«

»

Nov 15

Underpinning measurements: written standards

Reference materials are a type of measurement standard used to validate analytical methods, establish traceability and support quality control. They are particularly important for analytical chemistry and clinical analysis as most analytical instrumentation is comparative so samples of known composition (reference materials) are needed to ensure accurate calibration.

A reference material (RMs) can either be a pure substance, e.g. an immunosuppressant certified for purity, or a matrix material, e.g. ‘drinking water’ containing a range of commonly found compounds.

logo_isoThe development, production, and certification of reference materials are supported by a number of ISO (International Organization for Standardization) Guides. These guides, adopted by over 160 countries, ensure that materials, products, processes and services are fit for purpose. In order to maintain their relevance and ensure their appropriateness, ISO Guides are revised every 5 years.

LGC scientists working as part of our UK National Measurement Laboratory and Designated Institute for chemical and bio-measurement function provide the UK representation on the ISO Reference Materials Committee (REMCO) and the chair of the UK Reference Material Working Group. Within these committees we have taken a leading role in the latest revisions of the reference material guides ISO Guide 34 (General requirements for the competence of reference material producers) and ISO Guide 35 (Reference materials – General and statistical principles for certification).

To support the evolving regulatory needs with the reference material field, such as the introduction of national accreditation schemes for reference material producers, ISO Guide 34 has not only been revised but has also been converted to an international standard in the 17000 series. This series includes well known accreditation standards such as ISO17025.

LGC has been instrumental in the conversion process, leading and coordinating the views of UK stakeholders to inform the international position and providing comments throughout the drafting and production stages. The parallel contributions LGC has been making in writing, editing and commenting on the revisions to ISO Guide 35 have also informed the development of this new standard.

The new standard (ISO17034 – General requirements for the competence of reference material producers) was published at the beginning of this month (01 November 2016) and represents a global consensus for reference material production. It will benefit the UK through increased acceptance of our reference materials overseas.

The degree of input into the production and revision of the ISO Guides for reference material production demonstrates the level of impact LGC has in its role as the UK National Measurement Laboratory and Designated Institute for chemical and bio-measurement on the best practise in the field, maintaining the position of UK reference material producers at a global level.

 

LGC is accredited to Guide 34 as a Reference Material Producer.

All our materials are available from LGC Standards. For further information please contact uksales@lgcstandards.com

 

LGC, the UK National Measurement Laboratory and Designated Institute for chemical and bio-measurement

 

Leave a Reply

%d bloggers like this: