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Accreditation Requirements - Management Systems for Medical Device Manufacturers
Useful information
Type of Publication:
Accreditation documents and guidance
Document Date:
2024-05-17
Accreditation requirements for certification bodies certifying medical devices management systems
- IAF MD 9:20232 – Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)
Certification standards
• ISO 13485:2016
Accreditation requirements for all management systems certification bodies
- ISO/IEC 17021-1:2015 – Conformity assessment – Requirements for bodies providing audit and certification of management systems -- Part 1: Requirements
- IAF MD 1:2023 – IAF Mandatory Document for the Certification of Multiple Sites Based on Sampling
- IAF MD 2:2023 – IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems
- IAF MD 4:2023 – IAF Mandatory Document for the Use of Information and Communication Technology (ICT) for Auditing/Assessment Purposes
- IAF MD 11:2023 – Application of ISO/IEC 17021-1 for Audits of Integrated Management Systems (applies only to CBs certifying to multiple certification standards)
IAF MD 23:2023 – Control of Entities Operating on Behalf of Accredited Management Systems Certification Bodies