I.S. EN ISO 17034:2016
Current
The latest, up-to-date edition.
GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS (ISO 17034:2016)
Hardcopy , PDF
English
01-01-2016
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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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