Name: EN ISO 17034:2016
Brand: CEN

General requirements for the competence of reference material producers (ISO 17034:2016)

Published date

30-11-2016

Publisher

Comite Europeen de Normalisation

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Structural requirements
6 Resource requirements
7 Technical and production requirements
8 Management system requirements
Annex A (informative) - Summary of production
requirements for RMs and CRMs
Bibliography

ISO 17034:2016 specifies general requirements for the competence and consistent operation of reference material producers.ISO 17034:2016 sets out the requirements in accordance with which reference materials are produced. It is intended to be used as part of the general quality assurance procedures of the reference material producer.ISO 17034:2016 covers the production of all reference materials, including certified reference materials.

Committee	CEN/CLC/JTC 1
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
UNI CEI EN ISO 17034 : 2017	Identical
PN EN ISO 17034 : 2017	Identical
NS EN ISO 17034 : 2016	Identical
NEN-EN-ISO 17034:2016	Identical
NF EN ISO 17034 : 2016	Identical
ISO 17034:2016	Identical
BS EN ISO 17034:2016	Identical
DIN EN ISO 17034:2015-12 (Draft)	Identical
SN EN ISO 17034 : 2017	Identical
I.S. EN ISO 17034:2016	Identical
UNE-EN ISO 17034:2017	Identical
DIN EN ISO 17034:2017-04	Identical
SS-EN ISO 17034:2016	Identical
CEI UNI EN ISO 17034 : 1ED 2018	Identical

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO/IEC 17000:2004	Conformity assessment Vocabulary and general principles
ISO 15195:2003	Laboratory medicine Requirements for reference measurement laboratories
ISO 15194:2009	In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation
ISO 15189:2012	Medical laboratories — Requirements for quality and competence
ISO/TR 16476:2016	Reference materials — Establishing and expressing metrological traceability of quantity values assigned to reference materials
ISO Guide 35:2017	Reference materials Guidance for characterization and assessment of homogeneity and stability
ISO/IEC 17011:2004	Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies
ISO/IEC Guide 99:2007	International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO Guide 30:2015	Reference materials Selected terms and definitions
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO Guide 31:2015	Reference materials — Contents of certificates, labels and accompanying documentation
ECA ILAC P10 : 2013	ILAC POLICY ON TRACEABILITY OF MEASUREMENT RESULTS
ISO/IEC Guide 98-3:2008	Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)