OD/018/V3

June 2007

INTERNATIONAL ELECTROTECHNICAL COMMISSION SCHEME FOR

CERTIFICATION TO STANDARDS FOR EXPLOSIVE ATMOSPHERES
(IECEx SCHEME)

Title: REPORT ON ISO/IEC 17025

IECEx Operational Document

This version 3 of Operational Document OD 0018, which replaces version 2,

was issued to update the document to the 2005 edition of ISO/IEC 17025

Document History

Date Summary
2004 12 Original Issue (Version 1)
2005 12 Version 2 – issued to include Annex A containing “Common
understanding of ISO/IEC 17025”
2007 06 Version 3

Address: Tel: +61 2 8206 6940

IECEx Secretariat Fax: +61 2 8206 6272
286 Sussex Street Email: chris.agius@iecex.com
Sydney NSW 2000
Australia

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REPORT ON ISO/IEC 17025

Clause Title/requirement Comments/Laboratory Assessment Notes Complies

No ?
1 Scope No requirements N/A
2 Normative references No requirements N/A
3 Terms and conditions No requirements N/A
4 Management requirements No requirements
4.1 Organization No requirements
4.1.1 Entity that can be held legally
responsible
4.1.2 Carry out activities in way to meet
this standard
4.1.3 Management system covers
permanent facilities, sites away, or
temporary or mobile facilities
4.1.4 If part of larger organization,
responsibilities defined to identify
potential conflicts of interest.
4.1.5 Laboratory shall No requirements
a) Have authority and resources

b) Have management and personnel

free from undue internal and
external commercial, financial and
other pressures
c) Have policies and procedures to
ensure confidentiality
d) Have policies and procedures to
avoid activities that would diminish
confidence in competence,
impartiality, judgement or
operational integrity
e) Define organisation and
management structure, place in
organization, and relationships
quality management, technical
operations and support services
f) Specify responsibility, authority
and interrelationships
g) Provide adequate supervision

h) Have technical management with

overall responsibility and
resources
i) Appoint member of staff as quality
manager
j) Appoint deputies for key
managerial personnel

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k) Ensure personnel aware of
relevance and importance or
their activities and how they
contribute to achievement of
objectives of quality
management system
4.2 Management system No requirements
4.2.1 Management system established.
Documentation communicated,
understood, available to and
implemented
4.2.2 Management system policies and
objectives defined in quality
manual.
Overall objectives established
and review by management
review
4.2.3 Evidence of top management
commitment
4.2.4 Top management communicate
importance of meeting
customer, statutory and
regulatory requirements
4.2.5 Quality manual – reference to
supporting procedures
4.2.6 Roles of technical management
and quality manager defined
4.2.7 Top management ensure
integrity of management system
maintained when changed
4.3 Document control No requirements
4.3.1 General
Procedures to control all
documents
4.3.2 Document approval and issue No requirements
4.3.2.1 Documents issued reviewed and
approved
4.3.2.2 Procedure to No requirements
a) Authorized edition available

b) Periodically reviewed

c) Invalid, obsolete removed

d) Obsolete retained

4.3.2.3 Management system documents

uniquely identified
4.3.3 Document changes No requirements
4.3.3.1 Changes reviewed and approved

4.3.3.2 Where practicable altered or new

text identified
4.3.3.3 If required provision for alteration
by hand

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4.3.3.4 Procedures for documents
maintained in computerized
systems
4.4 Review of requests, tenders and No requirements
contracts
4.4.1 Procedures for review of requests,
tenders and contracts
4.4.2 Records of reviews maintained

4.4.3 Cover subcontracted work

4.4.4 Customer informed of deviation

4.4.5 Same review process is contract

amended
4.5 Subcontracting of tests and No requirements
calibrations
4.5.1 Subcontract work with competent
subcontractor
4.5.2 Advice to and approval of client

4.5.3 Laboratory responsible unless

subcontractor specified by
customer or regulatory authority
4.5.4 Maintain register of all
subcontractors
4.6 Purchasing services and No requirements
supplies
4.6.1 Polices and procedures for
selection and purchasing of
services and supplies
4.6.2 Supplies, reagents and
consumable materials that affect
quality of tests not used until
inspected and verified.
Records kept
4.6.3 Purchasing documents describe
services and supplies ordered.
Documents reviewed and
approved prior to release.
4.6.4 Suppliers of critical consumables,
supplies and services evaluated.
4.7 Service to the customer No requirements

