REVISION OF STANDARD ISO/IEC 17025

AND INTERLABORATORY COMPARISONS

Dr. Peter Ulbig

Chairperson of DKD steering committee
Head of Division
for Scientific-technical cross-sectional tasks
 Die Entwicklung
The history of ISO/IEC des17025
DKD

• ISO/IEC 17025 was first released in 1999

• Based on ISO Guide 25:1990

– Originally published in 1978
– Labeled a guide originally
– CASCO was not given the authority to publish
International Standards until late 1980’s

• ISO/IEC 17025 was reportedly a difficult standard to

gain consensus on, some parts had to be made
generic as a result
– 5.10.4.2 taking measurement uncertainty into account
when statements of compliance are made

Page 2 of 30
 Die Entwicklung
The history of ISO/IEC des17025
DKD

• In 2005, ISO/IEC 17025 had minor revision to

harmonize with ISO 9000:2000

• The most significant change was to add in a new

section 4.10, Improvement

• The term improve or improvement was also added to

4.1.5, 4.2.2.e, 4.7.2, 4.12.1, 4.15.1

• In 2010, the vote was to reaffirm without changes

– Most vocal supporter of this was the ILAC Laboratory
Committee

Page 3 of 30
Present Die Entwicklung
status des DKD
of ISO/IEC 17025

• ISO/IEC 17025 is now 16 years old

• Management requirements are still broadly

based on ISO 9000:1994 while ISO 9000 has
been revised in 2000, 2008, and 2015

• There is concern that some laboratories have

learned how to exploit weaknesses in the
standard

Page 4 of 30
Present Die Entwicklung
status des DKD
of ISO/IEC 17025

• The VIM has had significant revisions since the 1993 version that was
used for ISO/IEC 17025, causing confusion regarding compliance to the
standard

• The original standard was written in a time where quality systems were
distributed on paper, and computers were rarely used to distribute the
quality system, making the standard appear dated

• Other references to “facsimile and Telex”, outdated technology

• WWW “wasn’t a thing” in 1999

Page 5 of 30
ISO/IEC Die Entwicklung
17025 des DKD
– A time for Change?

• In October 2013, The ILAC LC proposed to the

General Assembly that a work item be
submitted to CASCO to revise ISO/IEC 17025
as soon as practicable

• Some accreditation bodies requested a 90 day

consultation period with their accredited
laboratories commencing on Nov 1, 2013

Page 6 of 30
 Diein
Activities Entwicklung
2014 des DKD

• February 1 – a letter ballot to ILAC members was

distributed to vote on the motion
– 30 day ballot
– Required 75% affirmative vote to require revision

• March – result of the vote was 84% affirmative

• March – ILAC and South Africa proposed New

Work Item Proposal on revision of ISO/IEC 17025
Finally international majority for revision

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 Die Entwicklung
The revision process des DKD
of ISO/IEC 17025

• The scope requires revision and updating to cover new areas

• ISO/IEC 17025 takes a prescriptive approach and is out of step

with the modern standards approaches which are performance-based
or process-based. The formatting should also be matched to newer
standards such as ISO 9001, ISO 15189, ISO/IEC 17020, ISO/IEC 17043,
ISO/IEC 17021, ISO/IEC 17065

• Impartiality needs to be addressed in a more informed way

• Subcontracting circumstances need to be clarified

(reference to how this is handled in ISO/IEC 17043 would be helpful)

• Traceability requirements should be expanded/clarified along more

informed lines

Page 8 of 30
 Die Entwicklung
The revision process des DKD
of ISO/IEC 17025

• Structure will be changed

• ILAC policy papers

P9 Participation in proficiency testing activities
P10 Traceability of measurement results
P14 Uncertainty in calibration
may be introduced

• Calibration and testing labs “labs”

• Introduction of an electronic calibration certificate?

Page 9 of 30
 Die Entwicklung
The revision process des DKD
of ISO/IEC 17025

Page 10 of 30
 Die Entwicklung
The revision process des DKD
of ISO/IEC 17025
End of August 2015:
First Committee Draft (CD) for 2 months to give comments

Approx. February 2016:

Release of DIS

End of 2016:
Publication of new version of ISO/IEC 17025

99 Experts are working on the 1st CD

(high fraction coming from developing countries)

worldwide approx. 43000 testing labs

(in Germany about 2800)
Page 11 of 30
 Die Entwicklung
The revision process des DKD
of ISO/IEC 17025

1st CD will be distributed by EUROCAL among all

accredited calibration labs of its members

High interest in obtaining feedback on the 1st CD

Exchange of opinions within EUROCAL

EUROCAL could give comments

Page 12 of 30
 Die Entwicklung
The revision of the GUMdes DKD

Freely downloadable as
all other JCGM documents

Page 13 of 30
 Die Entwicklung
The revision of the GUMdes DKD

• many people use a coverage factor of 2, even if

the preconditions the probability density function
are not fulfilled
more need for Monte Carlo calculations!

• corrected formula for the calculation of

the standard uncertainty:

Page 14 of 30
 Die Entwicklung
The revision of the GUMdes DKD

• proposed changes may lead to higher measurement

uncertainties in several cases

• NMIs may need to recalculate their CMCs

• also accredited calibration labs may need

to recalculate their measurement uncertainties

Most DKD TC chairs refused the draft

Even if the draft seems justified, PTB refused

the draft, too, but would accept it e.g. with a large
transposition period to prepare for all the changes
Page 15 of 30
 Die Entwicklung
Laboratory des DKD
intercomparisons: ISO/IEC 17025

ISO/IEC 17025:2005 (sub-clause 5.9) establishes that:

the laboratory shall have quality control procedures for

monitoring the validity of tests results and that this
monitoring shall be planned.

