LABORATORY

ASSESSMENT

WORKSHEET

This assessment worksheet has been designed to assist both the laboratory staff and
the assessment team. Laboratory staff can use this checklist as part of their
preparation for the introduction of ISO/IEC 17025 and an assessment. There is NO
need to return the completed checklist to the Association. The assessment team,
i.e. the NATA staff officer and the technical assessor can use this worksheet to assist
in the collection of all relevant information during the assessment process.

References to the relevant clauses of the NATA Accreditation Requirements (NAR)

have been provided. Both the Standard itself and the field application document
should be checked for further details, as this worksheet provides only a brief summary
of the clauses of the Standard.

The clauses, or part thereof, in bold font represent new requirements or additional
emphasis with the introduction of ISO/IEC 17025.

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002

Laboratory Assessment Worksheet.doc Page 1 of 27
Laboratory Assessment Worksheet No.

4 MANAGEMENT REQUIREMENTS

4.1 Organisation

CLAUSE REQUIREMENT COMMENTS

Scope of ensure management system covers

management activities in the laboratory’s
system permanent facility, sites away from
its permanent facilities, temporary
4.1.3 or mobile facilities

Conflict of when part of an organisation, ensure

interest the laboratory defines the
responsibilities of key personnel to
4.1.4 identify potential conflicts of
interest

Managerial and ensure managerial and technical

technical personnel have the authority and
personnel resources needed to carry out duties
and to identify and initiate actions
4.1.5a to prevent or minimise departures
from the quality system or
testing/calibration procedures

Undue pressure ensure arrangements are in place so

that management and personnel are
4.1.5b free from internal and external
commercial, financial and other
pressures that might adversely
affect the quality of their work

Client ensure there are policies and

confidentiality procedures related to client
confidentiality, including electronic
4.1.5c storage and transmission of results

Operational ensure the laboratory has policies

integrity and procedures to avoid
involvement in activities that
4.1.5d compromise the confidence in its
competence, impartiality,
judgement or operational integrity

Organisation the organisation and management

chart structure needs to be defined,
including relationships between
4.1.5e quality management, technical
operations, support services and
parent organisation (if applicable)

Responsibility specify the responsibility and

and authority authority of all personnel who
manage, perform or verify work
4.1.5f affecting the quality of the tests
and/or calibrations
17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 2 of 27
Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Laboratory ensure adequate supervision by

supervision appropriate personnel of all staff
involved in calibration and testing
4.1.5g activities

Technical identify technical management that

management has overall responsibility for
technical operations and resources
4.1.5h

Quality appoint a member of staff, with

manager direct access to senior
management, as quality manager
4.1.5i who has defined responsibility and
authority for implementing and
maintaining the quality system

Managerial where practical, appoint deputies for

deputies key managerial personnel
4.1.5j

4.2 Quality System

Policies and document policies and procedures

procedures as a quality system to ensure quality
of all work and that they are
4.2.1 communicated, available,
understood and implemented

Quality policy ensure the quality policy

statement statement is issued under the
authority of the chief executive
4.2.2 and includes:
the laboratory management’s
commitment to good
professional practice and
quality of its service
a statement of the laboratory’s
standard of service
the objectives of the quality
system
a requirement for all personnel
to be familiar with and
implement the quality
documentation
the laboratory management’s
commitment to compliance
with the Standard

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 3 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Quality manual maintain a quality manual that:

4.2.2, 4.2.3, defines quality system policies
and objectives
4.2.4
includes or makes reference to
supporting procedures, including
technical procedures and outlines
structure of the documentation in
the quality system
defines the roles and
responsibilities of technical
management and the quality
manager

4.3 Document Control

Procedures ensure procedures to control all

documentation included in the
4.3.1 quality system are established and
maintained

Approval and ensure documents are reviewed and

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

Availability ensure all necessary quality

documentation is available where
4.3.2.2 required, reviewed and revised to
maintain suitability

Obsolete ensure documents are removed

documents when obsolete and suitably
marked if retained for either legal
4.3.2.2 or knowledge preservation
purposes

Identification all quality system documents

must be uniquely identified and
4.3.2.3 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)

