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

BS EN ISO 13485:2016

Medical devices. Quality management systems. Requirements for regulatory purposes

Status : Current, Work in hand   Published : February 2016



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What is this standard about?

 This is the internationally recognized quality management system (QMS) standard for the medical device industry. It has more than 27,000 accreditations  worldwide. It specifies requirements for a QMS for organizations involved in one or more stages of the lifecycle of a medical device. It provides the basis for ensuring consistent design, development, production, installation and delivery of products that are safe for their intended purpose. 

Who is this standard for?

 It 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.

Why should you use this standard? 

ISO 13485:2016 can be used to test an organization’s ability to meet both customer and regulatory requirements. Certification is not a requirement and organizations can reap the benefits of the standard without being certified. 

Its use shows a commitment to quality, however, and users will 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’s changed since the last update?

 This revision ensures that the standard provides a quality management system that’s kept up with the evolving directives and other international regulatory changes that have occurred since 2003. Some of the key changes 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

You might also be interested in:

PD CEN/TR 17223:2018

Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation 

Standard NumberBS EN ISO 13485:2016
TitleMedical devices. Quality management systems. Requirements for regulatory purposes
StatusCurrent, Work in hand
Publication Date29 February 2016
Normative References(Required to achieve compliance to this standard)EN ISO 9000:2015, ISO 9000:2015
Informative References(Provided for Information)IEC 62366-1, GHTF/SG1/N071:2012, GHTF/SG1/N70:2011, ISO 19011, ISO 10012, ISO 14698, GHTF/SG5/N4:2010, ISO 11607-2, ISO 14644, GHTF/SG1/N055:2009, ISO 11607-1:2006, ISO 9001:2015, ISO 14971:2007
ReplacesBS EN ISO 13485:2012
International RelationshipsEN ISO 13485:2016/AC:2016
Amended ByCorrigendum, January 2017; Corrigendum, March 2016
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 Size2.482 MB

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