CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
Organization Name
PT Provider Name
Division / Dept.
PTP Representative
PTP Ref. No.
Team Leader Name
Reporting Assessor(s)
Name(s)
PTP Scheme Activities
Assessment Type
Name:
Calibration
Pre-assessment
Re-Assessment
PTP self-assessment
This report covers:
Position:
Testing
Initial
Extension
Document review
Assessment No. ( )
Medical
Follow up
Un-Planned
Reporting assessment visit
REQUIREMENTS & COMMENTS
Compliance = C, Non-compliance = NC
Comment below on adequacy of how requirements have been addressed, documented and/or implemented. References to ISO/IEC 17043:2010 are in italics & indicated as Std . The order of assessment need not
follow the order of the checklist. Assessment team are expected to know & have the standard, this worksheet is designed as guidance to prompt detailed recording of the process.
REFER TO ISO/IEC 17043:2010 FOR DETAIL AND FOR CLARIFICATION NOTES.
* Team Leader (TL) determine during the opening meeting which clauses to be covered by assessor and which to covered by TL
** Document review of TL (N/C & Cm) and PTP response will be written in this checklist specified column
Checklist for ISO/IEC 17043:2010
Clause
Standard Requirements
4
4.1
4.1.1
GENERAL REQUIREMENTS
GENERAL
4.2
4.2.1
PERSONNEL
Laboratory self-Assessment
C
NC
TL Document Comments
Does the PT scheme provider have:
- Competence to conduct PT Schemes that it offers?
- Access to expertise for the type of PT test items?
- Is the PT provider or their subcontractor(s) competent in
the measurements of the properties being determined?
(ISO/IEC 17025, ISO 15189 & ISO Guide 34 could be
used to Demonstrate competence)
Does the PT provider have managerial and technical
F1WI4TCL
3.1 / Sep 2019
1/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
Notes in
Std.
4.2.2
4.2.3
4.2.4
4.2.5
4.2.6
personnel with the necessary:
- Authority?
- Resources?
Technical competence?
Has the PT provider defined the minimum levels of:
- Qualifications?
- Experience?
Necessary for key positions.
personnel employed by, or under contract to the provider?
Where contracted or other personnel are used are they:
- Supervised?
- Competent?
Able to work in compliance of the management system?
Are the PT authorize specific personnel to:
a) select appropriate PT items;
b) plan PT schemes;
c) perform particular types of sampling;
d) operate specific equipment;
e) conduct measurements to determine stability and
homogeneity, as well as assigned values and associated
uncertainties of the measurands of the PT item;
f) prepare, handle and distribute PT items;
g) operate the data processing system;
h) conduct statistical analysis;
i) evaluate the performance of PT participants;
j) give opinions and interpretations; and
k) authorize the issue of PT reports.
Are up-to-date records readily available of:
- Relevant authorizations?
- Competence?
- Educational & Professional qualifications?
- Training?
- Skills?
- And experience?
For all personnel, including contracted personnel
Do the records include the date on which competence
was assessed and confirmed?
- Has the provider formulated the objectives for each staff
member with respect to, education, training and skills?
- Does the provider have both a policy and procedure for
F1WI4TCL
3.1 / Sep 2019
2/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
4.2.7
4.3
4.3.1
4.3.2
4.3.3
4.3.4
identifying training needs, and providing training of
personnel?
Is the training program relevant to both present and
anticipated needs of the PT provider?
Have the staff been trained in order to ensure the
competent:
- Performance of measurements?
- Operation of equipment?
- Any other activity that could affect the quality of the
scheme?
Has the effectiveness of training activities been
evaluated?
EQUIPMENT, ACCOMMODATION AND ENVIRONMENT
Are the proficiency testing provider ensure that there is
appropriate accommodation for the
operation of the proficiency testing scheme.
Is this includes:
facilities and equipment, manufacturing, handling,
calibration, testing, storage and dispatch, for data
processing, for communications, and for retrieval of
materials and records.
