Specifying accreditation in regulations

 

by IAS Senior Vice President Raj Nathan

 
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Regulators in many different industries use accreditation to support their regulatory and policy objectives. For example, a regulator can support product safety mandates and ensure testing laboratories are competent to perform testing services by requiring that laboratories be accredited by an accreditation body such as IAS.

The following information, provided by the International Laboratory Accreditation Cooperation (ILAC), sets out how to accurately and fully specify the accredited services from external testing laboratories, covered by the ILAC Arrangement (MRA). All four items are needed to ensure that a lab providing external testing has met the relevant international standard and ILAC requirements for competence and are providing reliable data and reports. This text can be provided to regulators and specifiers to assist them in their drafting of regulations or specifications.

  • The laboratory shall be accredited in accordance with the requirements of ISO/IEC 17025 and include general requirements for the competence of testing and calibration laboratories.
  • The testing laboratory's scope of accreditation must comply with ISO/IEC 17025. General requirements for the competence of testing shall encompass testing of [here list the test method(s) or parameter(s) that are required for the testing work being required or specified].
  • The accreditation of a testing laboratory shall be issued by an accreditation body (AB), operating in accordance with ISO/IEC 17011, and must include general requirements for accreditation bodies accrediting conformity assessment bodies and signatory to the ILAC Arrangement.
  • Additional requirements can be laid down by the regulator (e.g. the lab must participate in specific proficiency testing programs).
The first paragraph stipulates that the service provider be accredited to ISO/IEC 17025, while the second paragraph requires that the tests requested be listed on the laboratory's scope of accreditation. If this requirement is not met, the laboratory could claim, for example, that it is ISO/IEC 17025 compliant even though it is not actually accredited for the tests specifically required.

The third paragraph stipulates that the AB should be an ILAC MRA signatory. (IAS is an ILAC MRA signatory.) It emphasizes the importance of using conformity assessment services accredited by an AB with the appropriate credentials without which it is not possible to be confident that the laboratory has been accredited by an AB competent to carry out the assessment. There are ABs that claim to be compliant with ISO/IEC 17011. Holding ILAC MRA signatory status indicates that the AB has been periodically peer-evaluated against the requirements of ISO/IEC 17011 and additional ILAC requirements.

For more information about specifying accreditation, contact IAS.