F 90-03

MANAGEMENT CHECKLIST FOR PROFICIENCY TESTING

SCHEMES INCORPORATING:
ISO/IEC 17043:2010 Conformity Assessment General
Requirements for Proficiency Testing

Scheme provider: SANAS No:

Management Assessor:
Representative:

This report covers the following:

Document Implementation on Document Review Other
Review only Site Visit only and Site Visit

REQUIREMENTS AND COMMENTS Compliance = C, Non-compliance = NC, Not applicable = NA C

NB: Indicate WHAT has been checked and HOW requirements have been implemented. The order of NC
assessment need not follow the order of the checklist. Assessors are expected to know & have the NA
standard, this checklist is designed as guidance to prompt detailed recording of the process.
REFER TO ISO/IEC 17043:2010 FOR DETAIL AND FOR CLARIFICATION NOTES.
ISO/IEC ILAC G13: Requirement
17043:2010 2000
5.1 ORGANISATION
5.1.1 Is the PT provider or their organization legally identifiable?
5.1.2 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?
5.1.3 Does the management system cover its permanent facilities, and
temporary facilities?
5.1.4 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?
Where potential conflicts exist have procedures been implemented
to ensure the impartiality of the PT scheme?
Comments

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ISO/IEC ILAC G13: Requirement

17043:2010 2000
5.1.5 2.2.2 Has the PT provider
a) a) Management & Technical personnel with the resources and
authority necessary to carry out their duties?
b) b) Arrangements to ensure that personnel are free from undue
financial, commercial, and other pressures that may affect the
quality of their work?
c) c) Policies and procedures to protect participants confidential
information?
d) d) Policies and procedures to avoid activities that may affect
confidence in its competence, impartiality, judgement and
integrity?
e) e) A defined organization structure, showing its place in the
organization, and relationship between Quality, Technical
operations, and support services?
f) 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?
g) i) Technical management responsible for technical activities and
resources relevant to the technical field including statistics?
h) j) Appointed a Quality Manager, having access to the highest level
of management?
i) k) Appointed deputies for key managerial positions?
Comments

5.1.6 Are appropriate communication process established within the

organization and does communication include the effectiveness of the
management system?
Comments

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ISO/IEC ILAC G13: Requirement

17043:2010 2000
5.2 MANAGEMENT SYSTEM
5.2.1 2.1.3 Has the provider established, implemented and maintained an
appropriate management system?
5.2.2 2.1.3 Has the provider defined and documented its policies,
programmes, procedures and instructions?
Is the documentation communicated to, understood by available
to, and implemented by appropriate personnel?
5.2.3 2.1.2 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 managements commitment to Quality of its PT
services?
b) The managements 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?
5.2.4 Is there evidence of commitment of top management to develop and
improve the management system?
5.2.5 Has top management communicated the importance of meeting
customer, statutory and regulatory requirements?
5.2.6 Does the Quality manual refer to supporting procedures, and does it
include an outline of the management system documentation?
5.2.7 Are the roles and responsibilities of the Technical and Quality manager
defined in the quality manual?
5.2.8 Do top management ensure the integrity of the management system
when changes to the management system are planned or implemented?
Comments

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5.3 DOCUMENT CONTROL

5.3.1 General
ISO/IEC ILAC G13: Requirement
17043:2010 2000
5.3.1 2.3.1 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?
5.3.2 Document approval and issue
5.3.2.1 2.3.2.1 Are all documents forming part of the management 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?
5.3.2.2 2.3.2.2 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?
Comments

5.3.3 Document Changes

5.3.3.1 Are changes to documents reviewed and approved by the same
original function?
Do the designated approval personnel have access to pertinent
background information?
5.3.3.2 Where practicable has amended text been identified?
5.3.3.3 If hand changes are permitted, is there a defined procedure for
this?
Are hand marked amendments initialled and dated?
Is a revised document issued as soon as practicable?
5.3.3.4 Are procedures available describing how documents maintained in
computerized systems are amended and controlled?
Comments

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ISO/IEC ILAC G13: Requirement

17043:2010 2000
5.4 REVIEW OF REQUESTS, TENDERS AND CONTRACTS
5.4.1 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?
5.4.2 Are records of the review including pertinent discussions with the
customer available?
5.4.3 Does the review include all aspects of the request, including any work
subcontracted?
5.4.4 Are participants informed of any changes in the contract, or agreed
scheme design?
5.4.5 Is the same review process followed when the contract is amended, and
the PT scheme is underway?
Comments