4.7.1 Cooperate with customers to

clarify request or monitor
laboratory’s performance
4.8 Complaints
Policy and procedure for
resolution of complaints
4.9 Control of nonconforming No requirements
testing and/or calibration work
4.9.1 Policy and procedures to be
implemented if work does not
conform to own procedures

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4.9.2 Corrective action followed

4.10 Improvement No requirements

Continually improve
effectiveness of management
system
4.11 Corrective action No requirements
4.11.1 Policy and procedure for
corrective action
4.11.2 Cause and analysis
Procedure for investigation to
determine root course
4.11.3 Selection and implementation of
corrective action
Where needed identify potential
corrective actions.
Document and implement required
changes
4.11.4 Monitoring of corrective actions
Monitor corrective actions have
been effective
4.11.5 Additional audits
Where nonconformances or
departures casts doubts, ensure
these areas audited
4.12 Preventive action No requirements
4.12.1 Needed improvements identified.
If preventive action required, plans
developed, implemented and
monitored.
4.12.2 Procedures include initiation of
actions and controls
4.13 Control of records No requirements
4.13.1 General No requirements
4.13.1.1 Procedures for records.
Reports from internal audits and
management reviews
4.13.1.2 Records legible, stored in suitable
environment, readily retrievable.
Retention time established.
4.13.1.3 Secure and in confidence

4.13.1.4 Procedure to protect and back-up

records stored electronically
4.13.2 Technical records No requirements
4.13.2.1 Retain records of original
observations etc.
If possible identify factors affecting
uncertainty and to enable to be
repeated.
Include identity of personnel
responsible for doing and
checking

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4.13.2.2 Observations, data and
calculations recorded at time
made
4.13.2.3 Mistakes not erased.
Alterations signed and initialled
4.14 Internal audits No requirements
4.14.1 Periodically conduct internal audits

4.14.2 If audits cast doubt, timely

corrective action and notify clients
if results may have been affected
4.14.3 Audit recorded

4.14.4 Follow-up activities verify and

record implementation and
effectiveness
4.15 Management reviews No requirements
4.15.1 Periodic review by top
management of management
system
4.15.2 Findings and actions recorded.

5 Technical requirements No requirements

5.1 General No requirements
5.1.1 Information on factors that affect No requirements
correctness and reliability of tests
5.1.2 Take account of extent factors
contribute to uncertainty of
measurement
5.2 Personnel No requirements
5.2.1 Ensure competence of personnel

5.2.2 Formulate goals with respect to

education, training and skills
5.2.3 Personnel employed or under
contract.
Ensure personnel supervised and
competent
5.2.4 Current job descriptions

5.2.5 Specific personnel authorized.

Records of authorizations,
competence, educational and
professional qualifications
5.3 Accommodation and No requirements
environmental conditions
5.3.1 Facilities such as to facilitate
correct performance of tests
5.3.2 Monitor and control conditions

5.3.3 Separation of incompatible

activities
5.3.4 Access controlled where needed

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5.3.5 Good housekeeping

5.4 Test and calibration methods No requirements

and method validation
5.4.1 General
Methods and procedures for all
tests within scope, including
sampling, handling, storage and
preparation
Instructions on use of relevant
equipment and handling items for
testing.
All instructions etc up to date and
available.
5.4.2 Selection of methods
Methods which meet need of
client.
Latest edition of standard used.
5.4.3 Laboratory-developed methods
Planned activity assigned to
qualified personnel
Plans updated as development
proceeds.
5.4.4 Non-standard methods
Subject to agreement with client.
Method developed validated
before use.
5.4.5 Validation of methods No requirements
5.4.5.1 Validation by examination and
provision of objective evidence
5.4.5.2 Non-standard, laboratory-
designed/developed, standard but
outside scope methods validated.
5.4.5.3 Range and accuracy relevant to
clients’ needs
5.4.6 Estimation of uncertainty of No requirements
measurement
5.4.6.1 Procedure to estimate uncertainty
of measurement for all calibrations
5.4.6.2 Procedure to estimate uncertainty
of measurement for testing (at
least reasonable estimation)
5.4.6.3 All uncertainty components taken
into account.
5.4.7 Control of data No requirements
5.4.7.1 Calculations and data transfers
subject to checks
5.4.7.2 When computers and automated No requirements
equipment used:
a) Computer software developed by
user documented and validated
b) Procedures for protecting data.

c) Computers and automated

equipment maintained.

