of
its records.
b)
"The retention tim es for r cord s s hall be specified .
NOTE 1
In addition to rcquircm nL , retenliun Limes ca n be chosen ba:; ecl on icl en lifi ecl ri:;le,;.
Reported exam in at ion r s ui ts sh all be retrievable for as lon g as ne cessary or as required.
d)
A llt·ecords sha ll be acc essibl throughout the ent ire retention period, I gible in wh ichever medium
t he laboratory keep s record s, a nd available for laboratory mana ge ment rev iew (see .8.3.).
NOTE 2 Legal li ab ility concern s regard in g certa in types of procedures (e.g. hi s tology exami na ti ons, genetic
exantinations, pediatric exa min ations) ca n require th e retention of certain records for mu ch longer times than
for ot her records.
Actions to address rish:s and opportunities for improvement
8.5
8.5. ~
Identification of risks and opportunities for improvement
Th e lab oratory shall identify risks and opportunities for improvem ent assoc iated with the laboratory
activiti s to:
a)
prevent or reduce unde sired impacts and potential failure s in the laboratory activities;
b)
achieve improvement, by acting on opportunities;
c)
assure that the management system achieves its intended results;
d)
m it igate risks to patient care;
e)
help achieve the purpose and objectives of the laboratory.
H.5.Z
Acting on risks and opportunities for improvement
Th e laboratory shall prioritize and act on identified risks. Actions taken to address risks shall be
proportional to the potential impact on laboratory examination results, as well as patient and personnel
safety.
Th e laboratory shall record decisions made and actions taken on risks and opportunities.
The laboratory shall integrate and implement actions on identified risks and improvement opportunities
into its management system and evaluate their effectiveness.
NOTE 1
Options to address risks can include identifying and avoiding threats, eliminating a risk source,
reducing the likelihood or consequences of a risk, transferring a risk, taking a risk in order to pursue an
opportunity for improvement, or accepting risk by informed decision.
NOTE 2 Although this document requires that the laboratory identifies and addresses risks, there is no
requirement for any particular risk management method. Laboratories can use ISO 22367 and ISO 35001 for
guidance. ·
NOTE 3
Opportunities for improvement can lead to expanding the scope of the laboratory activities, applying
new technology, or creating other possibilities to fulfil patient and user needs.
38
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8.6
lmpmv 'Ill ·nt
8.6.1
Continual impmv 111 ·nt
)
Th J l::tl )() ralory : hnll 'tl lttilllt :'l ll y in1prov th · •f'f • ·tiv VIH'.'S of til · ma na •ement sysl>n f, tll('ltulill~
th · pr •- • x <tlllin ;;~ llon, 'X<J nlin alion t1nd post- •xa nlin ati on proc •ss s as slated in th obj • · tivrs ~1nd
1 oli ·i ~ s.
b)
Th ·l aboratory sh;,ll icl•fltify a nd s I ct OPI of'l'un iti ·s for improveme nt a nd d velop, docurn ·nL,
a nd irnpli:nwnt c ny nrr·f• · ';J ry act ion s. lmprov ·nP nl r~c tiviti ·s shell! be direc ted at a r as o f hi gh sl
priorit bas ed on risk assPss nwnls ancll h opport unit il'S iciPntifi •cl (.' 8.5).
NOTE
Opporluni ti 'S for imp roveme nt can be iu ' nlifi ecJ through risk assessm ent, use of th po li ·i •s,
r •vi •w oflh · op ·r liu n<J l pro cedures, overa ll objcctiv •s, •xl •rn. I cv, lu , tion r ports, interna l audit fi nd ings,
·omp l<J inls, c rrcctive act ion s, ma nage ment revi ·ws, s ugg ·.~lions from personne l, s uggestions 01· f • •dba I<
fro111 palicnts a nd use rs, a nalys is of data a nd EQ/\ res ul ts .
c)
Th laborato ry sha ll valu ate the effectiven ss of the ac lions taken .
d)
Laboratory management shall ensure that th labor to ry participates in continual improv m nt
act ivi t ies that encompass rel evant areas and outcom s of pati ent care.
e)
Laboratory manageme nt shall comm uni cate top rsonnel its improvement plans and r lated goa ls.
8.6.2
Laborato1·y patients, user, and personnel feedback
The laboratory shall seek feedback from its patients, users, and personnel. The feedback shall be
ana lyzed and used to improve the management system, laboratory act ivities and servi ces to us rs.
Records of feedbac k shall b maintained including th e act ions taken. Communication shall be provid ed
to personnel on act ions taken arising from their feedback.
8.7
Nonconformities and corrective actions
H.'/ .1
Actions when noncontormity occurs
When a nonconformity occurs, the laboratory shall:
a)
Respond to the nonconformity and, as applicable:
l)
ta ke immediate action to control and correct the nonconformity;
2)
address the consequences, with a particular focus on patient safety including escalation to the
appropriate person.
b)
Determine the cause(s) of the nonconformity.
c)
Evaluate the need for corrective action to eliminate the cause(s) of the nonconformity, in order to
reduce the likelihood of recurrence or occurrence elsewhere, by:
1)
reviewing and analyzing the nonconformity;
2)
determining whether similar nonconformities exist, or could potentially occur;
3) assessing the potential risk(s) and effect(s) if the nonconformity recurs.
d)
Implement any action needed.
e)
Review and evaluate the effectiveness of any corrective action taken.
f)
Update risks and opportunities for improvement, as needed.
39
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g)
Make changes to th e ma nagem ntsystem, ifnecessary.
8-7.2
Corrective action effective ness
Cnrf~ e ct ive actions sha ll b appropri ate to th e effects of th e non co nformiti es ncountered and shall
mitigate the id enti fied ca use(s).
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Th ' l ab ratory shall reta in reco rd s as ev idence of the
a)
nature of the nonconformiti es, ca use (s) and any subsequent acti ns L k n, a nd
. b)
evaluation of the effectivene s of a ny corrective actio n.
8.8
Evaluations
8.8.1
General
Th laboratory shall conduct eva luat ions at planned intervals to demonstrate that the management,
supp ort, and pre-exam in ati on, exam ination, and post-examination processes meet the needs and
r qujrements of patients a nd laboratory users, and to ensure conformity to th e r equirements of this
doCLtment.
8.8.2
Quality indicators
Th e process of monitorin g quality indicators [see 5.,1i d)] shall be planned, which includes establishing
t he obj ectives, methodology, interpretation, limits, action plan a nd duration of monitoring. The
indic ators shall be periodically revi ewed, to ensure continued appropriateness.
8.8.3
Internal audits
8.8.3.1 The laboratory shall conduct internal audits at planned intervals to provide information on
whether the managemenL syslern
a)
conforms to the laboratory's own requirements for its management system, including the
laboratory activities,
b)
conforms to the requirements of this document, and
c)
is effectively implemented and maintained.