- Are the environmental conditions conductive to the
operation of the PT Scheme?
- Are the environmental conditions acceptable for work
undertaken at sites other than the permanent facilities?
- If work is undertaken by a subcontractor are the
environmental conditions acceptable?
- Has the PT provider documented the technical
requirements for the environmental conditions that could
affect the PT scheme?
- Is access to areas affecting the quality of the PT
scheme controlled?
- Has the PT provider identified areas where
environmental conditions could influence the
- results, including any Testing and Calibration?
(including relevant specifications and measurement
procedures)
- Where relevant does the provider control & monitor
these conditions?
- Where necessary does the provider have records of the
F1WI4TCL
3.1 / Sep 2019
3/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
4.3.5
4.3.6
4.4
4.4.1
4.4.1.1
4.4.1.2
4.4.1.3
monitoring of the environmental conditions?
- Have provisions been made to cease testing activities
when the environmental conditions jeopardize the
quality?
(Note: Environmental conditions could include biological
sterility, dust, electromagnetic disturbances, radiation,
humidity, electrical supply, temperature, sound and
vibration levels)
- Is there effective separation between incompatible
activities?
- Are the methods, procedures and equipment used to
confirm content, homogeneity and stability suitably
validated and maintained?
DESIGN OF PROFICIENCY TESTING SCHEMES
PLANNING
Has the PT provider ‘prescribed procedures’ for all those
processes which affect the quality
of the PT scheme?
Has the PT provider subcontracted the planning?
Has the provider documented a plan before the commencement of
a scheme?
Does the plan address:
- The objectives?
- The purpose?
- The basic design?
Does the plan include the following information
a) Name & address of the PT provider?
b) Name, address and affiliation of the coordinator?
c) Activities subcontracted & details of subcontractors?
d) Criteria for participation?
e) The number and type of expected participants?
f) Measurand(s) or characteristics of interest?
g) A range of values or characteristics expected for the item?
h) The potential major sources of error?
i) Requirements for production, QC, storage & distribution?
j) Reasonable precautions to prevent collusion, or falsification of
results?
Procedures to be employed if collusion and/or falsification is
F1WI4TCL
3.1 / Sep 2019
4/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
4.4.1.4
4.4.1.5
4.4.2
4.4.2.1
4.4.2.2
suspected?
k) Description of information to be provided to participants?
A time schedule for the phases of the PT scheme?
l) For continuous schemes the frequency or dates of distribution,
deadlines to returns?
m) Info on methods/procedures to prepare or perform the tests or
measurements?
n) Procedures for testing homogeneity, stability, and where
relevant biological viability?
o) Standardized reporting format for participants?
p) Detailed description of statistical analysis to be employed?
q) The metrological traceability & uncertainty where relevant?
r) Criteria for evaluation of performance?
s) Information on data, interim reports or information to sent to
participants?
t) The extent to which results and conclusions will be made
public?
u) Actions to be taken if PT item/s is lost or damaged?
Has the PT provider access to the necessary technical expertise?
(relevant field testing, calibration, sampling or inspection as well
as statistics)
(Note this may be achieved by establishing an advisory group)
Where appropriate has technical expertise been used to determine
matters such as:
a) Planning requirements?
b) Identification and resolution of difficulties in the preparation
of homogeneous test items or a stable assigned value?
c) Preparation of detailed instructions for participants?
d) Comments on previously experienced difficulties?
e) Advise on evaluating performance?
f) Overall comments on performance, groups of participants, or
individual performance?
g) Advice to participants?
h) Responding to participant feedback?
i) Planning or contribution to technical meetings with participants
Preparation of PT Test Items
- Has the PT provider written procedures for preparation of test
items in accordance with the plan described in 4.4.1?
Have these procedures been implemented?
