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

Standard No.

ISO 17034:2016

Release Date

2016

Published By

International Organization for Standardization (ISO)

Latest

ISO 17034:2016

Scope

This International Standard specifies general requirements for the competence and consistent operation of reference material producers. This International Standard 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. This International Standard covers the production of all reference materials, including certified reference materials. NOTE Reference material producers, regulatory authorities, organizations and schemes using peer assessment, accreditation bodies and others can also use this International Standard in confirming or recognizing the competence of reference material producers.

ISO 17034:2016 Referenced Document

• ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment
• ISO 15189:2012 Medical laboratories - Requirements for quality and competence
• 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 15195:2003 Laboratory medicine - Requirements for reference measurement laboratories
• ISO 9000:2015 Quality management systems - Fundamentals and vocabulary
• ISO Guide 30:2015 Reference materials - Selected terms and definitions
• ISO Guide 31:2015 Reference materials - Contents of certificates, labels and accompanying documentation
• ISO Guide 35:2006 Reference materials - General and statistical principles for certification
• ISO/IEC 17000:2004 Conformity assessment - Vocabulary and general principles
• ISO/IEC 17011:2004 Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies
• ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
• ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
• ISO/IEC Guide 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)
• ISO/TR 16476:2016 Reference materials - Establishing and expressing metrological traceability of quantity values assigned to reference materials

ISO 17034:2016 history

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