ISO 13485:2016 Certification

ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for the design and manufacture of medical devices. The standard focuses on the importance of the lifecycle of a medical device, including its design, development, production, and storage. The standard requires organizations to demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

  • Planning the quality system
  • Meeting regulatory requirements
  • Implementing design controls
  • Documents, records, and training
  • Management processes
  • The Certification audit
ISO 13485 certification is performed by external certification bodies. The ISO organization itself does not issue certificates. The harmonized EN edition of ISO 13485:2016 is identical word-for-word with the international edition. However, it contains three additional annexes identifying where compliance with the Standard does not adequately address requirements in EU Directives.