NABL
Which Laboratory you will
prefer to go?
ABC
Having untrained
staff
 Having old deviated
instruments
 Having Expired
chemicals
 Having poor
housekeeping

XYZ
Qualified and
Trained Staff
 Calibrated
instruments
 Valid Chemicals
 Proper storage
mechanism
 Good Housekeeping

What more do you expect from
Good Laboratory?
What is ISO?

ISO: International organization for
standardization, located in Geneva
– Purpose: To Establish Quality Standard
framework throughout the world
– First released its standard ISO 9001:1987
NABL
National Accreditation Board for Testing and Calibration
Laboratories (NABL) is the sole Laboratory Accreditation
body authorised by Government of India (GOI). NABL is an
autonomous body under the aegis of Department of Science &
Technology (GOI).
The accreditation to testing and calibration laboratories are
granted in accordance with ISO/ IEC 17025: 2005 and
medical testing as per ISO 15189: 2003.
NABL has established its accreditation system in accordance
with ISO/IEC 17011: 2004 which is followed internationally.
COMPETENCE OF A LABORATORY

In evaluating the competence of a laboratory, the
following methods are used:
– On-the-spot assessment of the laboratory by the
experts.
– By evaluating the results of a particular
test/measurement in a proficiency testing
programme.
International Standards and Guides
applicable to laboratories

ISO/IEC 17000 :

ISO/IEC 17025:
General Requirements for the
Competence of Testing &
Calibration Laboratories

ISO 15189
Medical Laboratories Particular Requirements for
Quality and Competence
:
Conformity assessment Vocabulary and general
principles
Functions of An Accreditation
Body

To promote the development and maintenance of
good practice in testing and measuring

To establish and maintain
recognition for its national
programmes
international
accreditation
NABL Accredits For:
Testing Laboratories
Biological
 Chemical
 Electrical
 Electronics
 Fluid-Flow
 Mechanical
 Non-Destructive
Testing etc.
 Clinical
 Forensic

Calibration Laboratories
Electro-Technical
 Mechanical
 Radiological
 Thermal & Optical
 Fluid-Flow etc

Accreditation




Procedure by which an authoritative body (NABL)
gives formal recognition that a body (laboratory) or
person (signatory) is competent to carry out specific
tasks (scope)
Criteria - ISO/IEC 17025 (includes all those
requirements of ISO 9001 relevant to the scope of
laboratories)
Assures the client that the procedures and test results
are technically valid
Recognizes the technical competence of laboratory
staff
Endorses the the laboratory operates the the
management system effectively
BENEFITS OF ACCREDITATION









National and international recognition
Public and industry acceptance
Assurance to clients of good laboratory practice
Provides global equivalence
Provides comparability in measurements
Decision makers can rely on test results
Improves staff motivation
Ensures better support in the event of legal
challenge
Saves money by getting it right at first time.
Information About Laboratory
Required by NABL
Testing /Calibration
 In-house/Open to others /Partially open
 Fixed/Mobile
 Legal status
 Name of the Lab

1. Lab is responsible for all legal
requirements.
2. Testing and Calibration activity for 1. Customer needs
2. Regulatory authorities.
3. Organizations providing recognition.
3. Scope of Management System

Labs Permanent facilities

At sites away from Permanent facilities

Associated temporary or mobile facilities

If the Lab is part of larger organization

-> Departments having conflicting interest do not
adversely influence the interest of lab.
4. Testing Requirements
-
-
Impartial
Personnel are free from any undue
commercial financial and other pressures
which might influence their technical
judgment
Confidential
Integrity
5. Managerial & Technical
Personnel
* have authorities and resources needed to
carry out their duties.
* to identify the occurrences of departures from
the management system or from the procedures
for performing testes/ and / or calibration
* to initiate actions to prevent or minimize such
departures.
b) Free from any internal or external pressures
a)
c) Policies and Procedures for protection of
-
Its customer’s confidential information
-
Proprietary rights
-
Electronic Email.
Policies and Procedures for
Protection of customers confidential
reports
 Property rights
 Protecting the electronic storage and
transmission results
 Having confidence in its competence,
impartiality, judgment or operational
integrity.

Organization Chart A
Organization Chart B
Organization Structure
Who is Q.M. /T.M./Dy QM/Dy TM ?
 Can all be one person?
 What is NABL requirement for QM?
 What should be responsibilities of QM and
TM?

Quality Manager (QM)
Responsibilities
 Day to day administration lab.
 To maintain discipline, safety within the lab.
 initiating needs for training of lab personnel.
 Checking for effectiveness for testing & management systems.
 Attending customer complaints and customer feedback and conducting
customer satisfaction survey.
 To conduct management review meetings& internal audits
 Establishing, implementing & maintaining the laboratory management
system as per IS/ISO 17025: 2005.
 Liasioning with NABL for Laboratory accreditation and managing
associated activities
 Preparation of Test Report
 Reports to Director on QMS as well as Branch manager.
Fulfills the Requirements of Clause No.4
Technical Manager (TM)
Responsibility
 Preparation &/ Approval of Test SOPs.
 Maintenance & calibration of Lab. Equipments.
 Allotment of samples to chemist
 Preparation of Test Report
 Liasioning with external agencies
 Signing test report for final approval.
Fulfills the Requirements of Clause No.5
Appointment
letter of QM
& TM
Organization and Management
Structure
Its place in parent organization.
 Relationship between Quality
Management, Technical Operations and
Support Services.
 Responsibility, authority and
interrelationship of all personnel
managing, performing, verifying the work
affecting in quality of tests/ calibration.

Provide adequate supervision of
testing and calibration staff
including traineesBy persons familiar with methods and
procedures.
 Purpose of each test and/ or calibration
 Assessment of the test or calibration results.

 Technical management has the
overall responsibility for the
technical operations and
provision of resources.
Appoint Quality Manager –
responsible for Ensuring that the management system
related to Quality Management is followed
all times.
 Have access to the highest level of
management at which decision are made
on Laboratory Policy or resources.