8.8.3.2 The laboratory shall plan, establish, implement and maintain an internal audit programme
that includes:
a)
priority given to risk to patients from laboratory activities;
b)
a schedule which takes into consideration identified risks; the outcomes ofboth external evaluations
and previous internal audits; the occurrence of nonconformities, incidents, and complaints; and
changes affecting the laboratory activities;
c)
specified audit objectives, criteria and scope for each audit;
d)
selection of auditors who are trained, qualified and authorized to assess the performance of the
laboratory's management system, and, whenever resources permit, are independent of the activity
to be audited;
e)
ensuring objectivity and impartiality of the audit process;
40
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IS/ISO 15 189 : 2022
f)
ensuring that the results of the audits are reported to relevant personnel;
g)
impl emen tatiu11 uf aJJJJI'UJJriale correction ami corrective actions without undue delay;
h)
retention of records as evidence of the implementation of the audit programme and audit r ·; ult .".
NOTE
8.9.1
ISO 19011 provides guidance for auditing management systems.
General
Labora to ry man agement shall review its management system a t planned intervals to e nsu r-> its
continuing suitability, adequacy and effectiveness, including the s tated policies and obj ectiv s r IRL ·d
to the fulfilment of this document.
8.9.2
Review input
The inputs to management review shall be recorded and shall include evaluations of at le st the
following:
a)
status of actions from previous management reviews, internal and external changes to th
management system, changes in the volume and type of laboratory activities and ad eq uacy of
resources;
b)
fulfilment of objectives and suitability of policies and procedures;
c)
outcomes of recent evaluations, process monitoring using quality indicators, interna l aud its,
analysis of non-conformities, corrective actions, assessments by external bodies;
d)
patient, user and personnel feedback and complaints;
e)
quality assurance of result validity;
f)
efft! LLI Vt!llt:!~~ uf CI IIY illllJlerrH!t1ted l tft }:H'bVe tft eflt~ ahd actions taken to address ris ks a nd
opportunities for improvement;
g)
performance of external providers;
h)
results of participation in interlaboratory comparison programmes;
i)
evaluation of POCT activities;
j)
other relevant factors, such as monitoring activities and training.
8.9.3
Review output
The output from the management review shall be a record of decisions and actions related to at least:
a)
the effectiveness of the management system and its processes;
b)
improvement of the laboratory activities related to the fulfilment of the requirements of this
document;
c)
provision of required resources;
d)
improvement of services to patients and users;
e)
any need for change.
Laboratory management shall ensure that actions arising from management review are completed
within a specified time frame.
41
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IS/ISO 15189: 2022
f)
en _;u ring t hat the results of the audits are reported t o rel>:!vant personnel;
g)
impleme ntation of appropriate correction and corrective actions without undue delay;
h)
retention of records as evidence of th e implementaticn of the audit programme and audit results.
:\O:' E
ISO 19011 provides guidance for auditing management systems.
l\fanagement reviews
8.<Jl
8.9 .1
General
La bon:ory management shall review its management system at planned intervals to ensure its
cor:t irming su itability, adequacy and effectiveness, including the stated policies and objectives related
to the fu lfil ment of this document.
8 .9.2
Review input
The inpu;:s to management review shall be recorded a nd shall include evaluations of at least the
'olin wing:
a)
strt us o f ac t ion s from previou s management rev iews, internal and external changes to the
man agement system, changes in th e volume and type :Jf labora tory activities and adequacy of
r eso urces;
b)
~ll:iilment of objectives and suitability of policies and pro:edures;
c)
outcomes of recent evaluations, process monitori ng tLSing quality indicators, internal audits,
ar al vsis of non -conformities, corrective actions, assessments by external bodies;
d)
pc.ti ent, user and personnel feedback and complaints;
e)
qLa licy assurance of res ult validity;
f)
ef:ectiveness of any implemented improvements an d actions taken to address risks and
Oj: pon u nit ies for improvement;
g)
pErformance of external providers;
h)
results of participatio n in interl aborato ry comparison programmes;
i)
evc.lua tion ofPO CT activities;
j)
other relevant factors, such as monitoring activities and tr aining.
8.9.3
Review output
The OLtput from t he management revi ew shall be a recorc of decisions and actions related to at least:
a)
th =. effectiveness of the management system and its p::-ocesses;
b)
irr.pr ovement of the laboratory activities related tc the fulfilment of the requirements of this
dacum ent;
c)
previs ion of required resources;
d)
improvement of services to patients and users;
e)
any need for change.
Lab orc.tory managem ent shall ensure that actions arising from management review are completed
wit hin;;~ s o ec ified t imQ fr::~mQ.
41
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_T.s! E ~
IS/ISO 15189: 2022
Conclusions and actions arisi ng fro m management reviews shall be commun icated to l.abor:non·
personnel.
42
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IS/ISO 15189 : 2022
AnnexA
(normati11e)
Additional requirements for Point-of-Care Testing (POCT)
A.l General
Thr.o annex describe s the additional requirements for the laboratory for POCT that are distinct
fro :'ll, or in addition to, those outlined in the main text. Thes·e requirements specify the laboratory's
res;:> onsibil ities towards organizations, departments a1d the-ir personnel regarding the selection of
d8--J ces, trainin g of personnel, quality assurance, and the management review of the complete POCT
prcr:ess.
Par ent self-testing is excluded, but elements of this doc c:ment :nay be applicable.
NO'":"' E 1
ISO/TS 22583 provides guidance fo r non-laboratory supported services.
·o-:-E 2
ISO 15190 and ISO 2236 7 provid e guidance on safEty and risk aspects ofPOCT.
A.:
Governance
ThE governing body of th e organization shall be ultim<Iely responsible for ensuring that appropriate
processes are in place to monitor the accuracy and qual i:ty of POCT conducted within the organization.
Ser;i ce agreements between th e laboratory and all locations using laboratory supported POCT shall
e rr~ re that respecti ve responsibilities and authoritie:: are s:pecified and communicated within the
org3n izatio n.
ThEs e agreeme nts shall have clinical approval, and where applkable, financial approval.
ThEs e service agreements shall be with POCT areas a:Jd may be managed via a health professional
grc uping (e.g. medical advisory committee).
A.:: Quality assurance programme
ThE laborato ry shall appoint a person w ith appropriatE train ing and experience to be responsible for
PO :T qu ality, which includes review of and conform icy w ith the requirements of this document as
r clcted to POCT.
A A· Training programme
A 1=erson wi th appropriate trammg and experience .shall be appointed to manage training and
w n petency assessment of personnel performing PO CT.
ThE train er shall develop, implement, and maintain an :appro::J riate theoretical and practical training
prc·s ramrn e fo r all POCT personnel.
