ISO/IEC 17025 CHECKLIST

WITH

INTERPRETIVE COMMENTS

October 2005

This document, based on the Laboratory Assessment Worksheet, includes only those clauses of
ISO/IEC 17025 where clarification or interpretation has been sought. The interpretive comments are included
in the 'Comments' column against the relevant clause(s).

These comments are a result of discussions held by NATA staff and are provided as a guide only, as each
facility's system is looked at in terms of its needs and situation.

Issued: Oct 2005 Page 1 of 8

Reviewed: January 2015
4 MANAGEMENT REQUIREMENTS
4.1 Organisation
CLAUSE REQUIREMENT
Undue pressure ensure arrangements are in place so that
4.1.5b management and personnel are free
from internal and external commercial,
financial and other pressures that might
adversely affect the quality of their work
Operational ensure the facility has policies and
integrity procedures to avoid involvement in
4.1.5d activities that compromise the
confidence in its competence,
impartiality, judgement or operational
integrity
4.2 Management System
Policies and document policies and procedures as a
procedures management system to ensure quality of
4.2.1 all work and that they are communicated,
available, understood and implemented
Quality policy ensure the quality policy statement is
statement issued under the authority of top
4.2.2 management and includes:
the facility managements
commitment to good professional
practice and quality of its service
a statement of the facilitys standard
of service
the purpose of the management
system
a requirement for all personnel to be
familiar with and implement the
quality documentation
the facility managements
commitment to compliance with the
Standard and to continually improve
the management system
these overall objectives are to be
reviewed as part of management
review.
Issued: Oct 2005
Reviewed: January 2015
COMMENTS
emphasis is on arrangements not a policy or
procedure.
facilities do need to consider this issue.
intent and applicability of this clause will be
dependent on both type of testing and size of
facility and the policies and procedures should
therefore reflect this.
examples where this clause may need to be
considered include staff who have responsibilities
in production or marketing as well as testing;
acceptance of sub-standard materials or services,
e.g. training, calibrations.
clause does require policies and procedures.
may not always be examples of 'conflict of
interest' evident.
may be linked to 4.1.5b.
need to ensure requirements of the Standard are
met in terms of facilities needs and activities.
management system requirements should be
there to support (and help improve) laboratories
activities.
if variable practices observed during an
assessment, may be that documented
procedures need improving.
quality policy is the facilitys document and should
reflect that "personality".
points need to be addressed to ensure intent has
been met rather than literally, e.g. authority of top
management.
facilities should be encouraged to consider
inclusion of reference to 17025 in next review of
their quality policy.
Page 2 of 8
CLAUSE REQUIREMENT COMMENTS
Quality manual maintain a quality manual that: The quality manual needs to be uniquely identified to
4.2.2, 4.2.5, 4.2.6 defines management system the facility. This does not however necessarily mean
policies and objectives that it must include the name, phone number and
address.
includes or makes reference to
supporting procedures, including
technical procedures and outlines
structure of the documentation in
the management system
defines the roles and
responsibilities of technical
management and the quality
manager

4.3 Document Control

Approval and ensure documents are reviewed and no requirement for amendment record per se.
issue approved by authorised personnel prior
4.3.2.1 to issue, and are included on a master
list which identifies the revision status
and distribution
Identification all management system documents must issuing authority doesn't necessarily have to be a
4.3.2.3 be uniquely identified and include date of "person", can be a "position".
issue and/or revision identification, page
numbering, total number of pages or a
mark to signify the end of the document,
and the issuing authority(ies)
Altered or new ensure where practical, the altered or new or altered text does not necessarily have to
text 4.3.3.2 new text is identified in the document or be identified.
the appropriate attachments

4.4 Review of requests, tenders and contracts

Policies and ensure policies and procedures related important that facility is capable of doing the work
procedures to review of requests, tenders and that it commits to.
4.4.1, 4.4.3 contracts are established, maintained important that facility and its customers agree on
and include: their requirements initially, i.e. at the time of
defining, documenting and contract review.
understanding customer
requirements before commencing
work
facilitys capability and resources
appropriate method selection
work that is subcontracted by the
facility
Records of maintain records of reviews, including evidence of contract review and changes to
review any significant discussions and/or contracts will vary depending on the facilitys
4.4.2 changes throughout the contract needs, e.g. it may be part of sample receipt
records, order requests or part of a larger project
contract review being undertaken by the
organisation.
4.5 Subcontracting of tests and calibrations
Competency ensure that subcontractors are
4.5.1, 4.5.4 competent (e.g. accredited facility) and
records are maintained of subcontractors a better approach than requesting a copy of the
used and their competency (e.g. scope scope of accreditation.
of accreditation)