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5.5 Equipment No requirements
5.5.1 Furnished with all items of
equipment required for correct
performance.
5.5.2 Equipment and software comply
with specifications
5.5.3 Equipment operated by authorized
personnel.
Up-to-date instructions on use
provided
5.5.4 Each item of equipment and
software uniquely identified.
5.5.5 Records maintained on each item
of equipment, including
identification, maintenance and
calibration.
5.5.6 Procedures for safe handling,
transport, storage, use and
planned maintenance of
measuring equipment.
5.5.7 Defective equipment taken out of
service
5.5.8 Identified to show calibration
status
5.5.9 If outside direct control check
before return to service
5.5.10 Where needed, intermediate
checks done
5.5.11 Correction factors correctly
updated
5.5.12 Safeguarded from adjustments
which would invalidate test and/or
calibration results.
5.6 Measurement traceability No requirements
5.6.1 General
All equipment having significant
effect on accuracy of results
calibrated before out into service.
Established program for
calibration of equipment.
5.6.2 Specific requirements No requirements
5.6.2.1 Calibration No requirements
5.6.2.1.1 Programme for calibration of
equipment ensures calibrations
and measurements made
traceable to International System
of Units (SI).
5.6.2.1.2 If cannot be strictly made to SI
units, traceability to appropriate
measurement standards
5.6.2.2 Testing No requirements

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5.6.2.2.1 If calibration contributes little to
uncertainty of test results,
equipment used can provide
uncertainty of measurement
needed.
5.6.2.2.2 Where traceability to SI units not
possible/relevant agreed methods
required (see 5.6.2.1.2)
5.6.3 Reference standards and No requirements
reference materials
5.6.3.1 Reference standards
Programme for calibration of
reference standards
5.6.3.2 Reference materials
Traceable to SI Units
5.6.3.3 Intermediate checks
Carried out to defined procedures
and schedules
5.6.3.4 Transport and storage
Procedure for safehandling,
storage and use of reference
standards
5.7 Sampling No requirements
5.7.1 Sampling plan if relevant

5.7.2 If customer requires differences,

recorded.
5.7.3 Procedures for recording sampling

5.8 Handling of test and calibration `

items
5.8.1 Procedures for transportation,
receipt, handling, protection,
storage, retention and/or disposal
of test/calibration items.
5.8.2 System for identifying test items

5.8.3 Recording of abnormalities or

departures recorded. Consultation
with client
5.8.4 Procedures for avoiding
deterioration, loss or damage to
items.
5.9 Assuring the quality of test and No requirements
calibration results
5.9.1 Procedures for monitoring validity
of tests.
5.9.2 Analyse and take appropriate
action on quality control data
that falls outside pre-defined
criteria
5.10 Reporting the results No requirements

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5.10.1 General
Results reported accurately,
clearly, unambiguously and
objectively.
5.10.2 Test reports and calibration No requirements
certificates
Shall include:
a) Title, eg test report

b) Name and address of laboratory

and location of tests if different
c) Unique identification, each page
identified, and clear indication of
end
d) Name and address of client

e) Identification of method used

f) Description, condition,
unambiguous identification of
item(s)
g) Date of receipt of items where
critical
h) Reference to sampling plan

i) Results with units of measurement

k) Where relevant statement result

relates only to items tested
5.10.3 Test results No requirements
5.10.3.1 In addition to 5.10.2 where
necessary:
a) Deviations, additions, exclusions
to test method, and specific test
conditions
b) Statement of compliance/non-
compliance
c) Where applicable, statement of
uncertainty
d) Where appropriate and needed,
opinions and interpretations
e) Additional information required by
specific methods, clients
5.10.3.2 In addition to 5.10.2 and 5.10.3.1
test reports containing sampling
contain additional information
5.10.4 Calibration certificates No requirements