43
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IS/ISO 15189: 2022
Annex B
(informative)
Comparison between ISO 900 1 :2015 and ISO 15189:2022 (this
document)
ISO 9001 is part of the ISO 9000 family of quality management standards and specifies requirements for
a quality management system. Table 8.1 illustrates the concep tual relati onship between this doc ument
and ISO 9001:2015.
The format of this edition of this document more cl osely resembles that ofiSO/IE C 17025:2017, which is
used as the model for the structure of this document with specific adjustment for med ical laboratories.
Table 8.2 shows the comparison between these two documents.
Table B.1- Comparison between ISO 9001:2015 and this document
ISO 9001:2015
4 Context of the organization
ISO 15189:2022 (this document)
1 Scope
2. Normative references
.3. Terms and definiti on s
1 General requirements
4.1 Understanding the organization and its context
U lmp artiality
1 Scope
2. Normative references
3 Terms and definitions
4.2 Understanding the needs and expectations of inter- 1..2. Confidentiali ty
ested parties
4:.2..1 Management of information
4.3 Determining the scope of the quality management
4.2.2 Rel ease of information
system
4.2.3 Personnel responsibi lity
4.4 Quality management system and its processes
4.3. Requirements regarding patients
.5....1 Legal entity
.8. Management system requirements
.8..1 General requirements
5 Leadership
.8....ll General
.5. Structural and governance requi rements
5.1 Leadership and commitment
.52. Laboratory director
5.1.1 General
.5.2..,1 Laboratory director competence
5.1.2 Customer focus
52.2. Laboratory director responsibi litie s
5.2 Policy
.5....2..3. Delegation of duties
5.2.1 Establishing the quality policy
.5.3. Laboratory activities
5.2.2 Communicating the quality policy
5.3.1 General
5.3 Organizational roles, responsibilities and authorities
.5....32 Conformance with requirements
.5...3.3. Advisory activities
SA Structu re and authority
5A:.1 General
5A2 Quality management
44
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83 25213<1- da:eo ~024 18 37:00 agai!Ei B I S-2024082~4
IS/ISO 151 89 : 2022
Table B.l (continueC)
ISO 15189:2022 (this document)
ISO 9001:2015
6 -=>Ia1ning
6. _ A:tion s to address risks and opportunities
6 ..=! Quality objectives and planning to achieve them
6.3 p· anning of changes
.8.....5. Actions to address risks and opportunities for
improverr.ent
.8.....5...1 Ider_t ification of risks and opportunities for
improverr..ent
.8....5.....2. Acting on risks and opportunities for improvement
.5.5 Objec::ives and policies
.5.& Risk rr.anagement
z...a Conti nuity and emergency pre paredness plan ruing
7 :;Lq:Jport
.6 Resourc:: requirements
7.1 Resources
7. 1.~ -=>eople
.6....1 Gener3.1
.6...2. Perso::mel
.6....2....1 General
7.1. 3 n frastructure
.6.....2...2. Con:.petence requirements
7.1...; Environm ent for the operation of processes
.6..2....3. Authorization
7.1.5 ;foni toring and measur ing resources
.6....2...1: Con ti nuing education and professional develop-
7.1. 6 Organizational k nowl edge
ment
1.1.1 General
.62..5. Personnel records
.6....3. Facilities and environmental con dit ions
.6....3...1 General
.6....3...2. Faci lty controls
~ Sto n ge facilities
.6....3...1 Persnnnel facilities
~ Sample collection facilities
7.2 Campetence
.6.....2...2. Competence requirements
73 ....wareness
.8....1.3 Man =.gement system awareness
2..6 Contrc ~ of data and information management
7.4 Com munication
2..6.1 GenE!ral
1&.2. Autlrorities and responsibilities for information
management
l...6..3 1nformation systems management
2..6.A Dowr.time plans
2..6,5 Off st: e management
45
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IS/ISO 15189: 2022
Table B.l (continued)
IS O 15189:2022 (this document)
ISO 9001:2015
7.5 Document ed information
.8...2. Management system documentation
7.5.1 General
l1.U General
7.5.2 Creating and updating
.8.2.2. Competence and quality
7.5.3 Control of documented information
8..l..:i Evidence of commitment
.8..2.A Documentation
8.2.5. Person nel access
U Control of management system documents
all General
.8.32 Control of documents
M Control of records
.8...il Creation of records
8.4.2 Amendment of records
8 Operation
.8.A3 Retention of records
M Equipment
8.1 Operational planning and control
.6.A.1 General
M2 Equipment requirements
.6A.1 Equipment acceptance procedure
6.4..4 Equipment instructions for use
.6...±...5. Equipment maintenance and repair
.6..±..6 Equipment adverse incident rep orting
.6.A.l Equipment records
.6...5. Equipment calibration and metrological traceability
Q..5J. General
Q.5.2 Equipment calibration
8.2 Requirement ~ for products and services
.6...5...3. Metrological traceability of measurement resuli:s
M Reagents and Consumables
8.2.1 Customer communicat ion
.6.&..1 Reagents and consumables - General
8.2.2 Determining the requirements for products and
services
.Q.Q2 Reagents and consumables - Receipt and storage
8.2.3 Review of the requirements for products and
services
.6..M Reagents and consumables- Inventory management
8.2.4 Changes t o re quirements for products and services
6Ji...5. Reagents and consumables - Instructions for use
.6....6.....3. Reagents and consumables - Acceptance testing
.6..QJl Reagents and consumables - Adverse inc iden t
reporting
6..fJ...1 Reagents and consumables - Records
QJl Externally provided products and sen·ices
6JL1 General
.6.JL2. Referral laboratories and consultants
6.J11 Review and approval of externally provided
products and services
46
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IS/ISO 15189 : 2022
Table B.l [continueCl]
E.3 ~sign and deYelopment of products and services
I
ISO 15189:2022 (this document)
1 Process requirements
E.3.1 General
l l General
E.3.2 Design and development planning
l l Pre-e:.ea mination processes
E.3.3 Design and developm ent inputs
Z2...l GenEral
E.3.4 Design and development controls
1.22 Labcratory information for patients and user.s
fi.3.5 Design and de\·elopment outputs
1...2...3 Requests for providing laboratory examinati•J ns
11.3.6 Design and development changes
7.2.3 .1 Ge1eral
ISO 9001:2015
7.2.3.2 On! requests
7.2.4 Pri mary sample collection and handling
7.2.4.1 General
.2...2...4...2. In:'Drmation for pre-collection activities
2.2.....1:3. Pat ient consent
7.? .4.4 Instructions for collection activities
7,2,5 Sam[Jle transportation
l..1...Ji Samp le receipt
7.2 .6.1 Sample receipt procedure
l..2...f:h1. Sample acceptance exceptions
221. Pre-,examination handling, preparation and
stnrage
1..2...1.1 Saople protection
7,2 7 2 Cr l ~ eria for additional examination request::;
7...2.:J..3. Sa mple stability
8A- Cont~ol of externally provided processes, pro ducts
and S?n."Jces
a.-H General
a.-:-.2 Type and extent of control
8...-:-.3 Inform ation for external providers
jhl Servic= agreements
c. =>
J..!.&
Exter:Ja II y prov1.d e d pro ducts an d services
.