Issued: Oct 2005 Page 3 of 8

Reviewed: January 2015
CLAUSE REQUIREMENT COMMENTS

4.6 Purchasing services and supplies

Purchasing ensure purchasing documents for facility must be able to demonstrate that it has
documents items affecting the quality of work are established and approved what it is buying
4.6.3 reviewed and approved for technical from its suppliers.
content prior to release

4.7 Service to the customer

Cooperation cooperate with customers to clarify
4.7.1 requests and monitor facility's
performance whilst ensuring
confidentiality to other customers
4.8 Complaints
Policy, procedure document policy and procedure for the
and records resolution of complaints from customers
4.8 or other parties and ensure records of
the complaints, investigations and
corrective actions (4.11) are maintained
no documented procedure required by Standard.
looking for evidence.
part of facilitys good business practice.
may be under 'contract review'.
clause is applicable to small in-house testing
facilities.
may be handled through corrective action
procedure.

4.9 Control of nonconforming testing and/or calibration work

Policies and ensure policy and procedures are documentation is required by the Standard.
procedures implemented when work or results do not may be found as part of corrective action, internal
4.9.1 conform to own procedures or customer audits and/or preventive action.
requirements and include:
examples include QC results out of spec,
defined responsibilities, authorities calibration/check on a piece of equipment that is
and actions out of spec.
an evaluation of the significance of defined responsibilities may be included in duty
the non conforming work statements/organisation charts etc.
corrective actions and decision
about the acceptability of the
nonconforming work to be taken
immediately
notification of the customer and
work recall, if necessary
defined responsibility for authorising
the resumption of work.

4.10 Improvement
4.11 Corrective action
4.12 Preventive action
Identification and ensure needed improvements and useful info provided in the 2 notes to the clause in
action 4.12 potential sources of nonconformities are the Standard.
identified and action plans developed, don't just look for a preventive action' section in
implemented and monitored, using the quality manual.
controls to ensure they are effective
look for examples, e.g. in management and
contract reviews.
not a reaction to "mistakes".

Issued: Oct 2005 Page 4 of 8

Reviewed: January 2015
CLAUSE REQUIREMENT COMMENTS

4.13 Control of records

Corrections to ensure any changes to the original does not specifically require date of change to be
records records (including electronic) are made recorded. This, however, continues to be good
4.13.2.3 so that: laboratory practice and has been included in the
original record is not obscured Standard Application Document.
correct value entered alongside
alterations signed or initialled by the
person making the correction
equivalent measures must be taken
for records stored electronically

4.14 Internal audits

Requirements internal audits shall be conducted
4.14.1 periodically and in accordance with
a predetermined schedule and
procedure to verify continuing
compliance with the requirements of
the management system and NATA
Accreditation Criteria (NAC)
quality manager is responsible for
planning and organising audits to be
carried out by trained and qualified
personnel independent of activity
being audited (where resources
permit)
training can be internal and/or experience based
providing there are records available to
demonstrate this training.
records of qualifications of auditors may be part
of staff member's training records.
person carrying out internal audits is to be
'independent' where 'resources permit', therefore
not always a requirement.
if external person used to carry out internal
audits then evidence of person's training and/or
qualifications to carry out the audits must be
available in the facility.
facility needs to ensure management system
meets requirements of the Standard, e.g. through
management review records, authorisation of
amendments to documents, etc.

4.15 Management reviews

5 TECHNICAL REQUIREMENTS
5.2 Personnel
Authorised ensure management has authorised training protocol/procedure (5.2.2) and/or job
personnel specific personnel to: descriptions (5.2.4) may provide the detail and
5.2.5 perform specific sampling, testing records for a facility to demonstrate authorisation
and/or calibration activities and competence.
issue test reports and/or calibration how specific training records need to be is
certificates and that signatory dependent on type of testing/calibration activity
approval has been taken into and how detailed the supporting documentation
consideration is.
give opinions and interpretations (in
those fields of testing where
permitted on test reports)
operate particular types of
equipment and that records for all
technical personnel (including
contracted personnel) are
maintained for:
relevant authorisation(s) including
date on which authorisation and/or
competence is confirmed
competence educational and
professional qualifications
training, skills and experience

