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BS EN ISO 13485:2016

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Medical devices. Quality management systems. Requirements for regulatory purposes
More Information
Publication StatusCurrent
Publication Date29/02/2016
Format (Paperback, Hardback etc)A4
Total Pages70
Brand / PublisherBSI

Official BSI Distributor

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 recognised 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 organisation involved in one or more stages of the life cycle 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 organisations that are required by contract to conform.

What is the relationship 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.


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