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.

What are the implications for ISO 13485 certificate holders?

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.

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.”

What do I need to do now?
Further information will be provided via your normal BSI contacts, however, we recommend you start to plan your transition with urgency and contact our planning team to ensure BSI can respond to your timescales.