Among others, the standard refers to participation

in Proficiency Testing (PT) as one of the tools
laboratories may use to achieve this objective.

But in which areas and with which frequency?

Page 16 of 30
 Die Entwicklung
Laboratory des DKD
intercomparisons: ILAC P9

Page 17 of 30
 Die Entwicklung
Laboratory des DKD
intercomparisons: ILAC P9

4.2 The minimum PT activity according to a laboratory’s

or inspection body’s (where relevant) scope is:

• evidence of satisfactory participation prior to gaining

accreditation where PT is available and appropriate

• further and ongoing activity that is appropriate to the

scope of accreditation and consistent with the PT
participation plan.

Page 18 of 30
 Die Entwicklung
Laboratory des DKD
intercomparisons: ILAC P9

4.6 It is recognised that there are areas of testing and

calibration for which suitable PT does not exist or is
not practical.

In such cases, the accreditation body and the

laboratory or where relevant the inspection body shall
discuss and agree on suitable alternative means by
which performance can be assessed and monitored.

This would need to be considered as part of the

planned PT and/or related activities.

Page 19 of 30
 Die Entwicklung
Laboratory des DKD
intercomparisons: EA-4/18

Page 20 of 30
 Die Entwicklung
Laboratory des DKD
intercomparisons: EA-4/18

First step:
Identification of „sub-disciplines“ that apply to the labs

a sub-discipline may contain more than measurement

technique, but it should generally contain no different
technical competences

Second step:
Definition of „level of participation“ (= frequency)

at least one reaccreditation cycle should be covered

Page 21 of 30
 Die Entwicklung
Laboratory des DKD
intercomparisons: DAkkS 71 SD 0 010

(„Inclusion of proficiency testing in accreditation“)

Page 22 of 30
 Die Entwicklung
Laboratory des DKD
intercomparisons: DAkkS 71 SD 0 010

„Laboratories … are requested to take part in

proficiency testing activities successfully if such are
available and technically and economically appropriate.“
Responsibility of the lab!

„The DAkkS requests successful participation in at least

one proficiency test … in every defined sub-discipline
in the period between the initial accreditation and the
first reaccreditation or between two reaccreditations.“

Page 23 of 30
 Die Entwicklung
Laboratory des DKD
intercomparisons

Definition of sub-disciplines by DKD TCs and

DAkkS sector committees is going on right now.

DKD aims to write a document for all DKD-TCs

where the sub-disciplines are given.

But what are the possibilities how to perform

a proficiency test resp. an intercomparison?

Page 24 of 30
DifferentDiekinds
Entwicklung des DKD
of intercomparisons

1. Intercomparison performed by PTB:

- working standard calibrated by PTB

- intercomparison organised by PTB

- intercomparison results analysed and

documented by PTB

intercomparisons were executed this way for

many years, but nowadays only in a few cases,
due to lack of resources.

Page 25 of 30
DifferentDiekinds
Entwicklung des DKD
of intercomparisons

2. Intercomparison performed by one leading

accredited calibration lab:

- working standard calibrated by PTB

- intercomparison organised by one lab

- intercomparison results analysed and

documented by this lab

works, but one lab gets overview over all

participating competitors

Page 26 of 30
DifferentDiekinds
Entwicklung des DKD
of intercomparisons

3. Intercomparison performed by an accredited

proficiency test provider (ISO 17043):

- use of working standard given by PTB or use

of a traceable working standard of the PT provider

- intercomparison organised by the PT provider

- intercomparison results analysed and

documented by this PT provider

works, but needs a PT provider for this

sub-discipline and costs money

Page 27 of 30
DifferentDiekinds
Entwicklung des DKD
of intercomparisons

4. Intercomparison performed by one accredited

calibration lab as a member of a group of
several accredited calibration labs:

- use of a traceable working standard given by

one accredited calibration lab with sufficient
measurement uncertainty

- intercomparison organised by one lab

- intercomparison results analysed and

documented by one lab
works, but needs trust (and best done acc. to 17043)
Page 28 of 30
DifferentDiekinds
Entwicklung des DKD
of intercomparisons

5. „Intercomparison“ performed by an assessor

before or during an assessment:

- use of a traceable working standard given by

the assessor

- assessor observes calibration of the working

standard performed by the lab

- results analysed and documented by the assessor

useful in areas, where the number of labs is very

low or the measuring range is not common

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Current Die Entwicklung
situation des DKD
in Germany

In Germany all kinds of intercomparisons are used.

As PTB is responsible for unity of measurement

in Germany, working standards have to be traceable
to the SI, not necessarily to PTB.

ISO/IEC 17043 represents a very good basis for

the execution of an intercomparison.

many German laboratories start right now

to establish a PT programme

Page 30 of 30
Physikalisch-Technische Bundesanstalt
Braunschweig und Berlin
Bundesallee 100
38116 Braunschweig
Dr.-Ing. habil. Peter Ulbig
Division Q „Scientific-technical cross-sectional tasks“
Chairperson of Deutscher Kalibrierdienst (DKD)
Telephone: 0531 592-8010
E-Mail: Peter. Ulbig@ptb.de
www.ptb.de