To SCC Management System Accreditation Program Customers accredited to certify to ISO 13485 and/or ISO 13485 under CMDCAS.
SCC is announcing to its customers the publication by ISO of the following standard:
ISO 13485:2016 Medical Devices – Quality management systems – Requirements for regulatory purposes.
In conjunction with the publication of this revision of the standard, SCC is mandating that its accredited customers transition their certification programs to ISO 13485:2016 and to ISO 13485:2016 under CMDCAS over the next three years so that full implementation to the revised standard is achieved by 2019-03-01. The International Accreditation Forum (IAF) in its resolution no. 2015–13 has determined this timeline for the transition. Consequently, certificates issued by certification bodies (CBs) to ISO 13485:2003 and to ISO 13485:2003 under CMDCAS will cease to be valid on 2019-03-01; moreover, during the transition period, the CBs shall not issue certificates with a validity date (expiry date) beyond 2019-03-01.
CBs are required to submit a written transition plan to SCC, which shall include, but is not limited to, the following items:
- high-level description of CB’s requirements to be met by their applicant and certified clients;
- mechanisms and timelines for transition of their clients to the revised ISO 13485:2016;
- plans for training auditors to the revised ISO 13485 standard (Note: evidence demonstrating successful training of at least several auditors must also be provided);
- the date after which applications for certification to ISO 13485:2003 or to ISO 13485:2003 under CMDCAS are no longer accepted by the CB;
- an outline of provisions in the case of unsuccessful transition by their clients.
In order for a CB to successfully transition, a witness audit is not required. However, once the CB has successfully transitioned, only witness audits to ISO 13485:2016 and to ISO 13485:2016 under CMDCAS shall be accepted.
With the publication of this bulletin, SCC will start accepting transition plans. A CB may submit its transition plan as soon as it is ready or before the next planned head office assessment. SCC will be evaluating transition plans through a desk review/assessment for which SCC fees apply. Once SCC approves the transition plan, the accreditation scope will be updated to include ISO 13485:2016 and/or ISO 13485:2016 under CMDCAS and posted on SCC’s website. This indicates that the CB can start issuing certificates under SCC accreditation to ISO 13485:2016 and to ISO 13485:2016 under CMDCAS. SCC will continue to monitor the effectiveness of these transitions over the course of planned SCC assessments. SCC encourages that accredited CBs start developing their transition plans now and advise their respective account manager when they would like to have their transition plan assessed.
CBs are reminded that their SCC accreditation scope for certification to ISO 13485:2003 and to ISO 13485:2003 under CMDCAS will cease to be valid on 2019-03-01.
For further details about the assessment activities in relation to your transition to ISO 13485:2016 and to ISO 13485:2016 under CMDCAS, please communicate with your account manager.
If you have any questions about this policy, please contact Rassoulou Diallo, Manager, Technical Services at firstname.lastname@example.org or +1 613 238 3222 ext. 437.