Key Topics

Reference material producer accreditation

Producers of reference materials supply products which form a critical part of their customers quality systems, and as such it is extremely important that the customer laboratories are able to trust the quality and reliability of the material which they purchase.

ISO guide 34, General Requirements for the Competence of Reference Material Producers was produced in 1996 by the ISO Committee on Reference Materials and revised in 2000. This document sets out the basis for accreditation of RM Producers. In 2004 an ILAC General Assembly passed a resolution for RM producers to be judged against not only ISO guide 34 but also to ISO/IEC 17025.

In 2005 a pilot scheme for accreditation of five UK RM Producers was launched by UKAS (United Kingdom Accreditation Service). The assessment of these RM Producers was completed in April 2006 and UKAS granted accreditation to the successful organisations on 30^th June 2006. Taken together these ISO standards cover the full range of RM producer activities, from planning and production control, assessment of homogeneity and stability, characterisation of the material’s properties, right up to post-distribution service.

UKAS formally launched the new accreditation service at an event held in the London Science Museum on 17^th July 2006.

Requirements for the RM producer

In order to gain accreditation, an RM producer must demonstrate competence in the following areas:

• planning
• production
• homogeneity testing
• stability testing
• characterisation
• certification
• customer service

Benefits

Accreditation of RM producers is of benefit to Reference Material users as it provides confidence in the competence of the producer to characterise and certify reference materials. UKAS has released a Technical Policy Statement (TPS 57) relating to the use of RMs by testing laboratories. This policy statement clearly states that the testing laboratory should use suitable reference materials where available and that the testing laboratory is responsible for ensuring the suitability of the Reference Material Producer.

“4.3 Laboratories are required to investigate the availability and suitability of reference materials and calibrated artefacts for their accredited procedures. The competence of organisations conducting the production or calibration of reference materials/artefacts is key to determining the suitability of the materials or artefacts. ISO/IEC 17025 requires laboratories to evaluate suppliers; this includes producers of reference materials and suppliers of calibration services/items. It is important that the laboratory determines the suitability of the producers of these items and not only the distributor.” – UKAS TPS 57

By choosing an accredited RM Producer, testing laboratories can significantly reduce the effort required to meet this requirement. This will reduce the administrative burden on testing laboratories and should lead to increased confidence in the quality of reference materials.

Resources

• A list of accredited reference material producers in the UK.
• UKAS TPS 57
• ISO guide 34 and ISO/IEC 17025 can be obtained from ISO