ANAB Accreditation for ISO 13485 Medical Devices Quality
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.
Requirements for Management Systems CBs
ANAB Accreditation Rule 35
IAF MD 9 :2011, Application of ISO/IEC 17021 in Medical Device
Quality Management Systems (ISO 13485) (available from IAF)
ISO 13485:2003 Medical devices - Quality management systems
- Requirements regulatory purposes (available from ASQ and ANSI,
both with member discounts)
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.