Transforming ISO Guide 34 into ISO 17034

General requirements for the competence of reference material producers

CASCO/REMCO Joint Working Group 43

 ISO Guide 34 - Brief History

 1996 - ISO Guide 34 developed by ISO/REMCO

 2000 - REMCO having a mandate to develop Guides

related to Reference Materials

 2009 - Third edition ISO Guide 34:2009 already

based on ISO/IEC 17025 and used for accreditation
REMCO ‘family’ deliverables structure

ISO Guide 33 Chemical purity

proper RM use
ISO Guide 35
establishing RM CRMs
characteristics

ISO Guide 80 Homogeneity

in-house preparation ISO Guide 34/ and stability
in-house RMs
ISO 17034
requirements for 'RMP
competence'
TR 79 ISO Guide 31
RM documentation
RMs for qualitative ISO Guide 30
properties RM terminology

TR 16476
Traceability & RMs TR 10989
RM categorization
TR 11773
RM distribution
 Transformation - brief summary
 Creation in 2014 of a Joint Working Group (JWG43), to transform ISO
Guide 34 into an International Standard

 Composition of the JWG:

• Convenor: Dr Stefanie Trapmann (JRC EC)
• REMCO experts (members & liaisons): 29
• CASCO experts (members & liaisons): 21

 Key development stages:

• Draft International Standard (DIS), 2015
• Final Draft International Standard (FDIS), 2016
• Publication, November 2016
 Requests for a 17000 standard, WHY?

 Specific situation in Europe:

Regulation (EC) No 765/2008 setting out requirements for

accreditation and market surveillance relating to the marketing
of products:
• National Accreditation bodies (NAB)
• Accreditation (only) based on Harmonised International
Standards
 Requests for a 17000 standard, WHY?
 Situation in the rest of the world:
• Some ABs could not accredit to ISO Guide 34
• Used in combination with ISO/IEC 17025 in some countries
• ILAC had been developing further guidance for the Guide
• Alignment with ISO/IEC 17025 and to some extent ISO/IEC
17043
• Some regions have MRAs for accreditation
• ILAC MRA will also be established
 Transforming ISO Guide 34 into ISO 17034
CASCO/REMCO meetings: REMCO
 1st JWG43 meeting, December 2014, Geneva support:
• CD balloting (90 % in favour, 1042 comments)
AHG 03
 2nd JWG43 meeting July 2015, Geneva preparation of
• DIS balloting (96 % in favour, 1543 CD
comments) CAG comments
and input
 Drafting Group meeting, February 2016, Geneva

 3rd JWG43 meeting, April 2016, Geneva

• FDIS balloting (100 % in favour)
 Key changes
• ISO Guide converted into International Standard
• Common structure of ISO/IEC 17000 series applied
• Based on ISO/CASCO PROC 33 (common elements of ISO/CASCO standards)
• Requirements for the production of all types of RMs and specific
requirements for CRMs
• Harmonised with revisions of
• ISO Guide 30 (terms and definitions)
• ISO Guide 31 (content of certificates and documentation)
• ISO Guide 35 (characterization, assessment of homogeneity and
stability)
• also ISO/IEC 17025 (under revision itself!)
• Normative references to ISO Guides 30, 31 and 35 removed (requirements
added)
• Provides more details on required RM documentation
• Addresses risks and opportunities
 What does this mean in practice?
 Requirements for the production of all types of RMs:
RMs (including specific type of RMs such as proficiency testing samples and
CRMs) are covered.

 Harmonised with revisions of other REMCO Guides and normative references to

ISO Guide 30, 31 and 35 removed:
• ISO 17034 stipulated requirements (shall), ISO/REMCO Guides give
recommendations (should) which ensure compliance with ISO 17034.
• The RMP shall select a characterization strategy appropriate for the
intended use of the RM (approaches proposed but not mandatory).

 Harmonised with ISO/IEC 17025:

Relevant ISO/IEC 17025 requirements are mandatory.

 More details on required RM documentation:

Required information on the RM document (certificate or product information
sheet).
JWG 43 (in 2015)