Appoint deputies for key
managerial personnel
 Ensure that personnel are
aware of their activities and
contribution to Management
System.
4.2 Management System
4.2.1 Laboratory shall
 Establish
 Implement
 Maintain
Management system as per scope of the
activities.
4.2.1 Lab shall document its
 Policies
 Procedures
 Systems
 Programmes
 Instructions
Necessary to assure the quality of the test /
calibration.
4.2.1 The Systems documentation shall be
 Communicated
 Understood
 Be available
 Implemented
By concerned persons.
4.2.2 Quality Policy shall be defined to include
 Management’s commitment to good professional
practice and to the quality of its testing and
calibration in servicing its customers
 Managements statement of the Laboratory’s
standard of service.
 The purpose of management system related to
quality.
 All personnel concerned with testing and calibration
activities with the lab familiar with the quality
documentation and implement the policies and
procedures in their work.
Comply with this International standard and
to continually improve the effectiveness of
Management system.
 Tests and calibration shall always be carried
out as per the stated methods and customers
requirements.

Quality Policy A

We are committed for providing quality
testing as per ISO 17025 and following
best laboratory practices.
Quality Policy B
XYZ is committed to carry out reliable, accurate and timely testing related to
Clinical Biochemistry, Clinical Pathology & Serology of samples by:* Following Good Clinical Laboratory practices, complying with IS/ISO
17025:2005 & NABL 104.
* Following requirement of national and international standards for testing.
* Providing best quality of services to satisfy customer’s requirements.
* Creating awareness amongst the staff about established policies and
procedures
* Providing training to employees to update and enhance their skills,
knowledge & competence.
* Ensuring effective implementation of Laboratory Management System in
day to day activities.
* Ensuring proper maintenance and Calibration of equipment. Monitoring,
measuring and continually improving the conditions affecting the test.
The Policy is communicated to all the employees and is reviewed once in
year for its suitability and its effectiveness.
Date:
Managing Director
4.2.3 Management Commitment

For development and implementation of
Management System.

Continually improving its effectiveness.
4.2.4 Communicate to the organization the
importance of meeting customer
requirements.
 Importance of meeting statutory and
regulatory requirements.
 Maintain integrity of Management system
when changes are planned and
implemented.
Quality Objectives
Quantified monitoring and measurement
statements for achieving policy
 SMART

Examples – Which are
SMART Objectives









Reduce error in sample collection & identification.
Reduce error in transportation and processing.
Generate error free examination report.
Optimize the turnaround time of all examinations.
Attend complaints promptly to enhance customer satisfaction.
Reduce equipment downtime.
Ensure control of Z Score in testing and measurement.
Ensure acceptable performance in External Quality Assessment
Scheme.
Enhance skill, competency and knowledge of employees through
training.
4.2.5 Quality Manual
Include or make reference to the
supporting procedures including technical
procedure.
 Include structure of the documentation
used in the management system.
 Roles and responsibilities of technical
management and quality manager.
 Responsibilities for ensuring compliance
with International Standard.

Document












What is document?
(Exercise mix documents /records-which are documents)
Show cover page of Quality Manual, What do you notice?
How to identify document?
Preparing /reviewing/ approving/issuing
Document changes, how will you carry out?
Controlled/ uncontrolled
External origin document
Document structure.
What is obsolete document?
How will you ensure it is removed from point of use?
How will you distribute documents?
What is document?
Documents may be in any form or type
of medium which reflects in terms of
information or guideline,
 following examples:
paper (“hard copy”)
magnetic
electronic or optical computer
disc
photograph
master sample

Examples of Documents
Generic Examples of Documents ( Soft/Hard)
•
•
•
•
•
•
•
•
•
•
•
•
Policies
System procedures
Operational procedures
Work instructions
Blank forms
Manuals
Plans and programs
Drawings and schematics
Standards and specifications
Videos
Photographs, Snapshots
Sample boards
Good Document Control
Identification & Traceability
 Authorities for Preparation, Review
,Approve & Issue of document
 Document Issue, Distribution & Control
(To ensure Current document is
available at point of Use)
 Document Change & Obsolete Control
 Control of External Origin Documents
 Master List

Identification & Traceability of Document
Name of the company & Logo
 Title of document
 Identification Number
 Issue/ Revision Number
 Issue/ Revision Date
XYZ Ltd., Nagpur
Title:
APEX MANNUAL
 Page Control