.6.3.1 General
.6....82 Referral laboratories and consultants
.6....,3.3 Revi.=w and approval of externally provided
products and services
8...5 Production and service provision
2..3. Exami:Jation processes
8.5.1 Control of production and service provi sion
2ll General
8. 5.2 Jdentification and traceabi lity
.z.ll Veri fi cation of examination methods
8.5.3 Property belonging to customers or external
provders
Ll.1 Validation of examination methods
8 .. 5.4 Preser\'ation
1...3..5 Biolcgical reference intervals and clinical dedsion limit!::
8.S.5 ?osc-d elivery activities
UJl Docurrnentation of examination procedures
8.5.6 Co nrrol of changes
2!:2.. Post--examination handling of samples
47
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IS/ISO 15189 : 2022
Table R.1 (co ntinued)
ISO 9001:2015
8.6 Release of products and services
ISO 15189:2022 (this document)
7.4 Pos t- examination processes
7.4.1 Reporting of results
7.4.1.1 General
7.4.1.2 Result review and release
1.1...L3. Cr itica l result reports
2..4..1...1 Spe cial co nsiderat ions for results
7.4.1.5 Automated selection, review, release andreporting of res ults
1.1..1...6 Requirements fo r repor ts
7.4.1 7 Additonal in form ation for reports
8.7 Control of nonconforming outputs
9 Performance evaluation
lA:..l.Jl Amendments t o report ed res ults
2..5_ Nonconforming work
l...3.A: Evaluation of measurement uncert ainty
9.1 Monitoring, measurement, analysis and evaluaticlil 7. 3.7 Ensuring the validity of exa minati on r esults
9.1.1 General
7.3.7.1 General
9.1.2 Customer satisfaction
7.3.7.2 Internal quality control (IQC)
9.1.3 Analysis and evaluation
7. 3.7.3 External quality assessment (EQA)
7. 3.7.4 Comparability of exa min ati on r esults
9.2 Internal audit
.8Jl. Evaluations
.8.JL1 General
BJL2. Quality indicators
B.J1..3. Internal audits
9.3 Management review
.8.,2 Management reviews
9.3.1 General
all General
9.3.2 Management review inputs
.8..,2,2. Review input
9.3.3 Management review outputs
.8.,2,_3_ Review output
10 Improvement
B~6 Improvement
10.1 General
.8.....6...2. Laboratory pat ients, us er and personnel feedback
10.2 Nonconformity and corrective action
1,_5_ Nonconforming work
21. Complaints
7.7.1 Pro cess
7.7.2 Re ceipt of complaint
7.7.3 Res olution of complaint
B..2 Nonc onformities and corrective actions
B..2.1 Actions wh en nonconformity occurs
all Corrective action effe ctiveness
10.3 Continual improvement
48
B.23. Records of nonconformities and cor r ective actions
.8..&,_1 Continual improvement
!
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IS/ISO 15189
2022
Table B.2- Comparison between ISO/IEC 17025:2017 and this document
ISO 15189:2022 (this document)
ISO/IEC 17025:2017
1. Sc::>pe
~
Normative references
1 Scope
2. Normat ive references
4 1 I::npartiality
.3. Terms a nd definitions
.:!: General requirements
.:!:.J. Impar tiality
-!- 2 Confidentiality
.42. Confidentiality
3 T~m s and definitions
-!-. GEneral requi rements
12....1 Management of information
.1.2...2. Release of information
.£Z.3. Personnel responsibility
5 St-uctural requirements
:L.3. Requjrements regarding patients
5 Structural and governa nce requirements
.5...1 Legal Entity
5..2. Labor atory director
.5..2.,.1 Laboratory director competence
.5...2....2. Laboratory director responsibilities
.5..2....3. Delegation of duties
.5.....3. Laboratory activities
.5.....3..1 Scop e of laboratory activities
.53..2. Conformance with requirements
.5.....3..,..3. Advisory activities
.5...:!: Struct ure and authority
.5A..1 General
.5..1.2. Qual ity management
.5...5_ Objectives and policies
.5..6 Risk management
6 Resource re quiremen ts
.Q Resource requirements
t) 1 Ceneral
hl Gener al
ti 2 Fersonnel
.62 Personnel
.62.1 General
.6.2..2. Competence r equ irements
.6..2..3. Auth orization
.6....2...1 Cor.tinuing education and professional devekl pment
6.3 Faciliti es and environmental conditions:
.62...5. Personnel records
.6.3. Facilities and environmental conditions
.6,ll Genera!