- Has the PT provider written procedures for preparation of test
F1WI4TCL
3.1 / Sep 2019
5/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
4.4.2.3
4.4.2.4
4.4.3
4.4.3.1
4.4.3.2
4.4.3.3
4.4.3.4
4.4.3.5
4.4.3.6
4.4.4
4.4.4.1
items in accordance with the plan described in 4.4.1?
Have these procedures been implemented?
- Are PT Items chosen to match in matrix, measurand, and
concentration (as closely as practicable) to items encountered
in routine testing or calibration?
Has the PT provider included instructions for the preparation,
packaging & transport of the test item, where participants are
required to prepare and/or manipulate the PT test item?
Homogeneity and Stability,
Have criteria for suitable homogeneity and stability been
established?
- Are documented procedures available for the assessment of
Homogeneity and Stability?
- Where applicable do these procedures include appropriate
statistical design?
Is a statistically random process used to select a representative
number of PT items for homogeneity testing?
Is homogeneity testing performed on items that have been
packaged in their final form
prior to distribution?
If PT items have demonstrated to be sufficiently stable to ensure
that they will not undergo any significant change throughout the
conduct of the proficiency testing, including storage and
transport conditions?
If not possible, Is the stability had been quantified and considered
as an additional component of the measurement uncertainty
associated with the assigned value of the proficiency test item,
and/or taken into account in the evaluation criteria?
If PT items/material is retained for future use, are the property
values reconfirmed?
In instances where Homogeneity and stability testing is not
feasible can the provider demonstrate
that procedures followed are sufficient for the purposes of PT
Testing?
Statistical Design
Have statistical designs been developed to meet the objectives of
the scheme? (based on the
nature of the data, statistical assumptions, errors, and number of
results)
F1WI4TCL
3.1 / Sep 2019
6/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
4.4.4.2
4.4.4.3
4.4.4.5
4.4.5.1
4.4.5.2
4.4.5.3
4.4.5.4
4.4.5.5
- Has the provider documented the statistical design and data
analysis methods?
(used to identify the assigned value, and evaluate participant
results)
- Can the provider show that statistical assumptions are
reasonable?
Are the statistical analyses carried out in accordance with
prescribed procedures?
Has the PT provider given careful consideration to The accuracy
and measurement uncertainty:
a) For each measurand?
b)The minimum number of participants, necessary to meet the
statistical design?
c) Significant figures / decimal places to be reported?
d) The number of PT items to be tested/measured?
e) The procedure to establish the SD or other evaluation criteria?
f) Procedures to identify identify and handle outliers?
g) Procedures to evaluate values excluded from stat analysis?
h) Where appropriate, the objectives to be met for the design and
frequency of PT rounds?
Assigned Values
- Has the PT provider documented the procedure for
determining the assigned value?
Does the procedure take into account metrological traceability
including uncertainty, in order to demonstrate that the PT is fit for
purpose?
- For Calibration PT is the assigned value metro logically
traceable?
- Other than Calibration, has the relevance of metrological
stability and uncertainty been considered?
- If a consensus value is used as the assigned value, has the
provider documented the reason for this choice, and has the
uncertainty of the assigned value been evaluated?
- Has the PT provider a policy on the disclosure of the assigned
value?
- Does the policy ensure that early disclosure will not give
advantage?
4.5
Choice of Method or Procedure
4.5.1
Has the PT provider allowed participants to use the
F1WI4TCL
3.1 / Sep 2019
7/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
4.5.2
4.6
4.6.1
4.6.1.1
test/measurement procedure of their choice?
(Note the PT provider may require the use of a specific procedure
depending on the design of the scheme)
Where the PT provider allows for the use of a method chosen by
the participant, has the provider the following:
a) a policy and procedure for the comparison of results from
different methods?
b) an awareness of the technical equivalence of methods, and
assess results accordingly?