Doc.No:
XYZ/EnMGR/AML
Issue/Rev No:
01/00
Iss/Rev.Date:
01.05.15
Page No:
1 of 2
Authorities for Preparation,
Review ,Approve & Issue of
document
Authority
Sr.no
Doc.Name
Doc.No.
Prepared &
Reviewed &
Issued By
Approved By
XYZ/POLICY
MR
MD
XYZ/OBJECTIVE
MR
MD
MR
MD
1
Policy
2
Objectives
3
Apex Manual
XYZ/AML
Procedure/Work
XYZ/SOP/
4
Instructions
Abbreviation of SOP
Jr.
Engineer/Activity
Incharge
Section/Departm
ent Head
Document Issue, Distribution & Control
Master Copy: Original Copy generally kept with
originator (Soft/Hard)
Controlled Copy: Distributed at point of
uses/locations with controlled number to the concern(
Here to give current version, responsibility lies with
Originator)
In soft: Write protected and controlled sharing through
server
Uncontrolled/Reference Copy: For reference
Reading ( Here there is no responsibility of originator
Document Change & Obsolete Control Process
Change: any modification to product, document, process, equipment, instrument,
system, facility etc.
Change control: procedure reviews, verifies, regulates, manages, approves and
controls changes made to the existing operating system or facility or process or
procedure or document or product of any combination
The key principles of change control are understanding and documenting:
What was done, why, when, where, by whom, how and Results, including the
impact of changes to other processes.
Sr. No.
Steps to Change the Document
1
Changes are proposed (In the Format: Encl)
2
Change Reviewed by Preparing authority
3
Change approved by Approving Authority
4
Changes made in the document
5
Master list of document modified
6
Entry made in Document change record
7
New document issued to concerned person as per distribution list
8
Old document retrieved from the place of use , Marked as obsolete & filed
separately
Format of Document Change Request
Sr.
No
1.
Date: 15.05.2015
Document Document
Original
01
Name
ID No
Issue/Rev. no
DCN No:
Changes required
More Columns
XYZ/DC
01/00
Required in data
collection Table
Change Impact details( by Preparing authority/TL)
Data
Collection
Reason for change
Document
adequacy
Reviewed by (Preparing Authority):________________________(Sign,, Name, Date, Time)
Approved By(Approving Authority):________________________(Sign,, Name, Date, Time)
Format of Change Record
Sr.
No
.
1
Docume
nt
change
note no
01
Docume
nt name
Data
Collection
Document
Identificati
on No.
XYZ/DC
Origina New Date
l
Issue
of
Issue / /Rev Iss/R
Rev no. no.
ev.
01/00
Change
made
Issued
to
Columns
01.05.
added in data As per
01/0 2015/
collection
distribut
1
15.05.
Table
ion list
2015
Control of External Origin Documents
SR.NO
1
2
Name of the standard
ISO 17025:2005 Standard
Operational System CDs
Revision/year
Publications
Controlled By
2005
BIS
MR
ABC
Support &
Implementation
Head
2015
Master List Of Document
S.N
NAME OF DOCUMENTS
ISSU ISSUE/R PREPARE APPROVE ISSUE TO
E/RE
EV.
D
D
DOCUMENT V.
NO.
NO.
DATE
BY
BY
YZPECS Level
1
1
2
Apex Manual
Annual Internal Audit
Calender
Internal Audit Schedule
3
Internal Audit observation
Sheet
4
Internal Audit Summary
Report
XYZ/MR/AM
01/05/
01/00
L
15
MR Documents
XYZ
/MR/AIAC 01/00
XYZ
/MR/IAS 01/00
XYZ
/MR/IAO 01/00
XYZ
/MR/IASR 01/00
MR
01.05.1
5
MR
01.05.1
5
MR
01.05.1
5
MR
01.02.1
5
MR
General
XYZ
Manager Members
General
XYZ
Manager Members
General
XYZ
Manager Members
General
XYZ
Manager Members
General
XYZ
Manager Members
Protection, Retrieval
4.3. DOCUMENT CONTROL


Establish procedure for control of all documents
(Internally generated or from external sources).
Documents include:–
–
–
–
–
–
–
Regulations
Standards or other normative documents.
Test and Calibration methods
Drawings
Software
Specifications
Instructions.












Manuals
Policy statements.
Photograph
Procedures
Specifications
Calibrations tables
Charts
Text Books
Posters
Notices
Memorandum
Hard or Soft Copy
4.3.2 Document Approval and
Issue
4.3.2.1 Authorized person for preparation,
review, Approval and issue of documents.
 Master list to identify current revision
status.
 List for distribution of documents.
 Avoid use of invalid/ obsolete documents.
4.3.2.2 Procedure shall ensure: Availability of authorized editions of
documents at user location
 Periodic review and revision of
documents.
 Removal of invalid/ obsolete documents
from all points of issue / use to avoid
unintended use.
 Marking of obsolete documents, suitably,
retained for legal or knowledge purpose.

Identify documents uniquely.

Identification shall include:–
–
–
–
Date of Issue and/ or revision.
Page numbering & total no. of pages.
Mark to signify the end of document.
Name/ signature of issuing authority.
4.3.3 Document Changes.





4.3.3.1 The same function should review and
approve the changes.
Provide access to them to pertinent background
information.
Identify the changes in the documents (Itallyic).
The procedure can include amendment of
documents by hand if authorities are defined.
In such case amendments should be clearly
marked, initiated and dated.
Describe in the procedure how changes in
document are maintained and controlled in
computerized system.
Before you accept to carry out testing
work, what will you ascertain?
 How will you amend the requirements?
 What requirements to be fulfilled while
sub contracting the work?

4.4 Review of Requests,
Tenders & Contracts
WHO IS CUSTOMER OF THE LAB
 HOW MANY CUSTOMERS
 INTERNAL OR EXTERNAL
CUSTOMERS
 HOW MANY SAMPLES
 WHAT TYPE OF AGREEMENT WITH
CUSTOMER
 CHANGES IN CUSTOMER
REQUIREMENTS

4.4 Review of Requests, Tenders
& Contracts.


a)
b)
c)
4.4.1 Establish the procedures for the review of
requests, tenders and contracts.
Ensure that:The requirements including the methods to be
used, are adequately defined, documented and
understood.
The laboratory has the capability and resources
to meet the requirements.
The appropriate test and/ or calibration method
is selected and is capable of meeting the
customers requirements.
Resolve any differences between requests
or tender and the contract before work
begins.
 Contract is applicable and acceptable to
laboratory and the customers.

Review Parameters for contract review:- Financial, Legal and Time schedule.
 Capability to execute work
 Physical capabilities.
 Personnel and information resources.
 Skill and expertise of personnel
 Earlier participation in inter laboratory
comparisons or proficiency testing
 Running of trial test or calibration program using
samples in order to determine uncertainties of
measurement, limit of detection, confidence
limits.
 Contracts may be written or oral.
4.4.2 Records of reviews be maintained
including.: Discussion with customers.
 Review the work that is subcontracted.
4.4.4 Communicate to the customer any
deviations from the contract.
4.4.5 For any amendments, review as per the
contract review process be repeated.
Communicate amendments to all
concerned.
SUBCONTRACTING WORK
IF A LAB DOES NOT PERFORM ANY
TESTING/CALIBRATION WORK AND
SUB-CONTRACTS ALL THE WORK
THEN WILL YOU GIVE
ACCREDITATION TO IT???
 TO WHICH LAB WORK CAN BE SUBCONTRACTED?
 WHICH TYPE OF WORKS CAN BE
SUB-CONTRACTED?

4.5 Subcontracting of Tests &
Calibrations

4.5.1 Work can be sub- contracted because of –
–
–
–
–
–

Workload
Need of Expertise
Temporary incapacity
Permanent subcontracting
Franchisee arrangements
Give the work to a competent subcontractor who
complies with ISO 17025.
4.5.2 Communicate the arrangement of sub
contracting to customer in writing and get
the approval preferably in writing.
4.5.3 Laboratory owns the responsibility for
subcontracted works if it has initiated the
process.
4.5.4
- Maintain register of subcontractors
– Record of evidence that subcontractor’s
compliance with ISO 17025.
Purchase
What needs to be observed, while
purchasing the lab materials?
 What should be done after receiving
material from supplier?
 How to evaluate Suppliers?
 What records are related to purchase?

