Conclusion of the ISO 13485 Transition Period

Bulletin date:
Bulletin number:
2019-01

Action required

All Management Systems Certification Bodies must cease offering certification to ISO 13485:2003 under their SCC accreditation.

 

Affected customers

Accredited management systems certification bodies operating in medical device management systems.

 

Background

Effective March 1st, 2019, the transition period for ISO 13485:2016 will have ended. As such, starting March 1st, 2019, any certificates issued to the previous version of the standard (ISO 13485:2003) under the certification body’s SCC accreditation will no longer be valid, and shall be withdrawn if not already done.

 

New requirements

SCC confirmed successful transition of its customers; therefore all SCC customers are accredited for certification to ISO 13485:2016.  As a result and with the end of the transition period, the following amendment will be made to all applicable Management System Accreditation Program scopes of accreditation:

  • All references to ISO 13485:2003 will be removed.

     

Deadline

n/a

 

Questions?

Please contact Elias Rafoul, Vice President, Accreditation Services, at elias.rafoul@scc.ca or +1 613 238 3222 for more information.