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:
Reviewed:

Oct 2005
January 2015

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MANAGEMENT REQUIREMENTS

4.1

Organisation

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REQUIREMENT

COMMENTS

Undue pressure
4.1.5b

ensure arrangements are in place so that

management and personnel are free
from internal and external commercial,
financial and other pressures that might
adversely affect the quality of their work

emphasis is on arrangements not a policy or

procedure.

Operational
integrity
4.1.5d

ensure the facility has policies and

procedures to avoid involvement in
activities that compromise the
confidence in its competence,
impartiality, judgement or operational
integrity

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.

4.2 Management System

Policies and
procedures
4.2.1

document policies and procedures as a

management system to ensure quality of
all work and that they are communicated,
available, understood and implemented

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
statement
4.2.2

ensure the quality policy statement is

issued under the authority of top
management and includes:
the facility managements
commitment to good professional
practice and quality of its service
a statement of the facilitys standard
of service

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.

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:
Reviewed:

Oct 2005
January 2015

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CLAUSE

REQUIREMENT

COMMENTS

Quality manual
4.2.2, 4.2.5, 4.2.6

maintain a quality manual that:

The quality manual needs to be uniquely identified to

the facility. This does not however necessarily mean
that it must include the name, phone number and
address.

defines management system

policies and objectives
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
issue
4.3.2.1

ensure documents are reviewed and

approved by authorised personnel prior
to issue, and are included on a master
list which identifies the revision status
and distribution

no requirement for amendment record per se.

Identification
4.3.2.3

all management system documents must

be uniquely identified and include date of
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)

issuing authority doesn't necessarily have to be a

"person", can be a "position".

Altered or new
text 4.3.3.2

ensure where practical, the altered or

new text is identified in the document or
the appropriate attachments

new or altered text does not necessarily have to

be identified.

4.4
Review of requests, tenders and contracts
Policies and
ensure policies and procedures related
procedures
to review of requests, tenders and
4.4.1, 4.4.3
contracts are established, maintained
and include:
defining, documenting and
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
review
any significant discussions and/or
4.4.2
changes throughout the contract

4.5

important that facility is capable of doing the work

that it commits to.
important that facility and its customers agree on
their requirements initially, i.e. at the time of
contract review.

evidence of contract review and changes to

contracts will vary depending on the facilitys
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.

Subcontracting of tests and calibrations

Competency
4.5.1, 4.5.4

Issued:
Reviewed:

ensure that subcontractors are

competent (e.g. accredited facility) and
records are maintained of subcontractors
used and their competency (e.g. scope
of accreditation)

Oct 2005
January 2015

a better approach than requesting a copy of the

scope of accreditation.

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CLAUSE

4.6

REQUIREMENT

COMMENTS

Purchasing services and supplies

Purchasing
documents
4.6.3

ensure purchasing documents for

items affecting the quality of work are
reviewed and approved for technical
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

facility must be able to demonstrate that it has

established and approved what it is buying
from its suppliers.

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.

4.8 Complaints
Policy, procedure
and records
4.8

document policy and procedure for the

resolution of complaints from customers
or other parties and ensure records of
the complaints, investigations and
corrective actions (4.11) are maintained

may be handled through corrective action

procedure.

4.9 Control of nonconforming testing and/or calibration work

Policies and
procedures
4.9.1

ensure policy and procedures are

implemented when work or results do not
conform to own procedures or customer
requirements and include:

documentation is required by the Standard.

may be found as part of corrective action, internal
audits and/or preventive action.

defined responsibilities, authorities

and actions

examples include QC results out of spec,

calibration/check on a piece of equipment that is
out of spec.

an evaluation of the significance of

the non conforming work

defined responsibilities may be included in duty

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
action 4.12

ensure needed improvements and

potential sources of nonconformities are
identified and action plans developed,
implemented and monitored, using
controls to ensure they are effective

useful info provided in the 2 notes to the clause in

the Standard.
don't just look for a preventive action' section in
the quality manual.
look for examples, e.g. in management and
contract reviews.
not a reaction to "mistakes".

Issued:
Reviewed:

Oct 2005
January 2015

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REQUIREMENT

COMMENTS

4.13 Control of records

Corrections to
records
4.13.2.3

ensure any changes to the original

records (including electronic) are made
so that:
original record is not obscured
correct value entered alongside

does not specifically require date of change to be

recorded. This, however, continues to be good
laboratory practice and has been included in the
Standard Application Document.

alterations signed or initialled by the

person making the correction
equivalent measures must be taken
for records stored electronically

4.14 Internal audits

Requirements
4.14.1

internal audits shall be conducted

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

TECHNICAL REQUIREMENTS

5.2

Personnel

Authorised
personnel
5.2.5

ensure management has authorised

specific personnel to:
perform specific sampling, testing
and/or calibration activities

training protocol/procedure (5.2.2) and/or job

descriptions (5.2.4) may provide the detail and
records for a facility to demonstrate authorisation
and competence.

issue test reports and/or calibration

certificates and that signatory
approval has been taken into
consideration

how specific training records need to be is

dependent on type of testing/calibration activity
and how detailed the supporting documentation
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:
Reviewed:

Oct 2005
January 2015

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CLAUSE

REQUIREMENT

5.3

Accommodation and environmental conditions

5.4

Test and calibration methods and method validation

Uncertainty of
measurement
5.4.6.1

calibration facilities or testing facilities

performing their own calibrations must
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
plan
5.7.1

ensure procedures for sampling are

available at the sampling location and
include:
a sampling plan (based on
appropriate statistical methods,
wherever reasonable)

COMMENTS

must be raised and discussed with facility staff as

per Standard Application Document.

further discussions being held at field and AAC

level, e.g. in relation to where and when it applies
and whether or not accreditation will be available
for the sampling plan aspect of this clause.

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 way when performed for
internal customers or in the case of
a written agreement with customer,
however, any information not
reported to the customer, but is
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:
Reviewed:

Oct 2005
January 2015

"simplified" reports are being considered by the

Sector Managers (SM). If a facility makes such
a request, it must be forwarded to the relevant
SM and the General Manager, Operations and
Technical.

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Test reports
5.10.2, 5.10.3

REQUIREMENT

COMMENTS

test reports must include the

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
customer (d)

may not be needed where facility carries out inhouse 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
equivalent identification of person
authorising the test/calibration
document (j)

"function" can be approved signatory or job title.

statement to the effect that the

results relate only to the items
tested or calibrated where
applicable (k)

Issued:
Reviewed:

Oct 2005
January 2015

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CLAUSE
5.10.2, 5.10.3
(continued)

REQUIREMENT

COMMENTS

where necessary for the

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/noncompliance 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
interpretations
5.10.5

Issued:
Reviewed:

in those fields of testing where not

permitted written authority must be
granted by NATAs Chief Executive

Oct 2005
January 2015

statements of fact and compliance are not

considered to be an opinion.
currently extensive discussion at an
international level regarding the inclusion of
opinions on test reports.

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