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 in this page. 

Gain the market confidence you need to reach your goals.

BSI employs over 150 medical equipment experts with experience in all aspects of the product life cycle including research and development, manufacturing, and quality assurance.

Mitigate future risk and manage compliance – especially as your position in the global market shifts. BSI has multilateral agreements with many countries so that our test reports for a wide range of products can be accepted.

What are the benefits of ISO 13485 Medical Devices?

  • Increase access to more markets worldwide with certification
  • Outline how to review and improve processes across your organisation
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical equipment
  • Meet regulatory requirements and customer expectations

Access to Global Markets

By working with BSI, medical device manufacturers are choosing to seamlessly access global in-house experts with regulatory experience in a wide-range of products and technical areas. Our experts have extensive hands-on experience in all aspects of the product life cycle including R&D, manufacturing and quality.

We are an approved "full scope” Notified Body recognised by the European Commission for 17 Directives and also hold recognition by FDA (US), CMDCAS (Canada), JPAL (Japan), ZLG/ZLS (Germany), and (Australia under MRA),Taiwan FDA (under TCP program), and HongKong MDCO (under HKCAB). We offer a results-focused portfolio of products and services for each stage of your certification journey, and we are committed to establishing long-term, proactive relationships with our customers.

What is Medical Device Single Audit Programme?

The Medical Device Single Audit Programme (MDSAP) is an international initiative led by Regulatory Authorities (RA) to implement a programme 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.

Associate Consultant Programme

Get the additional support and advice you need to become certified with our Associate Consultant Programme. We can connect you with over 200 UK members who offer specialist consultancy services independent of BSI. 

Popular Medical Devices training courses

Design and develop medical devices to international quality standards, ensure smooth submission, meet ISO 13485 standards, satisfy customers and keep ahead of all regulatory developments with our medical devices training courses.

Why choose BSI?

We pioneered standards more than 100 years ago and today we are the market leader. We help over 65,000 organisations to stand out from their competitors, ranging from top global brands to ambitious SMEs in 150 countries. As one of the few organisations with a thorough understanding of standards, we do not only assess how well you meet the standards, but also create new standards and offer global training to your teams in using them to enhance performance. Our knowledge can transform your organisation.