5.10.4.1 Additional requirements for

calibrations certificates

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5.10.4.2 Calibration certificate relates only
to quantities and results of
functional tests. If statement of
compliance identify which clauses
met of not met
5.10.4.3 When instrument for calibration
adjusted or repaired, results after
reported
5.10.4.4 Calibration certificate not contain
recommendation on calibration
interval except if agreed with
client.
5.10.5 Opinions and interpretations
When opinions or interpretations
included, basis documented.
5.10.6 Testing and calibration results
obtained from subcontractors
When report contains results from
subcontractors, these are clearly
identified. When calibration
subcontracted, certificate to
contracting laboratory.
5.10.7 Electronic transmission of
results
In case of transmission of results
by telephone, telex, fax or similar,
requirements of this standard met
5.10.8 Format of reports and
certificates
Format designed to accommodate
each type of test and minimize
misunderstanding
5.10.9 Amendments to test reports and
calibration certificates
Material amendments after issue
made by further report containing
statement re supplement.
Amendments meet all
requirements of this standard.
When issue a complete new
report, it is uniquely identified and
references original it replaces.

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Annex A
CAB/ILAC joint Working Group
Common understanding of ISO/IEC 17025
Under the auspices of the IEC Conformity Assessment Board (CAB) and the International Laboratory
Accreditation Conference (ILAC), the JWG task is to collaborate in order to achieve a uniform and
common understanding of key elements of ISO/IEC 17025.
Extracted from ISO/IEC 17025
5.4.6.2 Testing laboratories shall have and shall apply
procedures for estimating uncertainty of measurement. In
certain cases the nature of the test method may preclude
rigorous, metrologically and statistically valid, calculation of
uncertainty of measurement. In these cases the laboratory
shall at least attempt to identify all the components of
uncertainty and make a reasonable estimation, and shall
ensure that the form of reporting of the result does not give
a wrong impression of the uncertainty. Reasonable
estimation shall be based on knowledge of the performance
of the method and on the measurement scope and shall
make use of, for example, previous experience and
validation data.
NOTE 1 The degree of rigor needed in an estimation of
uncertainty of measurement depends on factors such as:
the requirements of the test method;
the requirements of the client;
the existence of narrow limits on which decisions on
conformance to a specification are based.
NOTE 2 In those cases where a well-recognized test
method specifies limits to the values of the major sources of
uncertainty of measurement and specifies the form of
presentation of calculated results, the laboratory is
considered to have satisfied this clause by following the test
method and reporting instructions (see 5.10).
Extracted from ISO/IEC 17025
Test reports
5.10.3.1 In addition to the requirements listed in 5.10.2, test
reports shall, where necessary for the interpretation of the
test results, include the following:
a) deviations from, additions to, or exclusions from the test
method, and information on specific test conditions, such as
environmental conditions;
b) where relevant, a statement of compliance/non-
compliance with requirements and/or specifications;
c) where applicable, a statement on the estimated
OD/018/V3
June 2007
JWG Common Understanding
5.4.6.2 JWG-CU 1
test laboratories must have a
documented policy on the application of
measurement uncertainties, and must be
capable of estimating them.
5.4.6.2 JWG-CU 2
test laboratories (designated laboratory
staff) shall be able to demonstrate this
capability of calculating measurement of
uncertainty by providing examples of
typical measurements carried out in that
laboratory.
5.4.6.2 JWG-CU 3
For purely qualitative tests estimation of
measurement uncertainty is not
required. E.g. breaking capacity test on
Circuit Breakers.
5.4.6.2 JWG-CU 4
Test laboratories are not required to
recalculate uncertainties for each and
every test carried out.
JWG Common Understanding
5.10.3.1 JWG-CU 5
It is agreed that the wording “where
necessary” in relation of measurement
uncertainty is only related to the
examples provided in requirement under
c)
5.10.3.1 JWG-CU 6
It is agreed that the wording under c) “or
when the uncertainty affects compliance
to a specification limit” is meant that an
*estimate of measurement uncertainty
shall be stated and reported in the Test
Report.
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uncertainty of measurement; information on uncertainty is
needed in test reports when it is relevant to the validity or
application of the test results, when a client's instruction so
requires, or when the uncertainty affects compliance to a
specification limit;
d) where appropriate and needed, opinions and
interpretations (see 5.10.5);
e) additional information which may be required by specific
methods, clients or groups of clients.
Extracted from ISO/IEC 17025
Subcontracting of tests and calibrations
4.5.1 When a laboratory subcontracts work whether
because of unforeseen reasons (e.g. workload, need for
further expertise or temporary incapacity) or on a continuing
basis (e.g. through permanent subcontracting, agency or
franchising arrangements), this work shall be placed with a
competent subcontractor. A competent subcontractor is one
that, for example, complies with this International Standard
for the work in question.
4.5.2 The laboratory shall advise the customer of the
arrangement in writing and, when appropriate, gain the
approval of the client, preferably in writing.
4.5.3 The laboratory is responsible to the customer for the
subcontractor’s work, except in the case where the
customer or a regulatory authority specifies which
subcontractor is to be used.
4.5.4 The laboratory shall maintain a register of all
subcontractors that it uses for tests and/or calibrations and
a record of the evidence of compliance with this
International Standard for the work in question.
OD/018/V3
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*This estimated value may be a typical
value for that test.
JWG Common Understanding
4.5.1 JWG-CU 1
It is noted that while ABs can provide
accreditations for individual tests of a
product standard and/or a test method,
the IEC Schemes are assessing and
Recognizing a Testing Laboratory only if
the latter can demonstrate competence
and possess all required testing and
measuring equipment for that particular
standard in full.
For the operation of the IEC Schemes
certain tests which are rarely performed,
under certain conditions, may be
subcontracted on a permanent basis
according to the Rules of the IEC
Schemes.
For ABs assessments any test that is
not included in the accreditation
schedule is listed as being excluded
from the accreditation scope.
4.1 and 4.5.1 JWG-CU 2
For ABs assessments laboratories that
comprising for instance a main laboratory
and a satellite laboratory, with facilities that
are located (far) away from each other,
accreditation can be provided as a single
Laboratory’s entity if:-
a) these facilities form one legal
entity,
b) the accreditation is for the total
organisation,
c) there is one management system
covering the total organisation,
d) one person takes technical
responsibility for the final test
report issued,
e) there is adequate procedures in
place to protect the integrity of
the equipment under test,
f) the sequence of testing detailed
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Extracted from ISO/IEC 17025 JWG Common Understanding
in the product test standard is
not compromised.