Operation of proficiency testing schemes
Instructions for Participants
- Has the PT provider gave participants' sufficient prior notice
before sending PT items, providing the date on which the
proficiency test items are likely to arrive or to be dispatched,
unless the design of the proficiency testing scheme makes it
inappropriate to do so?
- Has PT provider shall gave detailed documented instructions to
all participants including:
a) the necessity to treat proficiency test items in the same manner
as the majority of routinely tested samples (unless there are
particular requirements of the proficiency testing scheme which
require departure from this principle);
b) details of factors which could influence the testing or
calibration of the proficiency test items, e.g. the nature of the
proficiency test items, conditions of storage, whether the
proficiency testing scheme is limited to selected test methods, and
the timing of the testing or measurement;
c) detailed procedure for preparing or conditioning, or both
preparing and conditioning, of the proficiency test items before
conducting the tests or calibrations;
d) any appropriate instructions on handling the proficiency test
items, including any safety requirements;
e) any specific environmental conditions for the participant to
conduct tests or calibrations, or both, and, if relevant, any
requirement for the participants to report relevant environmental
conditions during the time of the measurement;
f) specific and detailed instructions on the manner of recording
and reporting test or measurement results and associated
uncertainties. If the instructions include reporting of the
F1WI4TCL
3.1 / Sep 2019
8/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
uncertainty of the reported result or measurement, this shall
include the coverage factor and, whenever practicable, the
coverage probability;
4.6.2
Proficiency Testing Items Handling and Storage
4.6.2.1
Has the PT provider ensured that PT items are identified and
segregated from the time of preparation to distribution?
­ Are secure storage areas available for the PT items?
- Are procedures defined for dispatch, and receipt of PT items
from such areas?
When appropriate, is the condition of PT items, chemicals and
materials assessed during storage to detect deterioration?
Where hazardous PT items, chemicals and materials are used can
the provider ensure their safe handling, decontamination and
disposal?
4.6.2.2
4.6.2.3
4.6.2.4
4.6.3
6.4.3.1
4.6.3.2
4.6.3.3
4.6.3.4
4.6.3.5
4.7
4.7.1
4.7.1.1
4.7.1.2
4.7.1.3
4.7.1.4
Packaging, labelling and distribution of proficiency test items
Does packaging and labeling of PT items comply with relevant
National, regional and International safety and transport
requirements?
- Has the PT provider specified the relevant environmental
conditions for the transport of PT items?
- Where relevant, has the provider monitored the environmental
conditions during transport?
If participants are required to transport the PT item to the next
participant, are detailed instructions available?
Are the labels designed to remain intact, and the writing legible
throughout the PT testing round?
Has the PT provider a procedure to confirm the delivery of PT
test items?
Data analysis and evaluation of proficiency testing scheme results
Data Analysis and Records
- Is all data processing equipment and software validated?
- Does the maintenance include a back-up process and recovery
plan?
- Are records available of maintenance and operational checks?
Are procedures available to ensure the validity of data entry, data
transfer, statistical analysis and reporting?
Does the data analysis produce summary and performance
statistics consistent with the design of the scheme?
Are robust statistical techniques used to minimize the effect of
F1WI4TCL
3.1 / Sep 2019
9/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
4.7.1.5
4.7.1.6
4.7.2
4.7.2.1
4.7.2.2
4.8
4.8.1
4.8.2
outliers on summary statistics?
Does the PT provider have procedures for dealing with
miscalculations, transpositions and other gross errors?
Does the PT provider have documented criteria and procedures to
manage PT items unsuitable due to inhomogeneity, instability,
damage or contamination?
Evaluation of performance
Are documented methods available for the evaluation of
performance, that meet the purpose of
the scheme?
Where appropriate, expert comment on performance with respect
to:
a) Performance against expectation, taking measurement
uncertainties into account?
b) Variation between participants?
c) Variation between methods/procedures?
d) Possible sources of error, improvement suggestions?
e) Advice and educational feedback?
f) Situations where performance commentary is not possible?
g) Suggestions, recommendations, general comments?
h) Conclusions
Reports
Are PT provider reports clear and comprehensive and include
data covering the results of all participants, together with an
indication of the performance of individual participants?