5.5 SUBCONTRACTING SERVICES

5.5.1 If the provider has subcontracted work, have they demonstrated the
subcontractors competence for the assigned tasks?
5.5.2 Confirm that the Provider has not subcontracted the planning, evaluation,
and authorization of the report.
5.5.3 Has the provider informed, in writing, the participants of services that are,
or may be subcontracted?
5.5.4 Is the provider responsible for the subcontracted work?
5.5.5 Is a register available of all subcontractors used?
Are records available of the competence of subcontractors used?
Comments

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ISO/IEC ILAC G13: Requirement

17043:2010 2000
5.6 PURCHASING SERVICES AND SUPPLIES
5.6.1 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?
5.6.2 Are purchase supplies, equipment and materials inspected (or
verified) prior to being taken into use?
Are records available of this inspection/verification available?
5.6.3 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?
5.6.4 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?
Comments

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ISO/IEC ILAC G13: Requirement

17043:2010 2000
5.7 SERVICE TO THE CUSTOMER
5.7.1 Is the provider willing to cooperate with participants in monitoring
the providers performance?
Has the provider assured the confidentiality of other participants?
5.7.2 Has the provider sought feedback from its customers (positive or
negative)?
Is the feedback analysed and used to improve the management
system, PT schemes, and service?
5.8 COMPLAINTS AND APPEALS
2.7 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?
Comments

5.9 CONTROL OF NON-CONFORMING WORK

5.9.1 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 non-
conforming 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 non-
conforming work?
d) Participants are informed, reports already sent recalled?
e) The responsibility for resumption of work defined?
5.9.2 In cases where the non-conforming work could reoccur, has the corrective
action procedure been followed?
Comments

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ISO/IEC ILAC G13: Requirement

17043:2010 2000
5.10 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 CORRECTIVE ACTIONS
5.11.1 Has the provider policy and procedure for the implementation of
corrective action when non-conforming work or deviations for procedures
are identified?
5.11.2 Does the procedure start with an investigation to determine the root
cause(s)?
5.11.3.1 Has the provider selected corrective action on the basis that the action is
the most likely to eliminate the problem and prevent recurrence?
5.11.3.2 Is the corrective action appropriate to the extent and risk of the problem?
5.11.3.3 Has the provider documented and implemented required changes as a
result of the investigation?
5.11.4 Has the provider monitored the corrective action(s) to ensure that it is
effective?
5.11.5 Has the provider implemented additional internal audits where doubt has
been cast of the compliance of the provider with their own policies and
procedures?
5.12 PREVENTATIVE ACTION
5.12.1 Has the provider identified areas for improvement or potential sources of
non-conforming work?
Where applicable have action plans been developed, implemented and
monitored?
5.12.2 Does the procedure for preventative action include the initiation of
actions, and implementation of controls to ensure that the action is
effective?
Comments

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ISO/IEC ILAC G13: Requirement

17043:2010 2000
5.13 CONTROL OF RECORDS
5.13.1.1 2.11.1.1 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?
5.13.1.2 Are records
Legible?
2.11.1.2 Readily retrievable?
Stored in a suitable environment?
Has the retention time been established?
5.13.1.3 2.11.1.3 Are records kept secure and confidential?
5.13.1.4 2.11.1.4 Are records stored electronically protected and backed up
according to procedure?
Is unauthorized access to electronic records prevented?
5.13.2.1 2.11.2 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) d) e) & f) See vertical Checklist F 123
5.13.2.2 Is data entry, checking and calculations recorded at the time they are
made, and are they identifiable to the personnel responsible?
5.13.2.3 Where mistakes have occurred and alterations made do these
a) Identify the change and date of alteration?
b) Avoid loss of the original data?
c) Identify the person making the alteration?
Comments:

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ISO/IEC ILAC G13: Requirement

17043:2010 2000
5.14 INTERNAL AUDITS
5.14.1 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?
5.14.2 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?
5.14.3 Have the audit findings and corrective action taken been
recorded?
Comments

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ISO/IEC ILAC G13: Requirement

17043:2010 2000
5.15 MANAGEMENT REVIEWS
5.15.1 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 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?
5.15.2 Are actions arising from management reviews recorded, and discharged
in an appropriate time scale?
Comments

Date: ..

Lead Assessor

Name: Signature:

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