Extracted from ISO/IEC 17025 JWG Common Understanding

4.12.2 Technical records 4.12.2.1 JWG-CU 1
I was noted that while ABs do require
4.12.2.1 The laboratory shall retain records of original retention of records in line with the
observations, derived data and sufficient information to Laboratory’s procedure the IEC
establish an audit trail, calibration records, staff records and Schemes requires retention of records
a copy of each test report or calibration certificate issued, following the period of validity of the
for a defined period. The records for each test or calibration relevant certificate.
shall contain sufficient information to facilitate, if possible,
identification of factors affecting the uncertainty and to
enable the test or calibration to be repeated under
conditions as close as possible to the original. The records
shall include the identity of personnel responsible for the
sampling, performance of each test and/or calibration and
checking of results.

NOTE  1 In certain fields it may be impossible or impractical

to retain records of all original observations.

NOTE  2 Technical records are accumulations of data (see

5.4.7) and information which result from carrying out tests
and/or calibrations and which indicate whether specified
quality or process parameters are achieved. They may
include forms, contracts, work sheets, work books, check
sheets, work notes, control graphs, external and internal
test reports and calibration certificates, clients' notes,
papers and feedback.

4.12.2.2 Observations, data and calculations shall be

recorded at the time they are made and shall be identifiable
to the specific task.

Extracted from ISO/IEC 17025 JWG Common Understanding

4.12.2.3
When mistakes occur in records, each mistake shall be Note: The requirement is self
crossed out, not erased, made illegible or deleted, and explanatory however it was agreed to re-
the correct value entered alongside. discuss its content at the next meeting
All such alterations to records shall be signed or initialled
by the person making the correction.

In the case of records stored electronically, equivalent

measures shall be taken to avoid loss or change of
original data.

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