IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies
Clause 7: Process requirements – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies

IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies MD 7.9.3: Run surveillance and reassessment with annual office and witness assessments covering every main technical area in the cycle

What does MD 7.9.3 require?

Surveillance and reassessment include on-site, remote or combined assessment methods and may include witnessing and office review. Unless regulations require otherwise, the surveillance office assessment and witness assessment take place at least once a year. Over an accreditation cycle the witnessing programme covers at least one audit from each main technical area of Annex 1 within the scope before the accreditation expires, gives priority to the higher-risk technical areas, should avoid repeatedly witnessing the same certified client, and takes previous witnessing results into account in the witness strategy.

Maintained by Gerard Blokdyk

Other controls in Clause 7: Process requirements – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies

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