General requirements for the competence of reference material producers

General requirements for the competence of reference material producers

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What is ISO 17034 - Requirements for material producers about?  

ISO 17034 is an international standard that focuses on general requirements for the competence of reference material producers. Reference material producers can accredit some or all of the reference materials produced. ISO 17034 specifies general requirements for the competence and consistent operation of reference material producers. ISO 17034 sets out the requirements by which reference materials are produced. ISO 17034 is intended to be used as part of the general quality assurance procedures of the reference material producer. 

Who is ISO 17034 - Requirements for material producers for? 

ISO 17034 on general requirements for the competence of reference material producers is useful for: 

  • Reference material producers 
  • Regulatory authorities 
  • Accreditation bodies 
  • The professionals who are involved in peer assessment 

Why should you use ISO 17034 - Requirements for material producers 

Reference material (RMs) are used in all stages of the measurement process, including for method validation, calibration, and quality control. They are also used in interlaboratory comparisons for method validation and for assessing laboratory proficiency. ISO 17034 provides a demonstration of the scientific and technical competence of reference material producers (RMPs) is a basic requirement for ensuring the quality of RMs. ISO 17034 outlines the general requirements for the producers of RMs, including certified reference materials (CRMs).  ISO 17034 ensures the competence of all personnel, including technical management personnel, operating under its management system who undertake activities relating to the production of each particular type of RM. Using ISO 17034 you can specify general requirements for the competence and consistent operation of reference material producers. 

What’s changed since the last update?  

BS EN ISO 17034:2016 supersedes PD ISO Guide 34:2009. BS EN ISO 17034:2016 includes some technical changes concerning PD ISO Guide 34:2009. These include: 

  • Inclusion of requirements for the production of all types of reference materials, and additional specified requirements for certified reference materials 
  • Harmonization with the revisions of ISO Guide 31 and ISO Guide 35 
  • Inclusion of more details on required reference material documentation 
  • Inclusion of risks and opportunities