4.6 Purchasing services and
supplies.
4.6.1 Establish Policy & procedures for
SELECTION and PURCHASE of services and
supplies that affect quality of test.
 Procedure for purchase, Receipt, storage of
reagents, laboratory consumables.
4.6.2
 Material should be used only after inspection and
ensuring that they meet the requirements.
 Services & Supplies should comply with
specified requirement.
 Records of inspection be maintained.
4.6.3 Describe clearly the requirements of supplies
and services in purchase documents.
 Review and approve the documents for technical
content before release.
 Technical content may include:
–
–
–
–
–
–
–
–
–
–
Type
Class
Grade
Precise Identification
Specifications
Drawings.
Inspection instructions
Approval of Test results
Quality required
Management system standard.

4.6.4 Evaluate the suppliers and maintain
record of evaluation.
Customer
Who is your customer?
 How will you access customer
requirements?
 What are the customer requirements?
 How customer complaint be handled?

4.7 Service to the Customer


4.7.1 Cooperate with customer, understand
requirements and request.
Cooperation for:– Visiting the relevant areas of Lab
– Preparation, Packaging and dispatch of test items
needed by customer for verification purpose.



Provide good communication, advice and
guidance on technical matters.
Maintain communication throughout the work.
Communicate with customer if any major
deviations or delays.
4.7.2 Obtain feedback from customers.
 Analyze and improve the system.
4.8 Complaints.
Policy and procedure for resolution of
complaints.
 Record of complaints, investigations and
corrective actions.

Complaint
Redressal
Process
Non Conforming Work
What is Non conforming work?
 How can non conforming work be noted?
 What should be done if non conforming
work is observed?

4.9 Control of non – conforming
Testing/ Calibration.


4.9.1 Establish policies and procedures to identify non –
conforming work [Work that does not conform to its
own procedures or the agreed requirements of the
customers]
Procedure shall ensure:a)
The responsibilities and authorities for the management of
nonconforming work are designated and actions (including
halting of work and withholding of test reports and calibration
certificates, as necessary) are defined and taken when
nonconforming work is identified.
b) An evaluation of the significance of the nonconforming work is
made.
c) Correction is taken immediately, together
with any decision about the acceptability of
the nonconforming work.
d) Where necessary, the customer is notified and
work is recalled.
e) The responsibility for authorizing the
resumption of work is defined.

Take Corrective actions.
4.10 Improvement
Improve the effectiveness of management system
through the use of: Quality Policy
 Quality Objectives
 Audit results
 Analysis of Data
 Corrective Actions
 Preventive Actions
 Management Review
CAPA
What is difference between correction,
corrective action and preventive action?
 How to carry out corrective action?
 Root cause Analysis.
 Cause effective diagram.
 Paired comparison.

4.11 Corrective Actions


4.11.1 General
Corrective actions are required when
– Non- conforming work occurs
– Departure from the policies and procedures in the
management system or technical operations occur.

Problem with Management System can be identified
through activities such as:–
–
–
–
–

Contract of Non- conforming work
Internal or External Audits
Management Reviews
Feedback from customers.
Feedback from staff.
Establish Policy and Procedure for Corrective Action.
4.11.2 CAUSE ANALYSIS
 Investigate to determine Root cause
Potential causes can include: Customer requirements
 Samples
 Sample Specifications
 Methods and Procedures
 Staff Skills and training
 Consumables
 Equipment and its Calibrations.
Cause and Effect “Skeleton”
Materials
Procedures
Quality
Problem
People
Equipment
Fishbone Diagram
Measurement
Faulty testing equipment
Incorrect specifications
Improper methods
Inaccurate
temperature
control
Dust and
Dirt
Environment
Human
Machines
Out of adjustment
Poor supervision
Lack of concentration
Tooling problems
Old / worn
Inadequate training
Defective from vendor
Not to specifications
Materialhandling problems
Materials
Poor process
design
Ineffective quality
management
Deficiencies
in Testing
design
Process
Quality
Problem
4.11.3 Selection and Implementation of C.A.
 Identify Potential Corrective Actions.
 Select and Implement the action(s).
 Document required changes resulting from
Corrective Actions.
4.11.4 Monitor the effectiveness of
Corrective Actions.
4.11.5 Additional Audits.
Audit the activities or areas if it is observed that
compliance with Policies and procedures or
compliance with International Standard is
doubtful.
 Additional audit helps to confirm the
effectiveness of corrective actions.
 Additional audit is necessary when a serious
issue of risk to the business is identified.

4.12 Preventive Actions.
4.12.1 Identify needed improvements and
potential sources of non – conformities.
 Plan the preventive action.
 Implement and monitor
4.12.2 Procedure for Preventive Actions
should include the initiation of such actions
and application of controls to ensure that
they are effective.
 Preventive action is a pro – active process to
identify opportunities to improvement rather
than a reaction to the identification of
problem or complaints.
 Preventive actions may involve:
–
–
–
–
Analysis of data
Trend Analysis
Risk Analysis
Proficiency testing results.
Records
What are records?
 How to identify records?
 How to maintain records
 How to destroy records?
 How to correct mistake in records?

