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PD ISO Guide 34:2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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General requirements for the competence of reference material producers

Available format(s)

Hardcopy , PDF

Superseded date

30-11-2016

Language(s)

English

Published date

31-01-2010

€306.17
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Organization and management requirements
5 Technical and production requirements
Annex A (informative) - Metrological traceability of
        certified property values of reference
        materials
Annex B (informative) - Commutability of reference
        materials
Annex C (informative) - ISO/IEC 17025/ISO Guide 34
        cross-reference table
Bibliography

Describes general requirements in accordance with which a reference material producer has demonstrate that it operates, if it is to be recognized as competent to carry out the production of reference materials.

Committee
RMI/1
DevelopmentNote
Supersedes BS PD6532-5(2000). (01/2010)
DocumentType
Standard
Pages
46
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO Guide 34:2009 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 Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials
CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
ISO Guide 33:2015 Reference materials — Good practice in using reference materials
ISO Guide 35:2017 Reference materials — Guidance for characterization and assessment of homogeneity and stability
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
ISO 3534-2:2006 Statistics — Vocabulary and symbols — Part 2: Applied statistics
ISO Guide 30:2015 Reference materials — Selected terms and definitions
CLSI EP32 R : 1ED 2006 METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 9001:2015 Quality management systems — Requirements
CLSI C53 P : 1ED 2008 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ECA ILAC G12 : 2000 GUIDELINES FOR THE REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIALS PRODUCERS
ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
ECA ILAC G24 : 2007 GUIDELINES FOR THE DETERMINATION OF CALIBRATION INTERVALS OF MEASURING INSTRUMENTS
ECA ILAC P10 : 2013 ILAC POLICY ON TRACEABILITY OF MEASUREMENT RESULTS
OIML D 10 : 2007 GUIDELINES FOR THE DETERMINATION OF CALIBRATION INTERVALS OF MEASURING INSTRUMENTS
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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