Document ensure changes to documents are

changes reviewed and approved by the
same function that performed the
4.3.3.1 original review, or a designate

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 4 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Altered or new ensure where practical, the

text altered or new text is identified in
the document or the appropriate
4.3.3.2 attachments

Handwritten ensure if hand written

amendments amendments are allowed, defined
procedures are available, which
4.3.3.3 include authorities, clear marking,
initialling, dating, and formal re-
issue

Electronic establish procedures to describe

documents how changes in documents
maintained electronically are
4.3.3.4 made and controlled

4.4 Review of requests, tenders and contracts

Policies and ensure policies and procedures

procedures related to review of requests,
tenders and contracts are
4.4.1, 4.4.3 established, maintained and
include:
defining, documenting and
understanding client
requirements before
commencing work
laboratory’s capability and
resources
appropriate method selection
work that is subcontracted by
the laboratory

Records of maintain records of reviews,

review including any significant
discussions and/or changes
4.4.2 throughout the contract

Notification of ensure client is informed of any

client deviation from the contract
4.4.4

Changes to ensure same contract review

contracts process is repeated if a contract
has to be amended after work has
4.4.5 commenced and that all affected
staff are advised of the
amendment

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 5 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

4.5 Subcontracting of tests and calibrations

Competency ensure that subcontractors are

competent (eg accredited
4.5.1, 4.5.4 laboratory) and records are
maintained of subcontractors used
and their competency (eg scope of
accreditation)

Client approval ensure client is advised in writing

and approval gained where
4.5.2 appropriate

Responsibility unless client or regulatory

authority specifies subcontractor,
4.5.3 laboratory is responsible for
subcontractors’ work

4.6 Purchasing services and supplies

Policies and document policies and procedures

procedures for selection, purchasing, reception
and storage of relevant services and
4.6.1 supplies

Verification ensure all purchased supplies that

affect the quality are not used until
4.6.2 verified as complying with defined
specifications, and records of the
actions taken to demonstrate
compliance are maintained

Purchasing ensure purchasing documents for

documents items affecting the quality of work
are reviewed and approved for
4.6.3 technical content prior to release

Approved maintain a list and records of the

suppliers evaluations of all approved
suppliers
4.6.4

4.7 Service to client

Cooperation afford clients cooperation to

clarify requests and monitor
4.7 laboratory's performance whilst
ensuring confidentiality to other
clients

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 6 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

4.8 Complaints

Policy, document policy and procedure for

procedure and the resolution of complaints from
records clients or other parties and ensure
records of the complaints,
4.8 investigations and corrective actions
(4.10) are maintained

4.9 Control of nonconforming testing and/or calibration work

Policies and ensure policy and procedures are

procedures implemented when work or
results do not conform to own
4.9.1 procedures or client requirements
and include:
defined responsibilities,
authorities and actions
an evaluation of the
significance of the non-
conforming work
corrective actions and decision
about the acceptability of the
nonconforming work to be
taken immediately
notification of the client and
work recall, if necessary
defined responsibility for
authorising the resumption of
work

Recurrence corrective action procedures

(4.10) must be implemented when
4.9.2 evaluation indicates recurrence
could occur or there is doubt
regarding compliance of
laboratory's operations with own
policies and procedures

4.10 Corrective action

Policies and establish policy and procedures,

procedures and designate appropriate
authorities for implementing
4.10 corrective actions which include:
cause analysis to determine
the root cause (4.10.2)

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 7 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

4.10 (cont.) selection, implementation and

documentation of corrective
actions (4.10.3)
monitoring results to ensure
effectiveness of corrective
actions (4.10.4)
areas affected are to be
audited (4.13) if
nonconformance indicates
laboratory not complying with
own quality system (4.10.5)

4.11 Preventive action

Identification ensure needed improvements and

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

4.12 Control of records

CLAUSE REQUIREMENT COMMENTS

Procedures establish and maintain procedures

covering aspects listed below for
4.12.1.1 control of quality and technical
records:
identification
collection
indexing
access
filing
storage
maintenance
disposal
protect, back-up and prevent
unauthorised access to or
amendment of records stored
electronically (4.12.1.4)

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 8 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Record integrity ensure all records are:

4.12.1.2 legible
readily retrievable
maintained in a suitable
environment
retained for established time
held secure and in confidence
(4.12.1.3)

Technical ensure laboratory retains technical

records records of:
4.12.2.1 original observations
derived data
sufficient information to establish
an audit trail
calibration records
staff records
copy of each test report or
calibration certificate issued
identity of personnel responsible
for the sampling
identity of personnel responsible
for test/calibration
identity of personnel responsible
for checking results
and that retained records of each
test or calibration contain sufficient
information to:
identify factors affecting the
uncertainty
enable the test or calibration to
be repeated using original
conditions

Recording ensure observations, data and

calculations are recorded at the time
4.12.2.2 they are made and are identifiable to
the specific task

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 9 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Corrections to ensure any changes to the original

records records (including electronic) are
made so that:
4.12.2.3
original record is not obscured
correct value entered alongside
alterations signed or initialled by
the person making the correction
equivalent measures must be
taken for records stored
electronically

4.13 Internal audits

Requirements internal audits shall be conducted

periodically and in accordance
4.13.1 with a predetermined schedule
and procedure to verify
continuing compliance with the
requirements of the quality
system and NAR
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)

Corrective where validity of results has been

action and questioned, timely corrective action
notification of must be taken and clients notified in
clients writing if it is shown that laboratory
results have been affected
4.13.2

Records records of area audited, audit

findings and corrective actions must
4.13.3 be retained

Follow-up follow-up audits shall verify and

audits record implementation and
effectiveness of corrective action
4.13.4

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 10 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

4.14 Management reviews

Objectives ensure the laboratory’s

management conducts a review
4.14.1 yearly of the quality system and
testing/calibration activities, based
on a predetermined schedule and
procedure to ensure continuing
suitability and effectiveness and to
introduce necessary changes or
improvements

Contents ensure the review includes:

4.14.1 suitability of policies and
procedures
reports from managerial and
supervisory personnel
outcome of recent internal
audits
corrective and preventive
actions
assessments by external
bodies
results of interlaboratory
comparisons or proficiency
tests
changes in the volume and
type of the work
client feedback
complaints
other relevant factors (eg
quality control activities,
resources and staff training)

Actions and ensure findings and actions are

records recorded and carried out within an
appropriate and agreed timescale
4.14.2

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 11 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

5 TECHNICAL REQUIREMENTS

5.2 Personnel

CLAUSE REQUIREMENT COMMENTS

Competence ensure personnel performing

specific tasks are qualified on the
5.2.1 basis of education, training,
experience and/or demonstrated
skills and that when staff are being
trained appropriate supervision is
provided

Training policy policy and procedures must be

implemented for identifying
5.2.2 training needs and providing
training

Employees ensure personnel are employed

or contracted by the laboratory,
5.2.3 and ensure contracted personnel
are supervised, competent and
work in accordance with the
quality system

Job maintain current job descriptions for

descriptions managerial, technical and key
support staff
5.2.4

Authorised ensure management has

personnel authorised specific personnel to:
5.2.5 perform specific sampling, testing
and/or calibration activities
issue test reports and/or
calibration certificates and that
NATA signatory approval has
been taken into consideration
give opinions and interpretations
(these are only permitted on
endorsed test reports in the fields
of Medical, Veterinary and
Forensic testing)
operate particular types of
equipment

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 12 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

5.2.5 (cont.) 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

5.3 Accommodation and environmental conditions

Facility ensure the laboratory or off-site

facility(ies) and environmental
5.3.1 conditions do not compromise the
quality of results and that the
technical requirements for critical
accommodation and environmental
conditions are documented

Monitoring ensure the laboratory monitors,

controls and records environmental
5.3.2 conditions, where applicable and
that tests and/or calibrations are
stopped when results are
jeopardised by the environmental
conditions

