Reference Material Producers (ISO 17034) Accreditation

ISO 17034 defines general requirements for the competence of reference material producers. This is an ACCREDITATION scope, not a certification: the producer is assessed by an accreditation body party to the ILAC MRA. A reference material is a material with properties sufficiently homogeneous and stable to ensure traceability of measurement results and comparability between laboratories.

• Organisations producing certified reference material (CRM)
• Providers preparing proficiency-testing (PT) samples
• Producers of calibration solutions and standard gases
• Large organisations producing their own in-house reference material and distributing it to their laboratories

Not mandatory; but because accredited laboratories must ensure measurement traceability under ISO/IEC 17025, they prefer to obtain material from ISO 17034-accredited producers. This makes accreditation effectively a market-entry condition.

• Impartiality, confidentiality and structural requirements
• Resource requirements: personnel competence, facilities and environmental conditions, equipment
• Production planning and production control
• Material processing, homogeneity and stability assessment
• Characterisation and assignment of property values
• Calculating measurement uncertainty and metrological traceability
• The reference material certificate and documentation content
• Management system requirements

1. 1Preparation and Scope DefinitionThe test/calibration methods for which accreditation is sought and their measurement uncertainties are listed.
2. 2Establishing the Quality SystemDocumentation, personnel competence records, equipment traceability and method-validation records are established against the standard's management and technical requirements.
3. 3Proficiency Testing and ComparisonsParticipation is demonstrated in proficiency testing (PT) or interlaboratory comparison for the methods within scope.
4. 4Applying to the Accreditation BodyApplication is made to an accreditation body party to the ILAC MRA; an on-site assessment is scheduled following document review.
5. 5On-site AssessmentA team of a lead assessor and technical experts assesses every method within scope at the level of technical competence.
6. 6Accreditation Decision and Publishing the ScopeAccreditation is granted once nonconformities are closed, and the scope is published on the accreditation body's public list.
7. 7Interim AssessmentsPeriodic surveillance is carried out during the accreditation cycle, and a reassessment at the end of the cycle.

The accreditation cycle runs under the rules of the accreditation body applied to; common practice is periodic surveillance assessments within a four-year cycle. A change of scope (adding a new method) requires a separate application.

• The list of methods and scope for which accreditation is sought
• Measurement-uncertainty calculations
• Personnel competence and training records
• The equipment inventory and calibration-traceability records
• Method verification/validation records
• Proficiency-testing (PT) participation results

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of methods within scope
• The number of technical-expert fields needed for the assessment
• The number of sites and laboratories
• Proficiency-testing participation costs
• The accreditation body's own fee schedule

This standard is not a certification, but an ACCREDITATION scope: an accreditation body evaluates the laboratory, not a certification body. Mutual recognition between accreditation bodies is achieved through the ILAC MRA; Accredited coverage can be verified from the accrediting body's publicly available list.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• ISO 9001Quality Management System
• ISO 10002Customer Satisfaction and Complaint Management
• ISO 10004Customer Satisfaction Monitoring and Measurement
• ISO 10012Measurement Management System
• ISO 13485Medical Device Quality Management
• ISO 15378Pharmaceutical Primary Packaging Quality Management
• ISO/IEC 17025Testing and Calibration Laboratories
• ISO 21001Educational Organizations Management