Skip to content

ISO 13485:2016 and 21 CFR 820 Audit Checklist



What is ISO 13485:2016?

ISO 13485:2016 is an international standard that establishes requirements for a quality management system (QMS) for medical device manufacturers and organizations involved in the design, development, production, installation, and servicing of medical devices. This is established with the intent of creating quality, safety, and effectiveness of medical devices throughout their lifecycle.

What is 21 CFR 820?

The regulation established by the FDA provides a comprehensive framework for medical device manufacturers to ensure the safety, effectiveness, and quality of their products throughout their entire lifecycle. Compliance with 21 CFR 820 is mandatory for all manufacturers, importers, and device companies operating within the United States or exporting medical devices to the U.S. market.

What is included in this ISO 13485 & CFR checklist

Rook Template 13485 and 820 Audit Checklist

The checklist below to assess the quality system requirements for compliance with ISO 13485:2016. This will ensure you meet regulatory requirements to prepare you for an internal audit.

  • A list of all the clauses of 13485
  • A list of all the sections CFR 820
Back To Top