Incompatible ensure there is effective separation

activities between areas of incompatible
activity
5.3.3

Access ensure access to office and

laboratory areas is controlled
5.3.4

Housekeeping ensure housekeeping measures are

adequate
5.3.5

5.4 Test and calibration methods and method validation

Methods and ensure laboratory uses appropriate

procedures methods and procedures for all
calibration and test activities
5.4.1 covered by scope of accreditation
and that all instructions, standards,
manuals, and reference data are
current and available to personnel
17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 13 of 27
Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Method ensure that deviations from the test

deviations and calibration methods are:
5.4.1 documented
technically justified
authorised
accepted by client

Method ensure laboratory selects and uses

selection test and/or calibration methods that:
5.4.2 meet the needs of the client; and
are appropriate for the test and/or
calibration
the client has been informed of
the method chosen (if not
specified)
where appropriate, are based on
latest international, regional or
national standards and where
necessary the standard be
supplemented with additional
details to ensure consistent
approach
have been verified for use in
the laboratory, if a standard
method

Inappropriate ensure laboratory informs the

methods client if the method proposed by
the client is inappropriate or out
5.4.2 of date

Laboratory- ensure introduction of these

developed and methods is planned, and
non-standard assigned to qualified personnel
methods with adequate resources and that
plans are updated as
5.4.3, 5.4.4 development proceeds and
communicated as necessary
when methods are used that are
not covered by standard
methods, then:
- purpose of the test and/or
calibration must be identified
- method developed must be
validated before use
- client agreement must be
obtained and include
specification of client
requirements
17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 14 of 27
Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Method laboratory must validate:

validation - non-standard methods
5.4.5.2 - laboratory-
designed/developed methods
- standard methods used
outside their intended scope
- amplifications and
modifications of standard
methods
records for method validation
must include
- results obtained
- procedure used
- statement as to whether the
method is fit for the
intended use

Range and ensure the range and accuracy of

accuracy the values obtainable from
validated methods are relevant to
5.4.5.3 the clients’ needs

Uncertainty of calibration laboratories or testing

measurement laboratories performing their own
calibrations must have and
5.4.6.1 implement procedures for estimating
the uncertainty of measurement for
all calibrations

5.4.6.2 testing laboratories must

document and implement
procedures for estimating
uncertainty of measurement (refer
to FAD for application of this
clause)

5.4.6.3 all uncertainty components which

are of importance in the given
situation must be taken into
account using appropriate
methods of analysis when
estimating the uncertainty of
measurement

Calculations ensure calculations and data

and data transfers are checked in a
transfers systematic manner
5.4.7.1

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 15 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Computers and ensure when computers or

automated automated equipment are used for
equipment acquisition, processing, recording,
reporting, storage or retrieval of
5.4.7 test/calibration data that:
laboratory developed software is
sufficiently documented and
suitably validated
procedures are established and
implemented for protecting the
data and include
- integrity and confidentiality of
data entry or collection
- data storage
- data transmission
- data processing
computers and automated
equipment are maintained to
ensure proper functioning
appropriate environmental and
operating conditions are provided

5.5 Equipment

Operation ensure all equipment and its

software (including that outside the
5.5.1 to 5.5.4 laboratory’s permanent control)
required for all testing and/or
calibration activities:
is available and functioning
properly (5.5.1)
is capable of achieving required
accuracy (5.5.2)
complies with relevant
specifications (5.5.2)
has calibration programs
established for key quantities or
values (5.5.2)
is calibrated or checked before
being placed into service (5.5.2)
is checked and/or calibrated
before use (see 5.6 also) (5.5.2)
is operated by authorised
personnel (5.5.3)
has current instructions on use
and maintenance available
(5.5.3)
is uniquely identified, where
practicable (5.5.4)
17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 16 of 27
Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Records ensure records of equipment and its

software are maintained and
5.5.5 include:
identity of the equipment and its
software
manufacturer’s name, model, and
serial number or other unique
identification
evidence that the equipment
complies with the accuracy
requirements and with
specifications relevant to the
tests or calibrations
current location, where
appropriate
the manufacturer’s instructions, if
available, or reference to their
location
calibration history and due date
of next calibration
the maintenance plan, where
appropriate, and maintenance
carried out to date
any damage, malfunction,
modification or repair to the
equipment
Procedures ensure procedures for measuring
equipment are documented and
5.5.6, 5.5.11 include:
safe handling
transport
storage
use
planned maintenance
where applicable, that copies
of correction factors are
correctly updated

