» ISO 13485: 2012

31 May, 2013

The UKAS Approach to Transition of Certification Body Accreditation to the 2012 version of ISO 13485

ISO 13485: 2012 is now in place and will replace the 2003 version

The 2012 standard does not make any changes to the normative requirements of the standard.

The changes include revisions to the foreword plus annexes made to provide greater clarity on applicability & alignment of ISO 13485 clauses with the QMS requirements of the medical device directives, MDD, AIMD & IVDD.

Therefore there is no requirement for transition assessment for UKAS accreditation, accreditation schedules for existing accredited Certification Bodies will be automatically updated to reflect the 2012 standard and, at your next UKAS scheduled assessment, UKAS will check that the 2012 standard has been adopted by the Certification Body.

For further information please contact:

Kate Rolfvondenbaumen: Medical Devices Technical Focus kate.rolfvondenbaumen@ukas.com

Kevin Belson: Technical Manager kevin.belson@ukas.com