.6....3..2. Facility controls
.6....3....3. Storage facilities
.6...3..:!: Personnel facilities
.6.3.5 Sample collection facili ties
49
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IP address 203.189.252.130 - da::e<l2310812024 18-37:00 aga) lSt S.tS-202~
IS/ISO 15189 : 2022
Table B. 2 (continued)
ISOfiEC 17025:2017
6.4 Equipment
ISO 15189:2022 (this document)
M Equipment
.6A:,l General
.6A.2. Equipment requirements
.6A..J Equ ipment acceptance procedure
.6..1:.1 Equipment instructions for use
.6A.5 Equipment maintenance and repair
.6A:,_6_ Equipment adverse incident reporting
6.4.7 Equipment records
6.5 Metrological traceability
.6.,_5_ Equipment calibration and metrological traceabil-
ity
.6~5.1. General
~E quipment calibration
6.6 Externally provided products and services
.6..5..1 Metrological traceability of measurement resu lts
M Reagents and Consumables
QJi,1 General
.6_._62 Reagents and consumables - Receipt and storage
M,3. Reagents and consumables - Accep~:ance testing
tiJlA: Reagents and consumables - Inventory management
.6.&,_5_ Reagents and consumables - Instructions for use
fiJiJi Reagents and consumables - Adverse incident
reporting
6.6.7 Reagents and consumables - Records
fiJ_ Service agreements
6.7,1 Agreements with laboratory users
6.7,2 Agreements with POCT users
6.Jl. Externally prov ided products and sen·ices
6_._8_._1 General
6J32 Referral laboratories and consulta nts
.6..JL3. Review and approval of externally pro\' ided
products and services
7. Process requirements
50
2 Process requirements
· .=a~) ;sB E<!!;e mo.,- d>e license
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IS/ISO 151 89 : 2022
Table B.2 (continued)
ISO 15189:2022 (this document)
ISO/ IEC 17025:2017
- .J. Review of requests, tenders and contracts
l l General
'L1.. Pre-e:;:amination processes
l.L1 General
'Ll..2. Laboratory information for patients and use:-s
l.Z.,1 Requests for providing laboratory examinat:ons
.7.2...3..1 General
7.2.3.2 Oral requests
7.2.4 Primary sa mple collection and handling
7.2 4.1 General
7.2.4.2 In formation for pre-collection activities
1.2....4..1 Partient consent
7. 2.4.4 Instructions for collection activities
7.2.5 Sample transportation
22.fJ. Sample receipt
.l,l&,1 Sample receipt procedure
22.J22 Sample acceptance exceptions
l.2..J... Pre-examination handling, preparation and
storage
l.2..21 Sample protection
7.2.7 2 Criteria fo r additional examination request s
22..J..,3_ Sample stability
-::z Scelecrion, verification and va li da t io n of methods
13. Examination processes
-::.z.l Selection and verification of methods
2.3...1 General
1..32 Verification of examination methods
-::z. Z Validation of method s
1...3....3. Val dation of examination methods
1..3..5 Biological reference intervals and clinical decisian limits
- .3 Sampling
A!- andling oftest or calibration items
7:5 Technical records
See U
M...2. Post-examination handling of samples
.l.2.A:A e) Instructions for collection activities
2.ll.d) Examination processes- General
, ;0 E....-aluarion of measurement uncertainty
' -' Ensuring the \·alidity of results
.I.1:.1J3. Amendments to reported results
2.3A Evaluation of measurement uncertainty
23.1. En suring the validity of examination results
.2.3.7.1 General
7.3.7.2 Internal quality control (IQC)
J..:J.:Z.:3. External quality assessment (EQA)
2..3....l..4 Com parability of examination results
51
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ro:->' -
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IS/ISO 15189 : 2022
Table B.2 {continued)
ISO/IEC 17025:2017
7.8 Reporting of results
ISO 15189:2022 (thi s document)
M Post-examination processes
T
2ll Reporting of results
21:..Ll General
lA:.l.2. Result review and release
1..1.1._5_ Automate d selection, revie\\', release and re-
porting of results
7.8.1 General
Mll General
7.8.2 Common requirements for reports (test, calibration or sampling)
1.1.1._6_ Requirements for reports
7.8.3 Specific requirements for test reports
7.8.4 Specific requirements for calibration certificates
7.8.5 Reporting sampling- specific r equirements
ll1.1 Additonal information for reports
lA:.1..l Critical result reports
7.4.1.4 Spec ial considerations for results
~ Amendments to reported results
7.8.6 Reporting statements of confor:nity
7.8.7 Reporting opinions and interpretations
7.8.8 Amendments to reports
7.9 Complaints
7.7 Complaints
7.7.1 Process
7.7.2 Receipt of complaint
7.7.3 Resolution of complaint
7.10 Nonconforming work
7..5_ Nonconforming work
7.11 Control of data and information management
1& Control of data and information management
7.6.1 General
1..62. Auth orities and responsibilities for information
manageme nt
1&,_3_ Information systems management
L.QA Dow ntime plans
Zhl Off site management
1._8_ Continuity and emergency preparedness planni ng
8. Management system requirements
_8_ Management sys tem requirements
8.1 Options
_8__.1 General requirements
8.1.1 General
_8__.1.1 General
8.1.2 Option A
_8_,_12 Fulfilment of management system requirements
8.1.3 Option B
.8..1..3_ Management system awareness
8.2 Management system documentation (Option A)
_8_,2_ Management system documentation
B.,ll General
_8_22 Competence and quality
.a.2,.J Evidence of commitment
B..l..4 Documentation
_8__.2.5_ Personnel access
8.3 Control of management system documents
(Option A)
_8_3 Control of management system documents
_8_._ll Gen eral
fL32 Control of documents
52
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" aooress 203.11>9 252.13o!l- da:eo 2310812024 18:37:10 qa:-st BIS-20240823-44
IS/ISO 15189 : 2022
Table 8.2 (conlinue-:1)
ISO 1 5189 :202 2 (this document)
ISO/ IE C 17025:2017
3.4 Control of records (Op tion A)
M Comt::-nl of records
B.A:..:. Cre.ation of records
~ A me ndment of records
3 .!: fi ctions t o address risks and opportunities
:opoon A)
B...4:..:l Retention of records
B...S .d.Ctic:Js to address risks and opportun ities fo r
imp::-ovec1 ent
B.5...:. Idell!t ification of risks and opportunities for
imp ::- o ve ~1en t
.8....5..:. Act:ng on risks and opportunities for impro• ement
3.E Improvement (Opt ion A)
.
::3.7 Corrective actions (Option A)
.8.....6. Iinprovement
.8Jl..:. Continual improvement
~ LabJ:Jratory patients, user and pers onnel fedback
B..1 Llonam fo rm ities a nd corrective act ion
.8...Z..1 Acti::ms when nonconformit y occurs
i
I
8. 7.:C CDrrective acti on effectiveness
I
8.7. :: Records ofnonconformit ies and corrective actio n.:;
.3..E Internal au dits (Option A)
.8J3. I:vall!l3tions
I
.8.J:L:.. Ge liE r a I
i
~Qu al ity indicators
~ Imt8'na l audits
8 .3 Management reviews (Option A)
.8...2 trfanagement reviews
El2...1 G ~neral
.8...2.k R.e\•:ew input
~ REv:ew output
53
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IP adctess 203 189.252.130 - da:ed 2:wa/202 ~ 18'37.00 &JP..:ns·~ E •S-202~
IS/ISO 15189 : 2022
AnnexC
(informative)
Comparison between ISO 15189:2012 and ISO 15189:2022 (this
document)
Table C.1- Comparison between ISO 15189:2012 and ISO 15189:2022 (this document)
ISO 15189:Z012
ISO 15189:2022 (th is document)
,
Foreword
Foreword
Introduction
Introduction
1 Scope
lScope
2 Normative references
2 Normative references
3 Terms and definitions
.3_ Terms and definitions
4 Management requirements
.4 Gen er al requirements
4.1 Organization and marragement respon- .1:..1 Impartiality
sibility
1:.1 Confidentiality
4.1.1 Organization
4.2.1 Management of information
4.1.1.1 General
4.1.1.3 Ethical conduct
12....2_ Release of information
.4:.2....3. Personnel responsibility
[includes confidentiality in (e)]
4.1.1.2 Legal entity
.5. Structural and governance requirements
4.1.1.4 Laboratory di rectiDr
.5..1 Legal Entity
4.1.2 Management resporrsibility
52 Laboratory director
4.1.2.1 Management commitment
.5..,ll Laboratory director compe tence
.52..2. Laboratory director resp onsi bili ties
.52....3_ Delegation of duties
.5.....3_ Laboratory activities
.5...1.1 General
5.....32 Con formance wit h requirements
.5A.1 General
.5....4.2_ Quality management
8.2....3_ Evidence of commitment
4.1.2.2 Needs ofusers
1...3. Requirements regard ing patients
5....3_..3_ Advisory activities
.5...5. Objectives and policies
.5...5. Objectives and policies
4.1.2.5 Responsibility, aut hority, and inter- .5..1 Str ucture and authority
4.1.2.3 Quality policy
4.1.2.4 Quality objectives and planning
relationships
54
4.1.2.6 Communication
5.A,l General b)
4.1.2 .7 Quality manager
5.4.2 Quality management
4.2 Quality management ::;ystem
.8. Management system requirements
S-.;p:~"""* ~
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IS/ISO 15189 : 2022
Table C.l (continueri)
ISO 15189:2012
4. 2.1 General requirements
ISO 1.5189 :2022 (this document)
8..1_ GenEral requirements and options
8..ll General
8..1_2 Fulfilment of management require-
ments
B__,_L_3_ Management system awareness
4.2.2 Doc umentation requirements
.8..2. Man agement system documentation
4.2.2.1Ge neral
8__,2__,_1_ Gerreral
4-.2.2 .2 Qu ality manual
[optiona.: no longer a requirement, see fL2__,_1.
