Scope of Accreditation for ISO 13485 is defined to Annex 1 of IAF MD8:2017. The category 1.7 (parts or services) has explicit reference to Calibration Services along with the note “Organizations providing calibration services should be accredited to ISO/IEC 17025”. (We consider that Organizations providing calibration services shall be accredited to ISO/IEC 17025.) This IAF MD8 reference can easily create confusion to people who are not fully aware about the difference of accreditation and accredited certification.
Question
Is it ok for a NAB not to accept accreditation for calibration services based on ISO 13485?
September 2018
Accreditation of calibration services shall be made to ISO 17025. A NAB can not use ISO 13485 to accredit calibration services. EA and ILAC MLA for calibration are based on ISO 17025
The NOTE tries to explain that situation.
The accreditation of a CB according to ISO 17021 to certify ISO 13485 is limited to certification services and is not intended for accreditation (for example a testing lab may be certified to ISO 9001 under accreditation and this does not mean that is accredited for testing).
It should be also remembered:
Annex 1: IAF-ILAC JGA 2007 Sydney Resolution 7 – Certification to accreditation standards The IAF and ILAC Joint General Assembly, acting on the recommendation of the JCCC, resolves that when a Conformity Assessment Body (CAB), accredited by an Accreditation Body (AB), is providing certification to any standard used as a basis for accrediting CABs (e.g. ISO/IEC 17025 or ISO 15189), the AB shall initiate its process for suspension of accreditation, as this behaviour of the CAB will put the AB, against its will, in the condition of providing the same service that a CAB performs, in violation of clause 4.3.6 of ISO/IEC 17011. Further decisions shall be based on the actions taken by the CAB. All IAF and ILAC AB members shall include a suitable provision on such a possibility in their contracts with CABs. Note: It is accepted that a CAB may have to assess subcontractors to confirm that they meet the CABs’ requirements, which may include accreditation standards e.g. ISO/IEC 17025. Documentation issued to subcontractors as a result of a successful assessment should clearly state that this is only for the purposes of the subcontract and is not certification or accreditation in accordance with ISO/IEC 17011.