Buy & Download
ISO 13485:2016 Standard PDF

& Other Related Standards

Looking for the text of ISO 13485:2016?

You will need to purchase a copy of the standard to reach certification (sometimes multiple standards are required). Due to copyright restrictions, we are not able to include these with our products. So, we have partnered with Accuris, an authorized seller of ISO Standards. We have sorted each standard into Needed, Recommended, and Additional Related Standards.  Each has a link to purchase through Accuris.

Needed for ISO 13485 Certification:

Graphic of the ISO 13485:2016 Quality Management System Standard
ISO 13485:2016 –Medical devices – Quality management systems – Requirements for regulatory purposes

ISO 14971:2019– Medical devices – Application of risk management to medical devices

Additional Related Standards:

ISO 9001 Family
  • ISO 9000:2015 – Quality Management Systems – Fundamentals and Vocabulary
  • ISO 9001:2015 – Quality Management Systems – Requirements
  • ISO 9002:2016 – Guidelines for the application of ISO 9001:2015
  • ISO 9004:2018 – Quality Management – Quality of an organization – Guidance to achieve sustained success
Medical Device Software
  • IEC 62304 Ed. 1.1 b:2015 – Medical device software – Software life cycle processes – Consolidated Edition
  • IEC/TR 80002-1 2009 – Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software
  • ISO/TR 80002-2:2017 – Medical device software – Part 2: Validation of software for medical device quality systems
  • ISO 31000:2018 – Risk Management Guidelines
A note from Standards Stores:
These standards are sold by the Accuris website, a reseller of ISO Standards that includes ISO, SAE, IATF, and other standards. Many standards are available to download in pdf format. Purchase transactions are conducted on Accuris’ secure site and are not combined with a purchase from 13485Store.
ISO standards cost money to develop, publish and distribute. They are not free. The current system whereby users are requested to pay for the standards they use, not only sustains the development process but also, ensures that the balance of independent vs. government and private vs. public interests can be maintained.

MAKE ISO 13485 CERTIFICATION SIMPLE AND FOOLPROOF!


Our All-in-One Certification Package is a proven, efficient system. It gives you all you need to prepare for registration – in one simple to use package.

Customer Review:

"I have just passed my ISO Audit with zero non-conformances for the second year in a row using your ISO products to write my entire QMS. Thank you for producing documents of this quality"

Bettye Patrick

Buy the Standard

13485 Store Logo ISO 13485