What is Record?
A document which has been authenticated
and cant be changed.
 An evidence about the past, especially an
account/information kept in writing or
some other permanent form
- All documents are not records.
- All records are documents

CONTROL OF RECORDS
IDENTIFICATION
 STORAGE & RETRIEVAL
 RETENTION TIME
 DISPOSAL
 MASTER LIST

Record Indexing & Storage
Master List Of Record
S.N
1
2
3
4
5
6
ISSU ISSU
RETE
RECOR
PREPAR APPRO
E/RE E/RE
ISSUE LOC NTIO
D
ED
VED
V.
V.
NAME OF RECORDS
ATIO N
N PERIO
NO.
NO. DATE BY
BY
TO
D
MR Records
Annual Internal Audit PTPS/MR
01.05.
Calender
/AIAC 01/00 15
PTPS/MR
01.05.
Internal Audit Schedule
/IAS 01/00 15
Internal Audit
PTPS/MR
01.05.
observation Sheet
/IAO 01/00 15
Internal Audit Summary PTPS/MR
01.05.
Report
/IASR 01/00 15
PTPS/MR
01.05.
Non conformity Report
/NCR 01/00 15
PTPS/MR
01.05.
Document Change Note
/DCN 01/00 15
MR
General PTPS MR
Manager Members Cabin 3 Yrs.
MR
General PTPS MR
Manager Members Cabin 3 Yrs.
MR
General PTPS MR
Manager Members Cabin 3 Yrs.
MR
General PTPS MR
Manager Members Cabin 3 Yrs.
MR
General PTPS MR
Manager Members Cabin 3 Yrs.
MR
General PTPS MR
Manager Members Cabin 3 Yrs.
4.13 Control of Records
4.13.1 General
4.13.1.1 Establish and maintain procedure for : Identification
 Collection
 Indexing
 Access
 Filing
 Storage
 Maintenance
 Disposal of Quality & Technical records.

Quality records include:– Reports form Internal Audits.
– Reports of Management Review.
– Records of Corrective & Preventive Actions.

Records should be
– Legible
– Retrievable
– Protected from damage, loss

Retention time
Records may be in Hard Copy or
Electronic Media.
 Security and confidentiality of Records
 Electrically stored records:
–
–
–
–
Protection
Back up of records
Prevent unauthorized access
Prevent amendment of records
4.13.2 Technical Records
4.13.2.1 Retain the records for defined Period Records of Original observations.
 Derived data.
 Information to establish an audit trait.
 Calibration records
 Staff records
 Copy of each test report
 Copy of Calibration Certificate issued.

Record of each Test/ Calibration should include
sufficient information to– Identify factors affecting uncertainty
– Repetition of test under conditions as close as
original

Include–
–
–
–
Identity of person responsible for
Sampling
Performance of each test
Checking of results.


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







Technical records are accumulation of data and
information which result from carrying out tests/
calibrations and which indicate whether specified
quality or process parameters are achieved.
These may include:Forms
Contracts
Work checks
Work Books
Check Sheets
Work Notes
Contract Graphs
External and Internal test Reports
Calibration Certificates
Customers Notes papers and Feedback.

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4.13.2.2 Observations, data and calculations
should be recorded at the time they are made and
shall be identifiable to the specific task.
4.13.2.3 If mistake occurs in recordsCross out each mistake. Do no Erase.
Make it illegible or delete it.
Enter corrected value alongside.
Person making alterations/ correction should sign
and initial.
In case of electronic record similar actions be
taken to avoid loss or change of original data.
Internal Audit
What is internal audit?
 Why to carry out internal audit?

Internal Audit
Process Review for evaluation of system
against set system
 Frequency: Quarter/Six Monthly
 Output: Improvement of System
 Audit Documents:

–
–
–
–
–
Internal Audit Annual Calendar
IA Schedule
IA Observation Sheet
IA Summery Sheet
NCR
4.14 Internal Audit
4.14.1 Conduct internal audit to verify that: The operations comply with the requirements of
management system & ISO 17025.
 Prepare procedure and schedule of internal audit.
 Internal audit program should cover all elements
of management system.
 Quality manager should plan and organize audits.
 Audit should be conducted by independent,
trained and qualified personnel.
4.14.2 If during the audit effectiveness of the
operation or the correctness of results is
doubtful, take timely corrective actions,
 Inform customers if it is found that Lab
results might have been affected.
4.14.3 Record the area of activity audited,
audit findings & Corrective Actions.
 Verify the effectiveness of implementation
through following audit.
Management Review
What is management review?
 What should management review about
lab?

Management Review

By Top Management
– covers
Process Performance
 Customer Feedback
 Non conformity & Corrective actions
 Statutory & Regulatory Compliance
 Resource Provision
 Audit Results
 Opportunity for improvement

4.15 Management Review
4.15.1 Conduct regular management review
meetings to ensure continuing suitability and
effectiveness
Agenda
 The suitability of policies and procedures.
 Reports from managerial and supervisory
personnel.
 The outcome of recent internal audit.
 Corrective and preventive actions.
 Assessments by external bodies.
 The results of inter-laboratory comparisons or
proficiency test.
Changes in the volume and type of the work.
 Customer feedback
 Complaints.
 Recommendations for improvement
 Other relevant factors, such as quality control
activities, resources and staff training.

4.15.2 Record minutes of management
reviews
 Take actions on recommendations of
Management Reviews.

5. TECHNICAL REQUIREMENTS
5.1.1 Factors affecting the correctness and
reliability of tests / Calibration
 Human Factors
 Accommodation and Environmental conditions
 Tests and Calibration Methods and method of
validation.
 Equipment
 Measurement Traceability
 Sampling
 Handling of Tests & Calibration items.
5.1.2 The extent to which these factors
contribute to the total uncertainty of
measurement differs considerably between
types of Tests & between types of
calibrations.
* These factors to be considered for  Developing test and calibration methods and
procedures.
 Training and qualification of personnel
 Selection and calibration of equipments and
uses.
5.2 PERSONNEL
Ensure competence of all who
 Operate specific equipment
 Perform tests and / or calibrations
 Evaluate results
 Sign test reports and Calibration
certificates
Provide supervision of staff undergoing training

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Qualified staff
Education
Training
Experience
Demonstrated Skills.
Personnel certification as required by
Regulatory bodies.
Customers.
Standards in specific areas.
Requirements for personnel responsible for
opinions and interpretations included in
reports: Qualification
 Training
 Experience
 Satisfactory knowledge of Testing work.
 Relevant knowledge of the technology used
for manufacturing of the items, materials,
products tested.
Knowledge of way the products are to be
used or intended to be used.
 Defects or degradation which may occur
during or in service.
 Knowledge of the general requirements of
legislation and standards.
 Understanding of the importance of
deviations found with regard to normal use of
products, items or materials.