Is the authorization of the final report been subcontracted?
Are Reports include the following, unless it is not applicable or
the PT provider has valid reasons for not doing so:
a) the name and contact details for the proficiency testing
provider;
b) the name and contact details for the coordinator;
c) the name(s), function(s), and signature(s) or equivalent
identification of person(s) authorizing the report;
d) an indication of which activities are subcontracted by the
proficiency testing provider;
e) the date of issue and status (e.g. preliminary, interim, or final)
of the report;
f) page numbers and a clear indication of the end of the report;
g) a statement of the extent to which results are confidential;
F1WI4TCL
3.1 / Sep 2019
10/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
4.8.3
4.8.4
4.8.5
h) the report number and clear identification of the proficiency
testing scheme;
i) a clear description of the proficiency test items used, including
necessary details of the proficiency test item's preparation and
homogeneity and stability assessment;
j) the participants' results;
k) statistical data and summaries, including assigned values and
range of acceptable results and graphical displays;
l) procedures used to establish any assigned value;
m) details of the metrological traceability and measurement
uncertainty of any assigned value;
n) procedures used to establish the standard deviation for
proficiency assessment, or other criteria for evaluation;
o) assigned values and summary statistics for test
methods/procedures used by each group of participants
(if different methods are used by different groups of participants);
p) comments on participants' performance by the proficiency
testing provider and technical advisers;
q) information about the design and implementation of the
proficiency testing scheme;
r) procedures used to statistically analysis the data;
s) advice on the interpretation of the statistical analysis; and
t) comments or recommendations, based on the outcomes of
the proficiency testing round.
- Are reports made available within a planned timescale?
- In sequential schemes, with long turn-around times, are
preliminary results made available?
Does the PT provider have a policy regarding the use of reports
by participants, individuals
or organizations?
When necessary to issue a new or amended PT report does it
include:
- A unique identification?
- A reference to the original report?
- A statement concerning the reason for amendment or
replacement?
4.9
Communication with participants
4.9.1
Has the PT provider made detailed information available
about the scheme that includes:
a) Details of the scope of the PT scheme?
F1WI4TCL
3.1 / Sep 2019
11/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
4.9.2
4.9.3
4.9.4
4.9.5
b) Fees for participation?
c) Eligibility criteria for participation?
d) Confidentiality arrangements?
e) Details on the application process?
Are participants notified promptly of any changes in the PT
scheme design or operation?
- Are documented appeal procedures available?
- Is the appeals process communicated to participants?
Are records of communication with participants available?
Does the PT provider issue statements of participation
and/or performance, and do they include sufficient detail
not to be misleading?
4.10
Confidentiality
4.10.1
Is the identity of participants confidential?
(Unless the participant has waived this confidentiality)
Is all information provided the participants treated as
confidential?
When the results are made available to an interested 3rd
party (accreditation body, etc) are participants made aware
of this prior to participation?
When a regulatory authority requires PT results to be
issued directly to them, are affected participants notified in
writing?
4.10.2
4.10.3
4.10.4
5
5.1
5.1.1
5.1.2
5.1.3
5.1.4
MANAGEMENT REQUIREMENTS
Organization: How are the following addressed/
implemented?
The provider, or the organization of which it is part, shall
be an entity that can be legally identifiable and
accountable.
Is the PT scheme conducted in a manner to meet the
requirements of:
­ The ISO/IEC 17043 International Standard?
­ The participants?
­ Regulatory or accreditation bodies?
Does the management system cover it’s permanent
facilities, and temporary facilities?
If the provider is part of a organization with other activities
­ Are the responsibilities of Key personnel identified?
­ Have potential conflicts of interest been identified?