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 17 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Out-of-service ensure equipment subjected to

overloading or mishandling, giving
5.5.7 suspect results, or shown to be
defective or outside specified limits
is taken out of service, and is:
isolated or clearly labelled or
marked as being out of service
examined for the effect of the
defect or departure from specified
limits on previous tests and/or
calibrations
addressed under the “Control of
nonconforming work” procedure
(4.9)
Calibration ensure equipment calibration status
status is identified, where practicable and
where intermediate checks are
5.5.8, 5.5.10 needed to maintain confidence in
the calibration status that a
procedure is documented to carry
out these checks

Return to ensure when equipment goes

service outside the direct control of the
laboratory, that the function and
5.5.9 calibration status are checked
before being returned to service

Adjustments ensure equipment, both hardware

and software, is safeguarded
5.5.12 from adjustments which could
invalidate the test/calibration
results

5.6 Measurement traceability

Calibration ensure all equipment used in testing

program and/or calibration activities is
calibrated using a defined procedure
5.6.1 before being put into service and is
included in the equipment calibration
program

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 18 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Calibration must ensure the program for

laboratories calibration of equipment is designed
and operated so that calibrations
5.6.2.1 and measurements are traceable to
SI units, however, where traceability
cannot be strictly made to SI units,
traceability can be established by
use of:
certified reference materials
specified methods and/or
consensus standards that are
clearly described and agreed by
all parties concerned
Participation in suitable
interlaboratory comparisons is
required where possible.

Testing the requirements given in 5.6.2.1

laboratories apply for measuring and test
equipment unless it can be
5.6.2.2 established that the associated
contribution from the calibration
contributes little to the total
uncertainty of the test result

Reference program and procedure for

standards calibration of reference standards
must be implemented
5.6.3.1
reference standards must include
traceability as described in
5.6.2.1
reference standards of
measurement must be used for
calibration only
reference standards must be
calibrated before and after
adjustment
Reference where possible, reference
materials materials must be traceable to SI
units or certified reference
5.6.3.2 materials
internal reference materials must
be checked

Intermediate procedures and schedules must be

checks available to carry out intermediate
checks on reference, primary,
5.6.3.3 transfer or working standards and
reference materials to maintain
confidence in the calibration status

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 19 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Transport and procedures for safe handling,

storage transport, storage and use of
reference standards and materials
5.6.3.4 must be available

5.7 Sampling

Procedures and ensure procedures for sampling

plan are available at the sampling
location and include:
5.7.1
a sampling plan (based on
appropriate statistical
methods, wherever
reasonable)
factors to be controlled to
ensure validity of the
test/calibration results

Deviations ensure client-requested

deviations, additions or
5.7.2 exclusions from the documented
sampling procedures are
recorded and communicated to
the appropriate personnel

Records ensure laboratory has procedures

for recording sampling data and
5.7.3 operations and that the records
include:
sampling procedure used
identification of the sampler
environmental conditions (if
relevant)
diagrams (or equivalent) to
identify sampling location
statistics that sampling
procedure is based on, if
appropriate

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 20 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

5.8 Handling of test and calibration items

Procedures document procedures for test and/or

calibration item management which
5.8.1 ensure protection of integrity of the
item and the interests of the
laboratory and client and cover:
transportation
receipt
handling
protection
storage
retention and/or disposal

Identification ensure laboratory has a system for

identifying test and/or calibration
5.8.2 items both physically and in the
records and accommodate
subdivision of groups of items, if
applicable

Deficiencies ensure any abnormalities or

deficiencies on item received are
5.8.3 recorded
if there is doubt about suitability
of item, or it does not conform to
description provided, or the test
or calibration required is not
specified, ensure that the client is
contacted and that the
instructions are recorded

Facilities ensure laboratory has procedures

and appropriate facilities to maintain
5.8.4 item integrity, and the protection of
secured items and when specified
environmental conditions are
required, that these are maintained,
monitored and recorded