Training
 Formulate the goals w.r.t. education, training
and skills of Lab personnel.
 Define Policies and Procedures for
identifying training needs and providing
training.
 Relevance of training program for the present
and future anticipated tasks.
 Effectiveness of training.
Contract Personnel
 Can be employed.
 Provide supervision.
 Are competent.
 Work according to Lab’s Management
System.
5.2.4  Maintain job descriptions for
managerial, technical and key support
personnel.
 Job Descriptions should include
responsibilities for
 Performing tests/ calibrations
 Planning of tests/ calibrations & evaluation of
results.
 Reporting opinions and interpretations.
 Method modification and development
Validation of new methods.
 Expertise and experience required.
 Qualifications and training programmes.
 Managerial duties.

5.2.5 AUTHORISATION.
To perform particular types of sampling,
tests, calibration.
 To issue test reports and calibration
certificates.
 To give opinions and interpretations.
 To operate particular type of equipment

5.2.5 Record of
 Relevant Authorization with date
 Competence
 Educational and professional qualifications.
 Training
 Skills
 Experience of all Technical and Contractual
personnel.
 Ready availability with date.
5.3. ACCOMODATION AND
ENVIRONMENTAL CONDITIONS
5.3.1 For correct performance of the tests/
calibrations.
 Environmental conditions should not
invalidate the results or adversely affect
required quality of measurement.
 Care at site, while taking sample
 Technical requirements for accomodation
and environmental conditions affecting
tests needs to be documented.
5.3.2 Conditions affecting Test results.
 Dust
 Electromagnetic disturbances.
 Radiation
 Humidity
 Electrical Supply
 Temperature
 Sound
 Biological Sterility
 Vibrations.
Monitor, control and Record Environmental conditions as
required by relevant specifications, methods or procedures.
Stop the tests/ calibration if the environmental conditions are
jeopardizing the results of tests.
5.3.3.
Separation between neighboring
areas to prevent CrossContaminations/Interference.
5.3.4.
Limited access to test area as
required. Control the access.
5.3.5 Good Housekeeping
Procedure if required for housekeeping.
5.4 TESTS AND CALIBRATION
METHODS AND METHOD
VALIDATION
5.4.1 Methods and Procedures for –
 Sampling
 Handling
 Transport
 Storage
 Preparation of items to be tested/ calibrated.
 Estimation of measurement uncertainty
 Statistical techniques for analysis.
 Instructions for Use and Operation of the relevant equipment
 Handling and preparation of items of Testing
Keep updated and make available all relevant
instructions, standards, manuals and reference data.
Deviation from tests and calibration methods is
acceptable if deviation is Documented
 Technically justified.
 Authorized
 Accepted by Customer.
International Standards, National Standards or other
regional specifications may not be rewritten as
procedures,
5.4.2 SELECTION OF METHODS
Test and/or Calibration methods should Meet the requirements of the customer
 Appropriate for the purpose
Methods published in International, National,
Regional standards preferably be use.
Use latest version of the standard.
Use of methods given in scientific texts/ journals,
specified by manufacturer of equipment.
 Non – standard methods to be confirmed
with the customer.
 If standard method changes, confirmation
with the customer shall be repeated.
 Confirm with the customer if the method
suggested by customer is outdated or
inappropriate.
5.4.3 Laboratory Developed
Methods
Develop tests and calibration methods in a
planned way.
 Assign qualified personnel with resources.
 Ensure effective communication.

5.4.4 Non- standard Methods
Take customer approval
 Give clear specification of customer
requirement
 State purpose of Test
 Validate before use.

5.4.4 For new test/ calibration method, procedure
should be developed to contain the following:a)
Appropriate identification.
b) Scope.
c)
Description of the type of item to be tested or
calibrated.
d) Parameters or quantities and ranges to be
determined.
e)
Apparatus and equipment, including technical
performance requirements.
f)
Reference standards and reference materials
required.
g) Environmental conditions required and any
stabilization period needed.
h) Description of the procedure, including
- affixing of identification marks, handling,
transporting, storing and preparation of items.
- checks to be made before the work is started.
- checks that the equipment is working properly
and, where required, calibration and adjustment of
the equipment before each use.
- the method of recording the observations and
results.
- any safety measures to be observed.
i)
Criteria and/ or requirements for approval /
rejection
j) Data to be recorded and method of analysis and
presentation.
k) The uncertainty or the procedure for estimating
uncertainty.
5.4.5 Validation of methods
 Validation is the confirmation by examination and the
provision of objective evidence that the particular
requirement for a specific intended use are fulfilled . To
ensure methods are fit for intended use.
 Methods to be validated.
 Non- standard methods
 Laboratory designed/ developed methods
 Standard methods used outside their intended scope.
 Amplifications and modifications of the standard
methods.
 Validation may include procedures for sampling,
handling and transportation.
 Techniques used for determining the
performance of method: Calibration using reference standard or reference
material.
 Comparison of results achieved with other methods.
 Inter Laboratory comparison.
 Systematic assessment of the factors influencing the
result.
 Assessment of the uncertainty of the results.
 5.4.5.2 If some changes are made in the validated
standard methods the influence of such changes
should be documented and new validation should be
carried out.
 5.4.5.3 The range and accuracy of the values
obtained from the validated methods include Uncertainty of the results.
 Detection limit.
 Selectivity of the method
 Linearity
 Limit of repeatability & reproducibility
 Robustness against external influences.
 Cross sensitivity against interference from the
matrix of the sample/ test object.
 Validation includes: Specification of the requirements
 Determination of the characteristics of the
methods
 Check that requirements can be fulfilled by
using the method
 Statement on the validity.
 Regular reviews should be carried out during
the development of the method.
 To any changes in the development plan, the
same should be approved and authorized.
 Validation is a balance between costs, risks
and technical possibilities.
5.4.6 Estimation of uncertainty of
measurement
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