F1WI4TCL
3.1 / Sep 2019
12/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
­ Where potential conflicts exist have procedures been
5.1.5
5.1.6
5.2
5.2.1
5.2.2
implemented to ensure the impartiality of the PT
scheme?
Has the PT provider:
a) Management & Technical personnel with the
resources and authority necessary to carry out
their duties?
b) Arrangements to ensure that personnel are free
from undue financial, commercial, and other
pressures that may affect the quality of their work?
c) Policies and procedures to protect participant’s
confidential information?
d) Policies and procedures to avoid activities that
may affect confidence in its competence,
impartiality, judgment and integrity?
e) A defined organization structure, showing its place
in the organization, and relationship between
Quality, Technical operations, and support
services?
f) Specified the responsibility, authority, and
interrelationships or all personnel?
g) Ensured that personnel are aware of the relevance
and importance of their activities and the
contribution to the overall objectives?
h) Provided adequate supervision particularly for
trainees?
i) Technical management responsible for technical
activities and resources relevant to the technical
field including statistics?
j) Appointed a Quality Manager, having access to
the highest level of management?
k) Appointed deputies for key managerial positions?
Are appropriate communication process established within
the organization and does communication include the
effectiveness of the management system?
Management system
Has the provider established, implemented and maintained
an appropriate management system?;
­ Has the provider defined and documented its policies,
programmes, procedures and instructions?
F1WI4TCL
3.1 / Sep 2019
13/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
5.2.3
5.2.4
5.2.5
5.2.6
5.2.7
5.2.8
­ Is the documentation communicated to, understood by
available to, and implemented by appropriate personnel?
­ Is the management systems policy, including a quality
policy statement defined in a quality manual?
­ Are the overall objectives established and reviewed
during the management review?
­ Is the Quality policy statement issued under the authority
of top management?
­ Does the Quality Policy Statement include:
a) The management’s commitment to Quality of its PT
services?
b) The management’s statement of Service?
c) A requirement for personnel to familiarize themselves
with the quality documentation, policies and
procedures?
d) A commitment from management to comply with
ISO/IEC 17043 and to continuously improve the
system?
Is there evidence of commitment of top management to
develop and improve the management system?
Has top management communicated the importance of
meeting customer, statutory and regulatory requirements?
Does the Quality manual refer to supporting procedures,
and does it include an outline of the management system
documentation?
Are the roles and responsibilities of the Technical and
Quality manager defined in the quality manual?
Do top management ensure the integrity of the
management system when changes to the management
system are planned or implemented?
5.3
5.3.1
DOCUMENT CONTROL
5.3.2
5.3.2.1
Document approval and issue
­ Has the provider established procedures to control all
documents that are part of the management system?
­ Does this include regulations, standards, normative
documents, scheme protocols, test and/or calibration
methods, drawings, software specifications, instructions
and manuals?
­ Are all documents forming part of the management
F1WI4TCL
3.1 / Sep 2019
14/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
5.3.2.2
5.3.2.3
5.3.3
5.3.3.1
5.3.3.2
5.3.3.3
5.3.3.4
5.4
5.4.1
5.4.2
5.4.3
5.4.4
system reviewed, approved and authorized prior to
issue?
­ Is a Master List of all documentation available?
­ Does the master list indicate the revision, and distribution
of the documents?
Do the adopted procedures ensure:
a) Authorized editions are available where necessary?
b) Documents are periodically reviewed?
c) Obsolete documents are promptly removed from use?
d) Obsolete documents retained are suitably marked?
Document Changes
­ Are changes to documents reviewed and approved by
the same original function?
­ Do the designated approval personnel have access to
pertinent background information?
Where practicable has amended text been identified?
­ If hand changes are permitted, is there a defined
procedure for this?
­ Are hand marked amendments initialed and dated?
­ Is a revised document issued as soon as practicable?
Are procedures available describing how documents
maintained in computerized systems are amended and
controlled?
