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I.S. EN ISO 17034:2016

Current

Current

The latest, up-to-date edition.

GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS (ISO 17034:2016)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

Preview

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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

US$59.06
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National Foreword
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

Defines general requirements for the competence and consistent operation of reference material producers.

DocumentType
Standard
Pages
42
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
EN ISO 17034:2016 Identical
ISO 17034:2016 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)

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