Issued: Oct 2005 Page 5 of 8

Reviewed: January 2015
CLAUSE REQUIREMENT COMMENTS

5.3 Accommodation and environmental conditions

5.4 Test and calibration methods and method validation
Uncertainty of calibration facilities or testing facilities must be raised and discussed with facility staff as
measurement performing their own calibrations must per Standard Application Document.
5.4.6.1 have and implement procedures for
estimating the uncertainty of
measurement for all calibrations

5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
Procedures and ensure procedures for sampling are further discussions being held at field and AAC
plan available at the sampling location and level, e.g. in relation to where and when it applies
5.7.1 include: and whether or not accreditation will be available
a sampling plan (based on for the sampling plan aspect of this clause.
appropriate statistical methods,
wherever reasonable)
factors to be controlled to ensure
validity of the test/calibration results

5.8 Handling of test and calibration items

5.9 Assuring the quality of test and calibration results
5.10 Reporting the results
Test reports and results of tests and calibrations
calibration must be reported accurately,
certificates clearly, unambiguously, objectively
5.10.1, 5.10.8 and in accordance with any specific
instructions in the methods
test reports and calibration
certificates must include all
information requested by the
customer, required by the method
and necessary for the interpretation
of the test or calibration results
results may be reported in a
"simplified" reports are being considered by the
simplified way when performed for
internal customers or in the case of
Sector Managers (SM). If a facility makes such
a written agreement with customer, a request, it must be forwarded to the relevant
however, any information not SM and the General Manager, Operations and
reported to the customer, but is Technical.
normally required to be, must be
readily available in the facility
test reports and calibration
certificates must be designed to
accommodate each type of test or
calibration carried out and to
minimise the possibility of
misunderstanding or misuse
for details on the use of the NATA
endorsement refer to the Standard
Application Document (SAD) and
the NATA Rules.

Issued: Oct 2005 Page 6 of 8

Reviewed: January 2015
CLAUSE REQUIREMENT COMMENTS
Test reports test reports must include the
5.10.2, 5.10.3 information listed in the Standard
under 5.10.2 items (a) to (k) and the
SAD
a title (a)
name and address of the facility,
and the location where the
testing/calibrations were carried
out, if different from the address of
the location (b)
unique identification of the
test/calibration document,
including on each page an
identification to ensure the page is
recognised as part of the
document and a clear
identification of the end of the
document (c)
name and address of the may not be needed where facility carries out in-
customer (d) house testing - use common sense approach.
may also be met by inclusion of customer name
and code, e.g. project or job number that is
traceable within the facilitys records.

identification of the method used

(e)
description, condition and
identification of the item tested or
calibrated (f)
date of receipt of test/calibration
item where applicable and the
date the work was carried out (g)
reference to the sampling plan
and procedures used by the
facility or other bodies where
applicable (h)
results with, where appropriate,
the units of measurement (i)
name, function and signature or "function" can be approved signatory or job title.
equivalent identification of person
authorising the test/calibration
document (j)
statement to the effect that the
results relate only to the items
tested or calibrated where
applicable (k)

Issued: Oct 2005 Page 7 of 8

Reviewed: January 2015
CLAUSE REQUIREMENT COMMENTS
5.10.2, 5.10.3 where necessary for the
(continued) interpretation of the test results the
items included in 5.10.3.1 (a) to (e)
must also be included in the test
report with the exception of (d)
which is not permitted in all fields of
testing (refer to relevant field
specific Application Documents)
deviations, additions or exclusions
from the test method, and specific
test conditions, e.g. environmental
conditions (a)
statement of compliance/non-
compliance with requirements
and/or specifications (b)
statement on the estimated
uncertainty of measurement
where applicable (information on
uncertainty is needed in test
reports when it is relevant to the
validity or application of the
results, when a customers
instruction requires or when the
uncertainty affects compliance to
a specification limit) (c)
opinions and interpretations where
appropriate and needed (d) -
additional information required by
specific methods or customers (e)
test reports containing the results of
sampling must also include the
additional requirements listed in
5.10.3.2 (a) to (f) as necessary for
the interpretation of the test results
date of sampling (a)
unambiguous identification of the
material sampled (b)
location of sampling including any
diagrams, sketches or
photographs (c)
reference to the sampling plan
and procedures used (d)
details of environmental conditions
during sampling (e)
any standard or specification for
the sampling method or procedure
and deviations, additions or
exclusions from the specification
(f)
Opinions and in those fields of testing where not statements of fact and compliance are not
interpretations permitted written authority must be considered to be an opinion.
5.10.5 granted by NATAs Chief Executive
currently extensive discussion at an
international level regarding the inclusion of
opinions on test reports.

Issued: Oct 2005 Page 8 of 8

Reviewed: January 2015