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ISO 13485:2016 Transition Plans

25 July 2016
Organizations currently certified to ISO 13485:2003 will have three years to transition their QMS. 

Since the issuance of the revised ISO 13485:2016 QMS requirements for medical devices in February 2016 little has been received from our oversight body on the planned transitional process.

We are pleased to confirm that UKAS have now released a ‘Heads Up’ communication on the formal transitional process for certification bodies to follow as we shift focus to the new standard.

1. Organizations currently certified to ISO 13485:2003 will have three years to transition their QMS certification - all ISO 13485:2003 certificates will expire in February 2019 unless transitioned.

2. Once the UKAS process has been defined certification bodies will be able to apply for the scope extension and go through the Transition Accreditation process themselves.

3. ISO 13485:2016 certificates will be issued by NQA in line with these requirements.

4. A majority of organizations will be expected to transition during their normal Re-Assessment activities as the preferred route, but methods for transitioning during normal surveillance visits or at stand-alone special visits also exist.

5. NQA is already fully engaged in its transitional process despite the late involvement of our oversight, we expect to be one of the first certification bodies to achieve recognition and lead the industry in this important revision.

6. In preparation for this transition we have already developed auditor training and education focused at the important changes in the standard.

‚ÄčOrganizations not certified by NQA, but wishing to benefit from our transition programme may transfer their current ISO 13485:2003 registration to NQA by contacting us.