ISO/IEC 17025

Technical Requirements

Steve Thorpe
 ISO 17025
• History and ‘philosophy’ of the new
Standard
• The most important technical changes in the
Standard
• How these changes affect laboratory
operations and procedures
 History of ISO 17025
• Replaced NAMAS M10, M11 and M10
(Supplement) in the UK
• Replaced ISO Guide 25 and EN 45001
internationally
• The above Standards date from the 1980’s and
early 1990’s and it was recognised that they were
outdated
• ISO 17025 is a truly International Standard and (at
least in my opinion) a much improved Standard
 ‘Philosophy’ of ISO 17025 (1)
• Less prescriptive than earlier standards -
greater responsibility on labs to define the
requirement according to ‘fitness for
purpose’
• More forward looking
• More emphasis on meeting client
requirements
 ‘Philosophy’ of ISO 17025 (2)
• Much of the ‘thinking’ comes from the ISO
9000 Series of Standards
• ‘Testing and calibration laboratories that
comply with this International Standard will
therefore also operate in accordance with
ISO 9001 or ISO 9002’
 UKAS implementation of ISO
17025
• All new assessments and surveillance visits
since April 2001 have been to the 17025
Standard
• UKAS requires all its accredited labs to
have transferred to 17025 by June 2002 at
the latest (i.e. NOW!!)
 Structure of ISO 17025
•Two main sections
- section 4 - management requirements
- section 5 - technical requirements
- many sections also have ‘notes’

This talk will concentrate on certain technical

requirements which were either not present or
were less detailed in the earlier M10 Standard
‘New’ technical requirements of
ISO 17025 (additional to M10)

5.4.5 Validation of methods

5.4.6 Estimation of uncertainty of measurement

5.9 Assuring the quality of test results

 5.4.5 Validation of methods (1)
• In my opinion the strongest part of the new
Standard
• Validation was not mentioned in M10
• Now clear that the primary responsibility to
decide on ‘fitness for purpose’ lies with the
lab (not the assessor)
5.4.5 Validation of methods (2)

‘Validation is the confirmation by

examination and the provision of
objective evidence that the particular
requirements of a specific intended use
are fulfilled.’
(ISO 17025, 5.4.5.1)
5.4.5 Validation of methods (3)

‘The validation shall be as extensive as is

necessary to meet the needs of the given
application or field of application. The
laboratory shall record the results obtained, the
procedure used for the validation, and a
statement as to whether the method is fit for the
intended use.’
(ISO 17025, 5.4.5.2)
5.4.5 Validation of methods (4)

Fitness for Purpose

‘The degree to which data produced by a
measurement process enables a user to
make technically and administratively
correct decisions for a stated purpose.’
(IUPAC)
 5.4.5 Validation of methods (5)
• Process of ‘validation’
- identify the purpose of the test
- review any existing method performance data
- plan a programme of additional experimental work
- carry out the above programme
- review the data
- confirm ‘fitness for purpose’
• Most labs have probably always done most, if not all, of
the above, but the process must now be formalised
 5.4.5 Validation of methods (6)
• Validation is an on-going process!!
• The validation ‘file’ should never be closed
• Method performance needs to be
continually up-dated and reviewed in the
light of routine QC data and proficiency
testing results
 5.4.6 Estimation of Uncertainty
of Measurement (1)

• Probably the biggest cause of concern to labs in

the new Standard (but is this concern largely
unfounded?)
• ‘Estimation’ not ‘Determination’ or ‘Quantitation’
• Wording is not dramatically different to M10 but
UKAS is placing greater emphasis on uncertainty
 5.4.6 Estimation of Uncertainty
of Measurement (2)
• Labs must have a procedure for estimation
of uncertainty
• An estimation of the uncertainty is required
in test reports if a) the client requests it; b)
when it may be relevant to the validity or
application of the results or c) when it may
affect compliance to a specification limit
5.4.6 Estimation of Uncertainty
of Measurement (3)

Reproduced from Eurachem / CITAC Guide

5.4.6 Estimation of Uncertainty
of Measurement (4)

available for download free from www.eurachem.org

 5.4.6 Estimation of Uncertainty
of Measurement (5)
• Worked examples (not necessarily
correct!!) are available at
www.measurementuncertainty.org
5.9 Assuring the Quality of Test
Results
• Note that the Standard is not prescriptive –
it is the responsibility of labs to plan and
review appropriate quality control measures
• New requirement to ‘record data in such a
way that trends are detectable and, where
practicable, apply statistical techniques to
the reviewing of results’
and finally …. to stir things up!!

Common (?) criticisms

•Insufficient flexibility
•Inconsistencies between assessors
•Others?
Personal view that neither of the above is a fair
criticism, but there is a forum for discussion later!