BSI achieves accreditation to certify organizations to new ISO 13485:2016 standard

BSI, the business standards company, has become one of the first certification bodies to be granted 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 United Kingdom Accreditation Service (UKAS). BSI is now able to issue 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.

Certification customers have until 28 February 2019 to transition from ISO 13485:2003 and the associated European Standard EN ISO 13485:2012; we recommend you start to plan your transition with urgency.

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 UKAS. We have invested heavily in making sure that we provide our clients with the best service possible to transition early to the standard.”

Medical devices timeline

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 contact us at +6 03 2242 4211 or submit online enquiry here.


Transition Training courses for ISO 13485:2016

We use accelerated learning techniques to make sure you fully understand the new ISO 13485:2016 and we put your learning into context with a blend of classroom teaching, workshops and interactive sessions.





ISO 13485 revision
OHSAS 18001 revision