REVIEW OF REQUESTS, TENDERS AND CONTRACTS
Has the provider established policies and procedures for
the review of requests, tenders and contracts?
Do the reviews ensure that:
a) The requirements including test or calibration methods,
the equipment and the PT Test item defined,
documented and understood?
b) The PT provider has the capability and resources to
meet the requirements?
c) The PT scheme is technically appropriate?
Are records of the review including pertinent discussions
with the customer available?
Does the review include all aspects of the request,
including any work subcontracted?
Are participants informed of any changes in the contract, or
agreed scheme design?
F1WI4TCL
3.1 / Sep 2019
15/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
5.4.5
Is the same review process followed when the contract is
amended, and the PT scheme is underway?
5.5
5.5.1
SUBCONTRACTING SERVICES
5.5.2
5.5.3
5.5.4
5.5.5
5.5.6
5.6
5.6.1
5.6.2
5.6.3
5.6.4
5.7
5.7.1
If the provider has subcontracted work, have they
demonstrated the subcontractor’s competence for the
assigned tasks?
Confirm that the Provider has not subcontracted the
planning, evaluation, and authorization of the report.
Has the provider informed, in writing, the participants of
services that are, or may be subcontracted?
Is the provider responsible for the subcontracted work?
­ Is a register available of all subcontractors used?
­ Are records available of the competence of
subcontractors used?
PURCHASING SERVICES AND SUPPLIES
­ Has the provider policies and procedures for the
selection of services and supplies that can affect the
quality of the PT scheme?
­ Are procedures available for the purchase, reception and
storage of reagents, PT test items, reference materials,
and other relevant consumables?
­ Are purchase supplies, equipment and materials
inspected (or verified) prior to being taken into use?
­ Are records available of this inspection/verification
available?
­ Do the purchase orders include data describing the
services or services ordered?
­ Are the purchasing documents (orders) reviewed and
approved for technical content prior to release?
­ Are the suppliers of critical supplies and services
evaluated?
­ Is a list of approved suppliers available?
­ Are records available of the evaluations of suppliers and
services?
SERVICE TO THE CUSTOMER
­ Is the provider willing to cooperate with participants in
monitoring the provider’s performance?
­ Has the provider assured the confidentiality of other
participants?
F1WI4TCL
3.1 / Sep 2019
16/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
5.7.2
­ Has the provider sought feedback from its customers
(positive or negative)?
­ Is the feedback analyzed and used to improve the
management system, PT schemes, and service?
5.8
COMPLAINTS AND APPEALS
­ Has the provider a policy and procedure for the
resolution of complaints and appeals?
Are records available of all complaints, appeals,
investigations and corrective action taken by the provider?
5.9
5.9.1
5.9.2
5.10
CONTROL OF NON-CONFORMING WORK
­ Does the provider have policies and procedures for
cases where their activities do not conform to their own
procedures, or agreed customer requirements?
­ Does the policy and procedure ensure:
a) The responsibility and authority for managing
nonconforming work, including actions to be taken when
identified? (including halting work and/or withholding
reports)
b) An evaluation of the non-conforming work?
c) A decision on immediate action, and acceptability of
nonconforming work?
d) Participants are informed, reports already sent recalled?
e) The responsibility for resumption of work defined?
In cases where the non-conforming work could reoccur, has
the corrective action procedure been followed?
IMPROVEMENT
Has the provider used the quality policy and objectives,
audit results, analysis of data, corrective & preventive
actions and management review to improve the
effectiveness of the management system?
5.11
5.11.1
5.11.2
5.11.3
5.11.3.1
CORRECTIVE ACTIONS
Has the provider policy and procedure for the
implementation of corrective action when non-conforming
work or deviations for procedures are identified?
Cause analysis
Does the procedure start with an investigation to determine
the root cause(s)?
