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Brochure: The IAF Initiative for Accredited Certification to ISO 13485 - Medical Devices
How ISO 13485 certification relates to product certification
Although an audit performed under the ISO 13485 may include an examination of a product’s design and development, ISO 13485 is not a product certification standard. The certification based on ISO 13485 is not directly linked to the specification of the manufactured products. ISO 13485 certification indicates that the processes for designing and manufacturing medical devices are appropriate for providing consistent product quality and safety.
The IAF Multilateral Recognition Arrangement (MLA)
IAF is an organization of accreditation bodies and other interested stakeholders from more than 50 countries. Most accreditation bodies operate under the authority of their own nation’s government and cooperate in the development and maintenance of Multilateral Recognition Arrangements (MLAs).
Signatories to the IAF MLA agree to promote acceptance of accredited certificates issued by all the other IAF MLA signatories within the scope of the MLA. Thus the MLA underpins the recognition of ISO 13485 certificates issued by certification bodies accredited by IAF member accreditation bodies.
Structure of the MLA
Certificates issued by bodies accredited by the IAF MLA Signatories can be relied upon throughout the world because the MLA assures the credibility of the certificate to customers.
The MLA is structured in 5 levels. ISO 13485 fits into these levels as follows:
Includes ISO/IEC 17011 and the IAF Mandatory document (MD8) on the application of ISO/IEC 17011 in Medical Device Quality Management Systems (ISO 13485);
Describes the type of conformity assessment activity e.g. Management Systems. The IAF accreditation system for ISO 13485 will form part of management system activities (no additional documentation required);
Level 3 - ISO/IEC 17021;
The sector specific requirements have been developed by the IAF Technical Committee and are contained in the IAF mandatory document (MD 9) on the application of ISO/IEC 17021 for the Medical Device Quality Management Systems (ISO 13485).
Level 5 - ISO 13485.
Accreditation bodies that are signatories to the IAF MLA may extend their scope of operation to include medical devices if they accredit certification bodies that issue ISO 13485 certificates. They will do this either directly to IAF or through their regional group if the regional group includes ISO 13485 as part of their regional MLA.