BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes

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BS EN ISO 13485:2016

Medical devices. Quality management systems. Requirements for regulatory purposes

Status : Current   Published : February 2016



ISO 13485:2016 is the internationally recognized quality management system standard for the medical device industry, with more than 27,000 accreditations worldwide. 

What is ISO 13485:2016?

ISO 13485:2016 specifies the requirements for a quality management system  for  organizations involved in one or more stages of the life cycle of a medical device. It provides the basis for ensuring the consistent design, development, production, installation, and delivery of products that are safe for their intended purpose. 

ISO 13485:2016 can be used by internal and external parties, including certification bodies, to test an organization’s ability to meet both customer and regulatory requirements. However, certification is not a requirement of ISO 13485, and organizations can reap the benefits of the standard without being certified. 

Why should you use ISO 13485:2016?

You should use ISO 13485:2016 to show that you have commitment to quality through an internationally recognized standard.   

By using ISO 13485:2016 you’ll be able to:

  • Demonstrate compliance with regulatory and legal requirements
  • Ensure the establishment of quality management system practices that consistently yield safe and effective medical devices
  • Manage risk effectively
  • Improve processes and efficiencies
  • Gain a competitive advantage

What has changed since the previous edition?

Some of the key changes on ISO 13485 from its previous edition include:

  • Harmonization of regulatory requirements
  • Inclusion of risk management throughout the quality management system
  • Additional clarity with regard to validation, verification and design activities
  • Strengthening of supplier control processes
  • Increased focus regarding feedback mechanisms
  • Harmonization of the requirements for software validation for different software applications

This revision ensures that the standard provides a good quality management system for the evolving directives and other international regulatory changes that have occurred since 2003.

Who should use ISO 13485:2016?

ISO 13485:2016 can be used by any organization involved in one or more stages of the lifecycle of a medical device, including:

  • Design and development
  • Production
  • Storage and distribution
  • Installation or servicing
  • Final decommissioning
  • Design, development or provision of associated activities (such as technical support)

In addition, the standard can be used by other internal and external parties, such as certification bodies, to help them with their certification processes, or by supply chain organizations that are required by contract to conform.

What is the relation between ISO 13485:2016 and ISO 9001:2008?

ISO 13485 is a standalone standard, but it is based on and follows the format of ISO 9001. This edition follows the format of ISO 9001:2008, which has been superseded by ISO 9001:2015. This means the edition doesn’t adopt the high level structure introduced by ISO 9001:2015. For convenience of users, Annex B of ISO 13485:2016 provides a comparison of content between ISO 13485:2016 and ISO 9001:2015. 

How long do I have to implement the new ISO 13485:2016?

You’ll have 3 years from the publication date to comply with the new ISO 13485:2016. If you want to ensure continuing compliance and certification to ISO 13485, you will need to update your quality management system for compliance with the new edition. To ensure that you develop accurate transition plans, make sure you have sight of ISO 13485:2016 as soon as possible.

Standard NumberBS EN ISO 13485:2016
TitleMedical devices. Quality management systems. Requirements for regulatory purposes
Publication Date29 February 2016
Cross ReferencesISO 9000:2015, EN ISO 9000:2015, ISO 9001:2015, ISO 10012, ISO 11607-1:2006, ISO 11607-2, ISO 14644, ISO 14698, ISO 14971:2007, ISO 19011, IEC 62366-1, GHTF/SG1/N055:2009, GHTF/SG5/N4:2010, GHTF/SG1/N70:2011, GHTF/SG1/N071:2012, 90/385/EEC, 93/42/EEC, 98/79/EC
Amended ByCorrigendum, January 2017
DescriptorsAcceptance (approval), Quality assurance systems, Medical instruments, Medical technology, Medical equipment, Quality management, Management
Title in FrenchDispositifs médicaux. Systèmes de management de la qualité. Exigences à des fins réglementaires
Title in GermanMedizinprodukte. Qualitätsmanagementsysteme. Anforderungen für regulatorische Zwecke
ISBN978 0 580 96770 2
File Size1.137 MB

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