30 October 2015
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes, the internationally recognized medical device industry quality management systems (QMS) standard, has been under revision since 2011. A final draft of the standard has now been released incorporating changes made following feedback from users and experts around the world. In accordance with the consensus-based approach, BSI, the UK National Standards Body has participated by providing technical input and commentary.
The standard specifies requirements for a QMS, where an organization needs to demonstrate its medical devices meet applicable regulatory criteria. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. It supports medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. As a harmonized standard* it helps medical device manufacturers achieve compliance with the evolving European Directives and other international regulatory changes that have occurred since the last revision in 2003.
There have been two public consultations, which saw close to 1500 comments, and elicited collaborative input from trade associations, manufacturers, academia and individual experts. The standard is expected to be published in spring 2016. A final draft of the standard has been released and customers have a unique opportunity to see it with ISO 13485 Advanced Access. They will also receive automatic delivery of the final standard as soon as it is available. As there will be no technical changes to the standard, organizations taking advantage of Advanced Access will get a preview of the technical content.
The new ISO 13485 is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device. Some of the key changes include:
- Harmonization of regulatory requirements
- Inclusion of risk management throughout the QMS
- Additional clarity with regard to validation, verification, and design activities
- Strengthening of supplier control processes
- Increased focus regarding feedback mechanisms
- Software for QMS, manufacturing and the medical device
Anne Hayes, Head of Market Development for Governance and Risk at BSI said: “The regulatory landscape for medical devices is a rapidly changing one, and with that comes the evolution of ISO 13485. Today, we have to consider the supply chain and associated risks, so it is necessary to have transparent pathways in place - where all the development stages of a medical device can be observed, and any issues managed correctly. It is about being one step ahead, offering Advanced Access to the standard, is another way to ensure that.”
Existing certification customers will have three years from the date the new edition publishes, 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: https://www.bsigroup.com/en-GB/medical-devices/our-services/ISO-13485-Revision/
This includes the Whitepaper: ISO 13485 - The proposed changes and what they mean, which introduces the proposed updates to ISO 13485, the quality management system standard that complements product specific directives. Register and download this whitepaper.
ISO 13485 Advanced Access: shop.bsigroup.com/iso13485AdvancedAccess
Notes to editors
- * Harmonization status to be determined at a later date
- ISO 13485 is a standalone standard, but is generally harmonized with ISO 9001, its sister standard (although it does not provide conformity with 9001)
- The new edition of ISO 13485 will keep the ISO 9001:2008 clause structure, rather than adopting the High Level Structure introduced by ISO 9001:2015
- Annex B of the new ISO 13485 provides a comparison of content with ISO 9001:2015