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ISO 13485 specifies requirements for a quality management system for the design and development, production, installation, and servicing of medical devices, and the design, development, and provision of related services. It can also be used to assess the organization's ability to meet customer and regulatory requirements. The quality management system requirements specified in ISO 13485 are complementary to technical requirements for products.
CBs applying for ISO 13485 accreditation must conform to ISO/IEC 17021-1. ISO 13485 is a base standard program in ANAB's fee schedule.
Please refer to the information about the accreditation process at How to Become an ANAB-Accredited Certification Body.
You can view the ISO 13485 application to understand specific requirements but the application process must be completed online via ANAB's EQM database; first-time EQM users must register to create an account.
Accreditation Requirements for Management Systems CBs
ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes (available from ANSI with member discount)
IAF MD 8:2020, Application of ISO/IEC 17011:2017 in the Field of Medical Device Quality Management Systems (ISO 13485) (available from IAF)
IAF MD 9 :2017, Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485) (available from IAF)
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