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Infographic: What’s new in the 2016 revision of ISO 13485


To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article:
ISO 9001 vs. ISO 13485.


The new 2016 revision of ISO 13485, the leading international standard for medical devices, is finally in front of us. Now we can see exactly what has changed and what needs to be done to achieve compliance with the new version.


The new version of ISO 13485 is aligned with ISO 9001:2008, which may pose challenges for organizations that need to comply with both ISO 9001 (for which the 2015 version complies with the High Level Structure) and ISO 13845.

Transition period

Companies certified against the 2003 revision of ISO 13485 must transition to the new version by March of 2019.


Both versions have the same number of clauses; however, the new version requires additional documents and allows exclusions from clauses 6, 7, and 8.


There are some new requirements, but the most significant are the incorporation of risk-based approaches in the context of the safety and performance of the medical device, and in meeting regulatory requirements and harmonization of the requirements for software validation for different software applications in different clauses of the standard.

Similarities and differences

Since ISO 13485:2016 doesn’t follow Annex SL, it kept most of the requirements from the previous version, so the transition wouldn’t be too dramatic. However, it brings changes in the following areas:

  • application of risk-based thinking to QMS processes outside of product realization
  • evaluations related to changes in regulatory requirements during management reviews
  • assuring that training is effective in achieving competency of personnel to perform their functions
  • requirements related to design transfer and design records
  • design verification, and validation of process and medical device software
  • requirements for the protection of confidential health information
  • clarification and additional requirements focused on complaint handling (requirements for documentation of complaint handling procedures, timely handling of complaints, and compliance with regulatory requirements)
  • planning requirements for corrective and preventive actions

What does the 2016 revision brings to the QMS?

ISO 13485:2016 will bring to your QMS:

  • alignment of global regulatory requirements
  • inclusion of risk management and risk-based decision making throughout the Quality Management System
  • additional requirements and clarity with regard to validation, verification, and design activities
  • strengthening of supplier control processes
  • increased focus regarding feedback mechanisms
  • more explicit requirements for software validation for different applications

Click here to download a free white paper Clause by clause explanation of ISO 13485 to see the requirements of the new standard.

Advisera Strahinja Stojanovic
Strahinja Stojanovic

Strahinja Stojanovic is certified as a lead auditor for the ISO 13485, ISO 9001, ISO 14001, and OHSAS 18001 standards by RABQSA. He participated in the implementation of these standards in more than 100 SMEs, through the creation of documentation and performing in-house training for maintaining management systems, internal audits, and management reviews.