IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
Clause 8: Information requirements – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) MD 8.2.1: Document the scope precisely and exclude nothing that affects product safety and quality

What does MD 8.2.1 require?

The certification body documents the scope of certification precisely and does not exclude from it any processes, products or services that influence the safety and quality of the products, unless regulatory authorities allow the exclusion.

Maintained by Gerard Blokdyk

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