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ISO 13485:2016 has been published

The world’s most popular standard for medical device quality management has been revised for the first time since 2003 and was published in March of 2016. The new version of the internationally recognized quality management system for medical devices offers greater clarity of the requirements and enhanced compatibility with the latest regulatory requirements. The standard provides the framework to realize requirements of a medical devices quality management system and seeks to address the entire lifecycle of a medical device.

With a continued emphasis on risk management, the 2016 version reflects greater alignment with regulatory requirements including the US FDA 21 CFR Part 820, the Japanese MHLW Ministerial Ordinance No. 169: 2004, and the conformity assessment requirements of the European medical device legislation. The new version has the flexibility and incorporates developments of regulatory requirements for QMS in other jurisdictions. It maintains the requirements compatibility with ISO 9001:2008 and doesn’t follow the high level structure of ISO 9001:2015.

Purchase a copy of ISO 13485:2016 and begin planning for your transition.

Highlights of the key changes to ISO 13485 include:

The scope statement is revised to reinforce its focus on meeting customer and applicable regulatory requirements and not only product requirements. This is applicable in one or more stages of the life cycle of the products including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.

  • Greater flexibility (Sections 6, 7 or 8 may be excluded with adequate justification)
  • Enhanced compatibility with the latest global regulatory requirements
  • Addition of risk management and risk-based thinking to processes as well as product life cycles
  • Further requirements on corrective and preventive actions
  • Expanded requirements surrounding record keeping, specifically with regard to supplier selection and validation
  • Heightened requirements concerning product realization and mechanisms utilized to capture feedback
  • Two annexes are added; Annex A, compares the content between ISO 13485:2003 and ISO 13485:2016 and Annex B, illustrates the direct and indirect correspondence between ISO 13485:2016 and ISO 9001:2015
  • The bibliography lists resourceful implementation guidelines that will help implementing the new requirements of ISO 13485:2016

Proposed Transition Plan

The Draft White Paper – ISO Transition Planning Guidance for ISO13485:2016 published by WG 1 N 233 proposed a co-existence phase the availability of accredited certification to ISO 13485:2003 and ISO 13485:2016. This phase is supposed to last for three years, during which time users will have to update their quality management systems to meet the requirements of ISO 13485:2016 to an accredited certificate. For organizations that are currently certified to ISO 13485:2003 it is recommended to schedule an upgrade audit at a convenient time within the following transition period (see Fig 1).

  • Two years after the publication of ISO 13485:2016, March 1st 2018, all accredited certifications issued (new certifications or re-certifications) will be to ISO 13485:2016.
  • Three years after publication by ISO of ISO 13485:2016, March 1st 2019, any existing certification issued to ISO 13485:2003 will not be valid.

FIG 1 : Illustration of the Draft White Paper – ISO Transition Planning Guidance for ISO13485:2016 published by WG 1 N 233 – November 18th 2015.

Sector Specific Scheme Requirements: ISO 13485
Sector Specific Scheme Requirements: MDSAP


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