The end of ISO 13485 transition | New requirements

Scenario

BSI Policy

Scenario 1: Manufacturers who have completed a transition assessment prior to 28 February 2019 with a recommendation to transition but have not received their certificate.

Note: Major non-conformities must be closed out before a positive recommendation can be made.

Transition assessments conducted before 28 February 2019 allow for the re-instatement of certificates up until 31 August 2019. The visit cycle will return to the natural pre-transition cycle/expiry and the same certificate number.

Customers should use the recommendation contained within their assessment report as evidence of a positive recommendation until they have their certificate.

A gap in certification is created but your certificate will be annotated to demonstrate that you had undertaken your assessment before the expiry date.

Scenario 2: Manufacturers who do not complete a transition assessment prior to 28 February 2019, but have a transition assessment booked before 1 May 2019.

As long as this visit is delivered and a certificate issued before 31 August 2019, the visit cycle will return to the natural pre-transition cycle/expiry and the same certificate number.

A gap in certification is created but your certificate when issued after successful transition will be annotated to identify when the successful audit took place.

Scenario 3: Manufacturers who do not complete a transition assessment prior to 28 February 2019, and do NOT have a transition assessment already booked before 1 May 2019.

The certificate will expire and should you wish to maintain certification you would then need to re-apply and be quoted by a member of the commercial team. This would result in a new certificate number and new visit cycle schedule.