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ISO 13485 Update and Transition Requirements

This bulletin is applicable to certification bodies accredited to ISO/IEC 17021 (or ISO/IEC 17021-1) for certification to ISO 13485.

You will be aware that ISO 13485: 2016 – Medical devices — Quality management systems —Requirements for regulatory purposes – was published in March 2016. IAF Resolution 2015/13 allocates a 3 year transition period and the UKAS process for transition is aimed to ensure that CBs have full opportunity to meet this deadline. Thus from 31 March 2019 all accredited certifications to ISO 13485:2012 will cease to be valid. IAF has also stated that 2 years from publication all new certifications and recertifications issued must be to ISO 13485: 2016.

In order to ensure CBs have time to transition their existing certified customers, UKAS is intending to carry out transition assessments to each accredited CB at the next scheduled head office visit, however if an individual CB considers that they will not be ready in time for this they should contact their Assessment Manager so that arrangements can be made to carry out the assessment later, at a future scheduled head office visit or, by special arrangement, additional visits can be arranged depending upon resource availability, please note that additional visits will be subject to an additional charge.

The transition visits will review the competence and readiness of the CB to deliver accredited certification to the new standard as well as ensuring management systems have been updated to reflect the updated requirements.

At the same time as the ISO 13485 transitions, UKAS will review ongoing implementation of IAF MD8 and IAF MD 9 for all ISO 13485 assessment activity. CBs should be aware that this may result in additional assessments for critical locations delivering ISO 13485 certification going forward. This is currently being reviewed and further information will be provided by your Assessment Managers.

Additional time may be required to compete this transition assessment, this will depend upon the circumstances of each CB and is subject to contract review, but it is anticipated that approximately 0.5 days document review and 0.5 days additional site time may be required. CBs are asked to submit a scope extension application, using the AC1 application form, together with documentation showing the CB’s gap analysis and implementation plan for the new standard and guidance, failure to receive this by 2 months prior to the UKAS visit may result in delays to transition.

If you have any queries regarding this update please raise them through your Assessment Manager or contact Kevin Belson – UKAS Technical Manager – [email protected]