Selection and implementation of corrective actions
Has the provider selected corrective action on the basis
F1WI4TCL
3.1 / Sep 2019
17/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
5.11.3.2
5.11.3.3
5.11.4
5.11.5
5.12
5.12.1
5.12.2
5.13
5.13.1.1
5.13.1.2
5.13.1.3
5.13.1.4
5.13.2
5.13.2.1
that the action is the most likely to eliminate the problem
and prevent recurrence?
Is the corrective action appropriate to the extent and risk of
the problem?
Has the provider documented and implemented required
changes as a result of the investigation?
Has the provider monitored the corrective action(s) to
ensure that it is effective?
Has the provider implemented additional internal audits
where doubt has been cast of the compliance of the
provider with their own policies and procedures?
PREVENTATIVE ACTION
Has the provider identified areas for improvement or
potential sources of non-conforming work?
Where applicable have action plans been developed,
implemented and monitored?
Does the procedure for preventative action include the
initiation of actions, and implementation of controls to
ensure that the action is effective?
CONTROL OF RECORDS
Does the provider have procedures for the identification,
indexing, access, filing, storage, maintenance and disposal
of records?
Do the records include Internal Audit records, Management
review reports, corrective and preventative actions?
Are records
­ Legible?
­ Readily retrievable?
­ Stored in a suitable environment?
Has the retention time been established?
Are records kept secure and confidential?
­ Is unauthorized access to electronic records prevented?
Technical Records
Has the provider records of technical data related to each
PT round that includes:
a) Results for homogeneity and stability testing?
b) Instructions to participants?
c) participants' original responses;
d) collated data for statistical analysis;
F1WI4TCL
3.1 / Sep 2019
18/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
5.13.2.2
5.13.2.3
5.14
5.14.1
5.14.2
5.14.3
5.14.4
5.15
5.15.1
e) information required for reports (see 4.8); and
f) final reports (summary or individual, or both).
Is data entry, checking and calculations recorded at the
time they are made, and are they identifiable to the
personnel responsible?
When mistakes occur in records and alterations are made,
actions shall be taken to:
a) Identify the change and date of alteration?
b) Avoid loss of the original data?
c) Identify the person making the alteration?
INTERNAL AUDITS
­ Have periodic internal audits been conducted?
­ Is a predetermined schedule and procedure available for
Internal audits?
­ Does the internal audit address all of the elements of the
management system?
­ Is the Quality Manager responsible for planning and
organizing the internal audits?
­ Are the internal audits conducted by trained and qualified
personnel?
When the audit findings cast doubt on the effectiveness of
operations, correctness of PT items, procedures, statistical
analysis, and data presentation, has corrective action been
taken, and/or participants notified?
Have the audit findings and corrective action taken been
recorded?
Have follow-up audit activities verified and recorded the
implementation and effectiveness of any corrective actions
taken.
MANAGEMENT REVIEWS
­ Has a management review been conducted against a
predetermined schedule and procedure?
­ Was a decision reached on the continued suitability of
the system?
­ Was a decision made to implement changes and
improvements?
Did the review take into account:
a) the suitability of policies and procedures?
b) Reports from management and supervisory
F1WI4TCL
3.1 / Sep 2019
19/20
CAB Self-Assessment & Document Review
according to ISO/IEC17043:2010
5.15.2
personnel?
c) Internal audits?
d) Corrective & preventative actions?
e) Assessments by external bodies?
f) Changes in work type and volume of work?
g) Feedback from customers, participants & advisory
groups?
h) Complaints and appeals?
i) Recommendations for improvement?
j) Other relevant factors including training and
resources?
Are actions arising from management reviews
recorded, and discharged in an appropriate time
scale?
Lab representative (for lab selfassessment)
General comments for document
review (Filled by TL)
Name:
Sign:
Date:
Name:
Sign:
Date:
Recommendations for document
review (Filled by TL)
Team Leader (TL)
F1WI4TCL
3.1 / Sep 2019
20/20