NOTE]
4.3 Document control
B3. Control of management system documents
E...3..1 General
B__.__1,l Mcm agement of documents
4.4 Service agreements
fhl.. Serv :e agreements
4..4.1 Es tabli shment of servi ce agreements
4-.4.2 Review of servi ce agreements
4.5 Exa mination by re ferra l laboratories
.6..B2 Re ~~ rrallaboratories and consultants
4.5.1 Selecting and evaluating referral
lab orator ies and cons ultants
4.5. 2 Provi sion of examination results
4.6 Exrernal servi ces and supplies
.6..B Exte-nally provided products and
services
_6__,_B_,_3_ Re·liew and approval of externally
provided products and services
4-.7 Advisory services
.5...3..1 Ad,·isory activities
4.8 Resolu tion of complaints
21. Compiaints
7.7.1 Process
]__,]__,2_ Receipt of complaint
'4.9 Iden tification and control of
l:l:J Resolution of complaint
25. Nonconforming work
nonconformities
4.10 Corrective action
.8...1 Corrective action
.8.1.1 Actfu ns wh en nonconformity occurs
B...Z..Z Cor:::-ective action effectiveness
4.11 Preventive action
.8..1....3. Recxds of nonconformities
a.5. Actions to address risks and opportunities for i --:~ pro v ement
B.,_S_j_ Ideotification of risks and opportuni-
t ies for i::-1provement
.8...52 AcLng on risks and opportunities for
improve:::nent
4.12 Continual improvement
M lmprnveme nt
_8_,__Q_J_ Coritinual improvement
_8__._6__._2_ Laboratory patients, user and person-
nel feedb::tck
55
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\S/ISC 15189: 2022
Table C.1 (continued)
ISO 15189:2012
4.13 Control of records
ISO 15189:2022 (this document)
M Control of records
BA,l Creation of records
B.A:.l Amendment of records
4.14 Evaluation and audits
.8....1:.1 Retention of records
.8J3. Evaluations
4.14.1 General
.8....B....1 General
a..82 Quali ty indicators
.8..,lL3_ Internal audits
4.14.2 Periodic review of requests, and
suitability of procedures, and sam::'le
requirements
1,1_,_3_ Requests for providing laboratory
examinations
7.2 .3.1 General
7. 2.4.1 General
2..3. Examination processes
7.3.1 General e)
4.14.3 Assessment of user feedback
.8....6....2. Laboratory user and personnel feed -
4.14.4 Staff suggestions
4.14.5 Internal audit
4.14.6 Risk management
back
.8...ll.3. Internal audits
.5.& Risk management
.8...5. Actions to address risks and opportunities for imp rovement
li.5....11dentifications of risks and actions
taken
.a..5...2. Acting on r isks and opportunities for
improvement
4.14.7 Quality indicators
4.14.8 Reviews by external organizatio:J.s
4.15 Management review
4.15.1 General
4.15.2 Review input
4.15.3 Review activities
4.15.4 Review output
5·Technical requirements
56
5..,_5_ Objectives and policies d)
a..82 Quality indicators
.82 Nonconformities and corrective action
!1.9_ Management review
.8...2...1 General
B.,2.2 Review input
[not specified]
.8..2.1 Review output
.6. Resource requirements
~..; !r, 5::,"£ E~e unds
<he '<:ens= :'rom E.S for au-.,:.,. Ausuia Ca\ilal Asia Pvt Ltd - Naida (simron.saha@qacamail.com) -
, ~cess 203- 189.252. 1:>0 -
da:ed 2310812024 1!!:37:00 aga;ost BIS-2024082344
IS/ISO 15189 : 2022
Table C.l (continued]
ISO 15189:2022 (this document)
ISO 15189:2012
5.1 Personnel
.6..2. Person nel
5.1.1 General
.6.,_2_._1 Gener al
5.1.2 Personnel qualifications
6.2..2. Competence requirements
5.1.3 job descriptions
.6..2....3. Authorization
5.1.4 Personnel introduction to the organi-~ .62..1: Cont inuing education and professionzationaJ environment
a: development
5.1.5 Traini ng
.62...5. Pers onnel records
5.1.6 Competence assessment
5.1.7 Review of staff performance
5.1.8 Continuing education and professional development
5.1.9 Personnel records
5.2 Accommodation and environmental
conditions
.6...3. Facilities and env ironmental conditions
5.2.1 General
.6....3....1 Storage facilities
5.2.2 Laboratory and office facilities
6...3....1: Personnel facilities
5.2.3 Storage facilities
.6..3.....5. Sample collection facilities
5.2. 4 Sta ff facilities
.6....ll General
.6.3_2 Facillty controls
5.2.5 Patient sample collection facilities
5.2.6 Facility maintenance and environmental conditions
5.3 Laboratory equipment, reagents, and
consumables
M Equipment and .6Jl Reagents and consumables
5.3.1 Equipment
ME quipment
5.3.1.1 General
U.U Gener al
5.3 .1.2 Equipment acceptance testing
.6....4..2. Equipment requirements
5.3.1.3 Equipment instructions for use
.6A3. Equipment acceptance procedure
.6.A:A Equipment instructions for use
.6A...5. Equipment maintenance and repair
5.3.1.4 Equipment calibration and metrological traceability<
IM..Q
5.3.1.5 Equipment mainten~n~e and repair
Equipment adverse incident reporting
5.3 .1.6 Equipment adverse mc1dent report- .6.A:.1 Equ ipment records
ing
5.3.1.7 Equipment records
.6...5. Equipment calibration and metrological traceability
6_..li General
.6....52 Equipment calibration
6...5....3. Metrological traceability of measurement results
57
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IS/ISO 15189: 2022
Table C.l (continued)
ISO 15189:2012
ISO 15189:2022 (this document)
5.3.2 Reagents and consumables
hl Reagents and consumables
5.3.2.1 General
.6....6...1 Reagents and consumables - General
5.3.2.2 Reagents and consumables- recep- ~ .6....62 Reagents and con su mables - Receipt
and storage
tion and storage
5.3.2 .3 Reagents and consumables- acceptance testing
.6.....6..3. Reagents and consumables - Acceptance testing
5.3.2.4 Reagents and consumables- inven- .Q&A Reagents and consumables - Im·entotory management
ry management
5.3.2.5 Reagents and consumables- instructions for use
.6..,_6_,_5_ Reagents and consumables- Instruc-
5.3.2.6 Reagents and consumables- adverse incident reporting
.6...6..& Reagents and consumables - Adverse
5.3.2.7 Reagents and consumables- records
6.6.7 Reagents and consumables - Records
5.4 Pre-examination processes
72 Pre-exami nati on processes
5.4.1 General
7.2.1 General
5.4.2 Information for patients and users
7.2.2 Laboratory information for patients
and users
5.4.3 Request form information
5.4.4 Primary sample collection arr ::l handling
5.4.4.1 General
tions for use
incident reporting
2l....3. Requests for providing laboratory
examinations
LLll General
.L2.....3...l Oral requests
5.4.4.2 Instructions for pre-collection
activities
.
