Medical Devices – Transition to 2016 version of ISO 13485

The standards developed by bodies such as the British Standards Institute (BSI) and the International Standards Organisation (ISO), are subject to review about every 5 years.

Accreditation Bodies (for example, UKAS) publish guidelines on making the transition to the new version of the standard to assist Certification Bodies (and their certificated customers) on managing that transition including through the audit process.

The period allowed to make the transition is usually about three years because the Certification Body will need to review and amend its own policies, procedures and guidelines and auditors will need to undertake training so that audits can be completed under the new version of the standard.

Summary of actions required with regard to the transition from ISO 13485:2012 to ISO 13485 : 2016

ISO 13485:2016 incorporates some requirements changes and so a company should review its management system and re-format or expand its infrastructure and resources in order to meet the requirements of the new standard.

Actions required will typically include:

  • Completion of a gap analysis by customers to identify elements to be addressed to meet the requirements of the new standard.
  • Development of an implementation plan.
  • Identification of training needs and provision of training relevant to address such needs.
  • Update of existing systems to meet revised requirements and verify effectiveness.
  • Liaison with external resources in the certification chain to synchronise transition arrangements.

QAICL has undertaken a gap analysis of ISO 13485:2012 vs ISO 13485:2016 and its systems were updated and new audit documentation issued so that audits to the new standard can now be undertaken.

The management, staff and auditors of QAICL have undertaken a programme of training to the new standard which has been rolled out across the company. This should coincide with similar arrangements taken by most customers in order that all audit resources may be fully in place well before the due date of transition at 31 March 2019.

As the cut-off date is 31 March 2019 for transition, this is also the final date that a certificate awarded under ISO 13485:2012 will be issued to. As such, any clients wishing to maintain a full year certificate must have their transition audit “Certification Decision” made on or prior to 1 April 2018.

QAICL Auditors are now reviewing customers’ transition arrangements as part of the surveillance and re-certification process where requested by customers. This will become mandatory as time progresses and before the last cut-off date for transition of 31 March 2019.

In addition to the review of the customer transition arrangements mentioned above, should a client wish to receive a gap analysis audit to determine readiness for transition to the new standard prior to the surveillance and re-certification processes, QAICL can provide this in addition to the regular auditing routine and client companies should apply via the enquiry form on the QAICL website or via email to

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