5.9 Assuring the quality of test and calibration results

Quality Control ensure laboratory has quality

control procedures for monitoring
5.9 validity of tests and calibrations; it
must be a planned activity that is
reviewed and includes:

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 21 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

5.9 (cont.) - regular use of certified

reference materials and/or
secondary reference
materials
- participation in
interlaboratory comparison
or proficiency-testing
programs
- replicates using the same or
different methods
- retesting or recalibration of
retained items
- correlation of results for
different characteristics of
an item
resulting data must be recorded
so as trends are detectable and
statistical techniques must be
applied to the reviewing of the
results where practicable

5.10 Reporting the results

CLAUSE REQUIREMENT COMMENTS

Test reports results of tests and calibrations

and calibration must be reported accurately,
certificates clearly, unambiguously,
objectively and in accordance
5.10.1, 5.10.8 with any specific instructions in
the methods
test reports and calibration
certificates must include all
information requested by the
client, 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 clients or in the case
of a written agreement with client,
however, any information not
reported to the client, but is
normally required to be, must be
readily available in the laboratory

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 22 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

5.10.1, 5.10.8 test reports and calibration

(cont.) 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
Field Application Document and
the NATA Rules

Test reports test reports must include the

information listed in the Standard
5.10.2, 5.10.3
under 5.10.2 items (a) to (k) and
the FAD

- a title (a)

- name and address of the

laboratory, 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

client (d)

- 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 laboratory or other bodies
where applicable (h)

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 23 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

5.10.2, 5.10.3 - results with, where

(cont.) appropriate, the units of
measurement (i)

- name, function and signature

or 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)

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 allowable
under NATA’s bylaws except
for Medical, Veterinary and
Forensic testing (Note: (c) is
new)

- 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 client’s
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 clients (e)

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 24 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

5.10.2, 5.10.3 test reports containing the results

(cont.) 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)

Calibration calibration certificates must

certificates include the information listed in
the Standard under 5.10.2 items
5.10.2, 5.10.4
(a) to (k)

where necessary for the

interpretation of the calibration
results, the requirements
included in 5.10.4.1 (a) to (c)
must also be included in the
calibration certificate

- conditions, e.g. environmental

during calibration that have an
influence on the
measurement results (a)

- uncertainty of measurement
and/or statement of
compliance with an identified
metrological specification(b)

- evidence that the

measurements are traceable
(c)

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 25 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

5.10.2, 5.10.4 if a statement of compliance

(cont.) with a specification is made,
the clauses of the specification
which are met or not met must
be identified (5.10.4.2)

where a statement of
compliance is made omitting
the measurement results and
associated uncertainties, the
laboratory must record and
retain those results (5.10.4.2)

the uncertainty of
measurement must be taken
into account when statements
of compliance are made
(5.10.4.2)

calibration results before and

after adjustment or repair, if
available, must be reported
(5.10.4.3)

calibration certificates or
labels must not contain any
recommendation on the
calibration interval except
when requested by the client
(5.10.4.4)

Opinions and Are not permitted on endorsed

interpretations test reports unless written
authority has been granted by
5.10.5 NATA’s Chief Executive except
for Medical, Veterinary and
Forensic testing

Testing and results of tests performed by

calibration subcontractors must be clearly
results obtained identified
from
subcontractors where calibration work has been
subcontracted, the laboratory
5.10.6
performing the work must issue
the calibration certificate to the
contracting laboratory

Electronic where results are transmitted

transmission of electronically or electromagnetically
results the requirements set out in the
Standard must be met
5.10.7

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 26 of 27

Laboratory Assessment Worksheet.doc
Laboratory Assessment Worksheet No.

CLAUSE REQUIREMENT COMMENTS

Amendments to amendments to a test report or

test reports and calibration certificate after issue
calibration must be in the form of a further
certificates document or data transfer and
include reference to the original
5.10.9
as detailed in the Standard and
meet the requirements of NAR

when a complete new test report

or calibration certificate is
required, it must be uniquely
identified and include a reference
to the original it replaces

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 3/December 2002 Page 27 of 27

Laboratory Assessment Worksheet.doc