12.2....1: Primary sample collection and han .
f
II
.
.
.
.
s.4.4.3 Instructwns or co ectwn acbvJtJes dling
5.4.5 Sample transportation
5.4.6 Sample reception
5.4.7 Pre-examination handling, pr eparation, and storage
l...2....1J. General
.L.2A:,2 Information for pre-collection
activities
1.2....1...3. Patient consent
1.2....1:..1: Instructions for collection acti\'ities
22...5 Sample transportation
1...2..& Sample receipt
l,b.6J. Sample receipt procedure
~ Sample acceptance exceptions
7...2...1 Pre-examination handling, preparation and storage
l.2...l.1 Sample protection
221.,1.. Criteria for additional examination
requests
'l...2'LJ. Sample stability
12...3. Examination processes
5.5.1 Selection, verification, and vailidation 11...3.1 Genera"
5.5 Examination processes
of examination procedures
5.5.1.2 Verification of examinatior: proce- 11...3...2. Verification of examination methods
dures
58
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IS/ISO 15189 : 2022
Table C.l {continued)
ISO 15189:2012
ISO 15189:2022 (this document)
5.5.1.3 Validation of examination procedu res
.L..:L.3 Validc:tion of examination methods
:i.5.1.4 Measurement uncertainty of me asured quantity val ues
l3A Evaluation of measurement uncertainty
:i.5.2 Biological reference intervals or clini- 7.3.5 BioloEical reference intervals and
cal deci s io n values
cJinical deosion limits
:i.5.3 Documentation of exami nation procedures
13..6 Documentation of examination pro -
5.6 Ens uring qua lity of examination res uits
7_3.7 Ensuring the validity of exami nation
results
ce dures
5.6.1 Genera l
7,3.7.1 Gen eral
5.6.2 Quality control
7,3.7.2 Internal quality control (IQC)
5.6.2.1 General
5.6.2.2 Quality control materials
5.6.2.3 Quality control data
5.6.3 Interlaboratory comparisons
2...3.2.3. ExtErnal quality assessment (EQA)
5.6.3.1 Pa rticipation
5.6.3.2 Altern ative approaches
5.6. 3.3 Analysis of interlaboratory
comparison samples
5.6.3.4 Evaluation oflaboratory performance
5.6.4 Comparab ility of examinat ion results .2..3..1..1 Coin+Jarability of examination
results
5.7 Post-examination processes
7A Post-exam ination processes
5.7.1 Review of res ults
7A 1.2 Result review and release
MD Critical result reports
5.7.2 Storage, retention, and disposal of
clinical samples
7.4.2 Post-EXamination handling of samples
5.8 Repor ting of results
7.4.1 Reporting of results
5.8.1 Genera l
Mll General
5.8.2 Repo r t attributes
7.4.1.4 Spe ci al considerations for resul ts
5.8.3 Report content
l l t i Requirements for report s
7.4.1 .7 Add tt:ional information for reports
5.9 Relea se of results
7.4.1.2 Result review and release
5.9.1 General
Mll Gen eral
5.9.2 Automated sele ction and reporting of l..1:,_1_,_5 Autcmated selection, review, re results
lease and reporting of results
5.9.3 Re vi sed reports
M.1Jl Amendments to results reported
I
I
59
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-e:<F=
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IS/ISO 15189: 2022
Table C.l (continued)
ISO 15189:2012
ISO 15189:2022 (this document)
5.10 Laboratory information man c.5ement Lfi Control of data and information management
5.10.1 General
5.10.2 Authorities and responsibil::i es
5.10.3 Information system manage-nent
1...6...1 General
1...6.2 Authorities and responsibilities for
information management
2..63 Information systems management
l...6.A Dow ntime plans
1...6....5. Off site management
.La Continuity and emergency preparedness planning
60
Not specified
Annex A Additional requirements for Pointof-Care Testing
Annex A Table A.1 Correlation bet~-ree n
ISO 9001:2008 and this document
Annex 8 Table 8.1 Comparison betw een
ISO 9001:2015 and this document
Annex A Table A.2 Correlation bet"neen
and ISOj!EC 1702:i:2005 and this d:Jcument
Annex B Table 8 .2 Comparison between
ISO/ IEC 17025:2017 and this document
Annex 8 Table 8.1 Comparison of EO
15189:2007 to ISO 15189:2012
Annex C Table C.l Comparison between
ISO 15189:2012 and ISO 15189 :2022
&.:p:~a !r:
SSS Eoge unoer Y"li2 .cens::
"1lm E t$
~!if" Qua..!)' A\JS'f.ria Cen;a& Asia FVi. ltd - Naida (simran.saha@qacamail.com) -
, aoo:.css 203. tB:!l 252 t:>G - oa;ed ZW8120241iE 37:00 aganst BIS-20240823-44
IS/ISO 15189 : 2022
Bibliography
[1]
ISO 9000:2015, Quality management systems - Fu ndamentals and vocabulary
[2]
ISO 9001:2015, Quality management systems - Requirements
[3 ]
ISO 15190, Medica/laboratories - Requiremcn't sfor safety
[4}
IS O 15194, In vitro diagnostic medical de\~Jces - Measure ment of quantities in samples of
biological origin - Requirements for certifid reference materials and the content of supporting
docum entation
[5}
ISO 1.5198:2004, Clinical laboratory medicine - In v.'tro diagn ostic medical devices~ Validation of
user quality control procedures by the manufcrturer
[6J
ISO/ IEC 17011, Conformity assessment conformitv assessment bodies
Ji?-Equirements fo r accreditation bodies accrediting
ISO/ IEC 17021-1:2015, Conformity assessme"'"::r: - Requirements for bodies providing audit and
certification of management systems - Part l: Requirements
[B)
ISO 17034, General requirements for the compe'.:ence ofreference material producers
[9]
ISO/IEC 17043 :2 010, Conformity assessment - General requirements f or proficiency testing
