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» Evaluation Process

Acceptance of an accreditation body into the ILAC MRA is dependent upon being successfully evaluated by peers from other accreditation bodies in accordance with the relevant rules and procedures contained in ILAC publications. Each accreditation body that is a signatory to the ILAC MRA commits to:

  • Maintain conformity with the current version of ISO/IEC 17011 Conformity assessment – General requirements for bodies providing assessment and accreditation of conformity assessment bodies and supplementary requirements documents.
  • Ensure that all laboratories that are accredited comply with appropriate laboratory standards (currently ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories and ISO 15189 Medical Laboratories – Requirements for quality and competence).
  • Ensure that all inspection bodies that are accredited comply with appropriate inspection standards (currently ISO/IEC 17020 Conformity Assessment – Requirements for the operation of various types of bodies performing inspection).

The ILAC MRA is based on the results of an intensive evaluation carried out in accordance with the relevant rules and procedures contained in several ILAC publications. The evaluation of an accreditation body to establish its qualifications to be an ILAC Full Member (ILAC MRA signatory) involves a team of peers, generally senior staff of experienced accreditation bodies.

Evaluations include time spent at the headquarters office of the applicant body to determine compliance with ISO/IEC 17011. Additionally, the evaluators witness the performance of the applicant’s assessors during actual assessments/reassessments to determine if the laboratories and inspection bodies are in compliance with ISO/IEC 17025 or ISO 15189 or ISO/IEC 17020 and that there is sufficient depth of examination to determine competence.

ILAC delegates authority to its Recognised Regional Cooperation Bodies for the evaluation, surveillance, re-evaluation and associated decision making relating to the signatory status of the accreditation bodies that are ILAC Full Members (ILAC MRA signatories). Accreditation bodies that cannot be affiliated with a Recognised Regional Cooperation Body may apply directly to ILAC for evaluation and recognition.

In order to maintain the value and meaning of the ILAC MRA, the signatories agree to notify each other about any significant changes in the status or operation of the accreditation body. Issues of significance include changes in name or legal/corporate status; new agreements negotiated with other accreditation bodies or the revision, suspension or termination of any such agreements; changes in key senior staff or the organisational structure; or significant changes in the operations of the body. Each signatory to the ILAC MRA must also designate a liaison officer to afford a consistent channel of communication between the accreditation bodies.

ILAC MRA 2016 Annual Report provides information on the activities carried out as part of the peer evaluation process in 2016 to ensure that regulators and consumers of laboratory and inspection data are able to maintain confidence in the results produced under the ILAC MRA.

 

Further information:

The ILAC Mutual Recognition Arrangementpromotional-brochures-Route_to_Signing
The ILAC Mutual Recognition ArrangementThe route to signing the IAF or ILAC Arrangements