Why Accredit Reference Materials Producers?

One of the key factors affecting laboratories' capabilities to produce reliable test data is the availability of reference materials with certified values that can be relied upon by their users.

Reference materials are widely used for the calibration of measuring instruments and for the evaluation or validation of measurement procedures. Their use makes possible the transfer of the values measured (or quantities assigned) between testing, analytical and measurement laboratories.

The demand for new reference materials of demonstrated and reliable quality is increasing as a consequence of both the increased precision of measuring equipment and the requirement for more accurate and reliable data in the scientific and technological disciplines. It is therefore not only necessary for reference material producers to supply information about these materials in the form of reports, certificates and statements, but also to demonstrate their competence in certifying reference materials of appropriate quality.

A number of international guides have been prepared through bodies such as ISO/REMCO to increase confidence in reliability of reference materials, including ISO Guide 34: 2000 Requirements for the production of reference materials.

Until recently, an internationally-recognised accreditation program for producers of reference materials did not exist. As a result of requests both from reference material producers and the National Standards Commission in Australia, NATA developed a program for accreditation of the competence of producers of reference materials.

How Does NATA Accredit Reference Materials Producers?

There are many different ways for producers to certify reference materials. These range from all functions being performed by a single organisation, through to various combinations of organisations conducting separate tasks leading to the production and certification of a reference -material. NATA considers that the organisation which is responsible for producing a reference material should ensure that all sub-tasks leading to its production have been performed competently, whether such tasks are carried out directly by the producer itself or in combination with various subcontractors.

Accordingly, it is the producer (and any subcontracting arrangements it uses) which NATA evaluates for competence in accordance with ISO Guide 34:2000 General Requirements for the Competence of Reference Matrials Producers.

Accreditation of a producer of reference materials is granted in terms of a defined scope of accreditation, which describes the specific types of reference materials which the producer is judged competent to produce. The scope of accreditation is negotiated with each applicant.

What are the Requirements for Accreditation?

NATA evaluates the reference materials producer, and any subcontracting arrangements it uses, against ISO Guide 34:2000 General Requirements for the Competence of Reference Materials Producers, which include the relevant elements of the ISO 9000 series of standardsw to eliminate the need for separate quality systems certification of a producer.

How Does NATA Evaluate the Competence of a Producer?

NATA evaluates a producer's compliance with the Requirements using assessment teams comprising technical experts and full-time NATA staff. In this respect it is similar to NATA's laboratory accreditation assessments. NATA is advised by a Reference Material Producers Accreditation Advisory committee in:

• the appointment of technical assessors
• the development and review of accreditation requirements and
• providing recommendations for granting and maintaining accreditation

This Committee comprises experts in reference material production, certification, supply and use.

How Can I Get Further Information?

If you have any further questions about this program, please do not hesitate to contact your nearest NATA office or NATA's Reference Material Producers Support Group.