5.4.6.1
Estimate the uncertainty of measurement for all
calibrations and types of calibrations.
Reasonable estimation of uncertainty based on
knowledge of the performance of the method, and on the
measurement of scope is needed.
Rigorousness of uncertainty measurement depends on- The requirements of test method
- Requirements of the customer.
- Existence of narrow limits on which decisions on
conformity to specifications are based.
 Sources of uncertainty
 Reference standards.
 Reference material used.
 Methods and equipment used.
 Environmental conditions.
 Properties and conditions of the item being tested.
 Operator.
 When estimating the uncertainty of measurement,
all uncertainty components which are of importance
in the given situation will be taken into account
using appropriate method of analysis.
5.4.7 CONTROL OF DATA
5.4.7.1 Ensure proper checks on calculations and
Data transfers.
5.4.7.2 When automated equipment or computers
are used for
 Acquisitions
 Processing
 Recording
 Reporting
 Storage
 Retrieval of test/ calibration data
Ensure –
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Computer software is documented and validated.
Procedures for protecting data are established and
maintained covering
Integrity & confidentiality of data entry
Data storage
Data transmission
Data processing.
Proper environmental and operating conditions
are provided to computers/ equipments.
5.5 EQUIPMENT
5.5.1 Lab should have –
 All items of sampling
 Measurement and test equipment for all the work
carried out
5.5.2 Equipment/ softwares should be capable of
carrying the work.
 Establish the calibration programmes for key
quantities or values of instruments.
 Before use calibrate and check instruments.
5.5.3 Provide authorization for operating equipment

Provide upto date instructions for use.
5.5.4 Uniquely identify each item of equipment or
software.
5.5.5 Maintain records of each item of equipment
covering the following:a)
The identity of the item of equipment and its
software.
b) The manufacturer’s name, type identification, and
serial number or other unique identification.
c)
Checks that equipment complies with the
specification
d) The current location, where appropriate.
e) The manufacturer’s instructions, if available,
or reference to their location.
f) dates, results and copies of reports and
certificates of all calibrations, adjustments,
acceptance criteria, and the due date of next
calibration.
g) The maintenance plan, where appropriate
and maintenance carried out todate.
h) Any damage, malfunction, modification or
repair to the equipment.
5.5.6 Procedures to ensure proper functioning
and to prevent contamination or deterioration
be prepared for
 Safe handling
 Transport
 Storage
 Use
 General maintenance
5.5.7 The equipments which are mishandled or
overloaded give suspected results. For such
equipments Isolate to prevent its use
 Mark as out of service.
 Examine effect on previous tests carried out.
 Use “control of Non – conforming work” procedure.
5.5.8 Identifying all equipments with
 Equipment identification number
 Date of calibration
 Due date of calibration
5.5.9 If equipment is sent for outside work,
check the function and calibration status
before the equipment is used again.
 5.5.10 Carry out the intermediate checks
related to calibration status as per procedure.
 5.5.11 The resulting correction factors of
calibration are incorporated in measurements.
 5.5.12 Safeguard the equipments from
invalidating the test / calibration results.

5.6 MEASUREMENT
TRACEABILITY
5.6.1 All equipment should be calibrated before
being put to use.
 Plan the programme for calibration including
system:–
–
–
–
–
–
–
Selection
Use
Calibration
Check
Control
Maintain
Measurement standards reference materials and
measuring equipment.
5.6.2.1 Calibration
 For calibration Laboratories design and create
the calibration program traceable to the
“International System of units (SI)” SISysteme International d unites
 Calibration certificate obtained shall contain:
– Measurement results
– Measurement uncertainty
– Compliance with an identified methodological
specifications.

5.6.2.12 Where calibration cannot be made in
SI Units, traceability to appropriate
measurement standards such as:– Use of certified reference materials provide by
competent supplier.
– Use of specified materials, and or consensus
standards.

Participation in a suitable programme of
interlaboratory comparison is required where
possible.
5.6.2.2 TESTING
5.6.2.2.1 For Testing Laboratory
 Their requirement given in 5.6.2.1 apply
 Equipment used should provide the
uncertainty of measurement needed.
5.6.2.2.2 Traceability of measurements to SI
units is not possible then refer 5.6.2.1.2
5.6.3 Reference standards &
reference materials.
5.6.3.1 Reference Standards
 Programme & procedure for calibration of
reference standard.
 Calibration agencies traceability
 Use reference standards only for calibration.
 Calibrate reference standards before and after
any adjustments.
5.6.3.2 Reference materials.
 Be traceable to SI units of measurements or to
certified reference materials.
 Check the Internal reference material.
5.6.3.3 Intermediate checks
 Carry out the checks of the calibration status of
reference materials, working standards as per the
procedures and schedules.
5.6.3.4 Transport and storage
 Procedure for :–
–
–
–
–


Safe Handling
Transport
Storage
Use of reference standards
Reference materials
To prevent contamination or deterioration
To protect integrity.
5.7 SAMPLING
5.7.1 Sampling Plan and procedure where sampling is
carried out.
 Make available sampling plan at location where sampling
is carried out.
 Sampling plan shall be based on statistical methods.
 Sampling process shall address the factors to be
controlled to ensure validity of the test and calibration
results.
 Sampling is a defined procedure whereby a part of a
substance / material or product is taken to provide for
testing or calibration of a representative sample of the
whole.
Certain specifications gives sampling plan.
 Sampling procedure shall describe

–
–
–
–
Selection
Sampling plan
Withdrawal
Preparation of sample from substance
5.7.2. If customer requires deviations from the
documented sampling plan –
- Record the requirements
- Communicate to the concerned.
5.7.3 Procedure for recording relevant data and
operations relating to sampling.
 Records should include:–
–
–
–
–
Sampling procedure used
Identification of the samples
Environmental conditions.
Diagrams to identify sampling location.
Statistics on which sampling procedure are based.
5.8 HANDLING OF TEST AND
CALIBRATION ITEMS.
5.8.1 Establish the procedure for
 Transportation
 Receipt
 Handling
 Protection
 Storage
 Retention
 Disposal
Of Test / Calibration items.
5.8.2 Establish a system for identifying test/
calibration items.
 Retain identification throughout the life of the
item.
 System of identification be clear to avoid any
confusion w.r.t. Physical, reference records,
or other documents.
 System to include a Subdivision of groups of
items and transfer of items within and from
the laboratory.
5.8.3 On receipt of Test/ Calibration Items: Record the abnormalities or departures from
normal or specified conditions as given in
test/ calibration method.
 If there is doubt about suitability of material
or when non – conforming material is
received or when test/ calibration requirement
are not specified in sufficient detail Consult the customer and record the
discussion.
5.8.4 Procedures and appropriate facilities for avoiding
deterioration, loss or damage to the test/ calibration
item during storage, handling and preparation.
 Follow the handling instructions for the item.
 Maintain, Monitor and record environmental
conditions.
 Arrangements for storage and security.
 When test item are to be returned into service after
testing take special care that they are not damaged or
injured during the handling, testing and storing.
 A Sampling, procedure on storage and transport of
samples be provided.
5.9 ASSURING THE QUALITY OF
TEST AND CALIBRATION RESULTS.
5.9.1 Establish Procedures for monitoring the validity of tests and
calibrations undertaken.

Monitor trends, use statistical techniques.

Monitoring shall be planned and reviewed covering
a)
regular use of certified reference materials and/ or internal quality
control using secondary reference materials.
b)
Participation in interlaboratory comparison or proficiency – testing
programmes.
c)
Replicate tests or calibrations using the same or different methods.
d)
Retesting or recalibration of retained items.
e)
Correlation of results

5.9.2 Quality control data be analyzed and
where they are found to be outside pre –
defined criteria, planned action be taken to
correct the problem and prevent incorrect
results from being reported.
5.10 REPORTING THE RESULTS
5.10.1 Report the results Accuracy
 Clarity
 Unambiguously
 Objectively
Report  Test report or calibration certificates include:
 All the information requested by customer.
 Information required by method used.
Incase of internal customers the results can be reported in
simplified way.
5.10.2 Information required on Test report or Calibration
certificate
a)
A title (e.g. “Test Report” or “Calibration Certificate”)
b)
The name and address of the laboratory, and the location
where the tests and/ or calibration were carried out, if
different from the address of the laboratory.
c)
Unique identification of the test report or calibration
certificate (such as the serial number) and on each page an
identification in order to ensure that the page is recognized
as a part of the test report or calibration certificate, an a
clear identification of the end of the test report or
calibration certificate.
d)
The name and address of the customer.
e)
Identification of the method used.
f)
A description of the condition of and unambiguous
identification of the item(s) tested or calibrated.
g) The date of receipt of the test or calibration item (s) where
this is critical to the validity and application of the results,
and the date(s) of performance of the test or calibration.
h) Reference to the sampling plan and procedures used by the
laboratory or other bodies where these are relevant to the
validity or application of the results.
i)
The test or calibration results with, where appropriate, the
units or measurement.
j)
The name (s), function (s) and signature (s) or equivalent
identification of person(s) authorizing the test report or
calibration certificate.
k)
Where relevant, a statement to the effect that the results
only to the items tested or calibrated.
NOTE 1 Hard copies of test reports and
calibration certificates should also include the
page number and total number of pages.
NOTE 2 It is recommended that laboratories
include a statement specifying that the test
report or calibration certificate shall not be
reproduced except in full, without written
approval of the laboratory.
Test Certificate
5.10.3.1
a)
Deviations from, additions to, or exclusions from the test
method, and information on specific test conditions, such
as environmental conditions.
b)
Where relevant, a statement of compliance/ non –
compliance with requirements and / or specifications.
c)
Where applicable, a statement on the estimated uncertainty
is needed in test reports when it is relevant to the validity
or application of the test results, when a customer’s
instruction so requires, or when the uncertainty affects
compliance to a specification limit.
d)
Where appropriate and needed, opinions and
interpretations
e)
Additional information which may be required by specific
methods, customers or groups of customers.
5.10.3.2
a)
The date of sampling.
b)
Unambiguous identification of the substance, material or
product sampled (including the name of the manufacturer,
the model or type of designation and serial numbers as
appropriate).
c)
The location of sampling, including any diagrams, sketches
or photographs.
d)
A reference to the sampling plan and procedure used.
e)
Details of any environmental conditions during sampling
that may affect the interpretation of the test results.
f)
Any standard or other specification for the sampling
method or procedure, and deviations, additions to or
exclusions from the specification concerned.
5.10.4.1
a) The conditions (e.g. environmental ) under
which the calibrations were made that have
an influence on the measurement results.
b) The uncertainty of measurement and/or a
statement of compliance with an identified
metrological specification or clauses
thereof.
c) Evidence that the measurements are
traceable
5.10.4.2 Calibration certificate should relate only to
the quantities and results of functional tests.



If a statement of compliance with a specification is
made, this shall identify which clauses of the
specifications are met or not met.
When statement of compliance are made, the
records of measurement results and associated
uncertainties be maintained.
5.10.4.3 If instrument for calibration is adjusted or
repaired, the calibration results before and after
adjustment or repair is recorded.
5.10.4.4 A calibration certificate shall not
contain any recommendation on the
calibration interval except when this has been
agreed with the customer. This requirement
may be superseded by legal regulations.
5.10.5 OPINIONS AND
INTERPRETATIONS.

Opinions and Interpretations included in test
report may comprise– An opinion on the statement of compliance / non –
compliance of the results with requirements.
– Fulfillment of contractual requirements.
– Recommendations on how to use the results.
– Guidance to be used for improvement.


Document the basis upon which opinions or
interpretations are made.
Mark these clearly on test reports.
5.10.6 TESTING AND CALIBRATIONS
RESULTS OBTAINED FROM
SUBCONTRACTORS.
Identify these results clearly.
 Obtain results in writing or electronically
 Get the calibration certificate to the
contracting laboratory.

5.10.7 Electronic Transmission of Results
Refer 5.4.7 if reports are send by telephone,
telex, email etc.
5.10.8 Format of reports and certificates
 The format design to include information to
minimize possibility of misunderstanding and
misuse.
 Standardize headings.
 Ensure easy assimilation by reader.
5.10.9 Amendments to test reports and
Calibration certificates.
 Include
the statement.
“Supplement to Test Report (or Calibration
Certificate), Serial No.”
 If a new certificate is to be issued identify it
newly giving reference to original.