ANAB Accreditation for ISO 13485 Medical Devices Quality Systems
ISO 13485 contains the requirements of ISO 9001 plus additional medical device industry requirements. 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.
A CB applying for ISO 13485 accreditation must conform to ISO/IEC 17021 and be accredited or in application for accreditation by ANAB for ISO 9001 or in application with ANAB. 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 in .pdf format 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.
IAF MD 9 :2011, Application of ISO/IEC 17021 in Medical Device Quality Management Systems (ISO 13485) (available from IAF)
For more information, contact ANAB.
Accredited Certification for ISO 13485
Read an article by Grant Ramaley on IAF efforts to promote accredited certification to foster world trade, published by Medical Device and Diagnostic Industry.
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