03 January 2017
BSI, the business standards company, has become the first certification body to achieve accreditation for the issue of quality management certificates against the requirements of ISO 13485:2016.
To gain accredited status, BSI’s processes were independently reviewed by the Standards Council of Canada (SCC). SCC accredits organizations that certify the management systems of medical device manufacturers. Under the Canadian Medical Devices Conformity Assessment System CMDCAS, only certification bodies accredited by SCC are eligible to certify medical device manufacturers’ management systems.
BSI is now able to issue both SCC and UKAS accredited certificates to the latest edition of ISO 13485, the internationally recognized quality management systems standard for the medical device industry, to its clients.
Existing BSI certification customers have until 28 February 2019 to transition from ISO 13485:2003 and the associated European Standard EN ISO 13485:2012. BSI has developed a suite of materials, services and courses to help make the transition as smooth as possible, details can be found on our transition page: www.bsigroup.com/ISO13485revision.
Gary Slack, Senior VP, Global Healthcare Solutions, BSI said: “ISO 13485 is the world’s leading Medical Device standard, with over 27,000 certificates globally, therefore we’re very proud to achieve accreditation from SCC. We have invested heavily in making sure that we provide our clients with the best service possible to transition early to the standard.”
Further information will be provided via your normal BSI contacts, however, we recommend you start to plan your transition now and contact our planning team to ensure BSI can respond to your timescales.
Medical Device Single Audit Program (MDSAP)
The MDSAP is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements. Five of the RAs (Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW) have been running a three year MDSAP pilot, finishing December 2016. CMDCAS auditing organizations were eligible to apply for authorization under the MDSAP program during the pilot phase. BSI was the first auditing organization authorized during the Pilot Phase. The operational phase of this program is scheduled to begin in January 2017.
Health Canada has announced that as of 1 January 2019, they will terminate their current CMDCAS program and only accept MDSAP certificates. Manufacturers with products on the market in Canada cannot wait until 29 February 2019 to transition to the ISO 13485:2016 certificate. Failure to meet the 1 January 2019 date for transition to a MDSAP certificate may mean your products will not be licensed in Canada.
Schedule your MDSAP transition audits now.
BSI recommends that if you have not been contacted by your BSI Account Manager or BSI directly, please contact us to discuss your transition to MDSAP as soon as possible. For further information on this decision and how it impacts your ISO 13485 certification please visit the page: bsigroup.com/mdsap.