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.”

BSI has developed a suite of materials, services and courses to help make the transition as smooth as possible; links to these materials can be found below


ISO 13485 transition resources

BSI is committed to ensuring a smooth transition to ISO 13485:2016, whether you are new to the standard or transitioning from ISO 13485:2003 / EN ISO 13485:2012. 

 

Use our Readiness Review to analyse your progress towards meeting the new requirements of the standard, and to detail how you will achieve this.

 



Updated ISO 13485 training

BSI has a range of courses on ISO 13485, from an introduction course for those new to the standard, to internal and lead auditor courses for those actively involved in the implementation of the standard in their organization.

 

We have recently updated our suite of ISO courses to reflect the requirements of the new standard, including:   

   Introduction to ISO 13485 

   ISO 13485 Clause-by-Clause 

   Implementing ISO 13485 Medical Devices 

   Internal Auditor ISO 13485 Medical Devices 

   Lead Auditor ISO 13485 Medical Devices 



For those familiar with ISO 13485, our transition courses offer focused training on what’s new and what’s changed:
  
   ISO 13485:2016 Transition

   ISO 13485:2016 Auditor Refresher

   ISO 13485:2016 Transition & Auditor Refresher



View all our courses on our training page to find out more