[1c:
ISO 17511:2020, In vitro diagnostic medical ae·Jices - Requirements for establishing metrological
traceability of values assig ned to calibrators, trweness control materials and human samples
[11=
ISO 18113-1:2022, In vitro diagnostic medica[ liievices - Information supplied by the manufacturer
(labelling) - Part 1: Terms, definitions and g ~e ra/ requirements
[1 L]
ISO 19 011, Guidelines for auditing ma nagemet:lt systems
[E ]
ISO 20658 2), Requirements for the collectim and transport of samples for medical laboratory
examinations
[1'(
ISO TS 20914:2019, Medical laboratories uncertainty
[1!: ]
IS O 22367:2020, Medica/laboratories - Appfcr1tion of risk management to medica/laboratories
[1E]
ISO TS 22583:2019, Guidance for supervisors ~d operators ofpoint-ofcare testing equipment
[17 ]
IS O 228 70 3), Point-ofcare testing (POCT) - F't?!Juirementsfor quality and competence
[1f]
ISO/IEC 27001:2022, Information security, cy bersecurity and privacy protection securitv management systems - Requirements
[19:
IS O 35001, Biorisk management for laboratores and other related organisations
[2C ]
IS O 5725-1:1994, Accuracy (trueness and preds.ion) of measurement methods and results- Part 1:
General principles and definitions
[21]
IS O 20186-1:2019, Molecular in vitro diagnosFc. examinations- Specifications for pre-examination
processes for venous whole blood - Part 1: Isd Glted cellular RNA
PractLcal guide for the estimation of measurement
Information
2) First edition under preparation (previous edition was 3 Techniical Specification). Stage at the time of publication:
!SO 1T S 20658:2 022.
3')
To be withdrawn upon publication of this document.
61
Supplied by B3B Edge undet the i oense u-rn BIS for ~·ity Austria Cenucl As"' Pvlltd- Xana s;--oo.sana~o:ca.-naJI.com) IP address 203.189.;;52_130 - <E:ed 23/!lS/2024 18 37:00 "S"..ns! :r.s-2!l2~ll!!Z>-U
IS/ISO 15189 : 2022
[22]
ISO 20186-2:2019, /tfolecular in vitm diagnostic examinations - Specifications for pre-examincron
processes for venous 'Nhole blood- ?a1t 2: Isolated genomic DNA
[23]
ISO 20186-3:2019, Molecular in vitrc diagnostic examinations- Specifications for pre-examinction
processes for venous illhole blood- ?a1t 3: Isolated circulating cell f ree DNA from plasma
[24]
ISO 20166-1:2018, Molecular in vitrc: di,agnostic examinations- Specifications for pre-examinction
processes for formalin-fixed and parcf!fn-emhedded {FFPE) tissue - Part 1: Isolated RNA
[25]
ISO 20166-2:2018, Molecular in vit ro diagnostic examinations - Specifications for r;reexaminations processes for formalin -,fixed and paraffin-embedded {FFPE) tissue - Part 2: lsob::ed
proteins
[26]
ISO 20166-3:2018, Molecular in vitrc dwgnostic examinatio ns - Specifications for pre-examinction
processes for formaiin-fixed and parcfjfn-emhedded {FFPE) tissue - Part 3: Isolated DNA
[27]
ISO 20166-4:2021, Molecular in vitn:; diiagn ostic exam inations - Specifications for preexaminction
processes for forma iin-fixed and pcmffin-embedded {FFPE) tissue - Part 4: In situ detection
techniques
[28]
ISO 20184-1:2018, Molecular in vitrc dwgnostic examinations- Specifications for pre-examinction
processes for frozen tissue- Part 1: Isolated RNA
[29]
ISO 20184-2:2018, Molecular in vitrc d1:agnos tic examinations- Specifications for pre-examinction
processes for frozen tissue- Part 2: Isolated proteins
[30]
ISO 20184-3:2021, Molecular in vitrc diagnastic examinations- Specifications for pre-examinction
processes for frozen tissue- Part 3: Isolate d DNA
[31]
ISO 4307, Molecula r in vitro dia~nostic examinations processes for saliva- Isolated humc:l? DNA
[32]
ISO 23118, Molec ular in vitro dia;;nostic examinations - Specifications for pre-examincdon
processes in metabolomics in urine, ~.,en.ous blood serum and plasma
[33]
SI Brochure, The International Syste:n of Un its {Sf), BIPM (bttp:jjwww.bipm.org/en /puo.jca8r:s,
s_j-brocburej_)
[3 4]
CASCO QS-CAS-PROC/33, Common el"3ments in ISO/CASCO Standards 2020
[35]
CLSI Planning for Laboratory Operc:tions During a Disaster; Approved Guideline, CLS I docuornt
GP36-A. Wayne, PA: Clinical and Laborato ry Standards Institute; 2014
[36]
joint BIPM, 0/ML, !LAC and ISO decl::~ ration on metrological traceability, 2011 (http:ljwww.bipm
.or g/utils,fcommon/:;Jdf/ BIPM - OIML-ILAC- ~ SO joint declaration 2011.pd0
[37]
Joint Commission fo::- Guides in MetoLogy CJCGM) International vocabulary of metrology - Basic
and general concepts and associated terms (VIM) 3rd edition
[38)
INTERNATIONAL LAOORATORY ACCR ~m TATLD N COOP ERATION (ILAC). bttps:ljilac.orgf
[39]
Logical Observation Identifiers Naoes and Codes (LOINC and Nomenclature for Properties an d
Units (NPU, NGC) and SNOMED CT )lttps:l/loinc.org)
62
Specifications for pre-examincrfon
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The technical comm ittee responsible for th e preparation of this standard has revi ewed the provisions of
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coniunc:ion with this standard :
lntefTlational Standard/
OthEr Publication
ISO!lEC Guide 99 : 2007
Title
International vocabulary of metrology and associated terms (VI M}
Basic a1d general concepts
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