The medical regulatory landscape is undergoing its most significant overhaul in years, and with that comes a need to stay up-to-date with the latest regulatory intelligence and how the changes impact your organisation.
As we progress towards the publication of ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes), we interviewed John Howlett, LRQA Medical Devices Technical Manager, for his views on the current status of the revision to ISO 13485.
Q: What is the latest update on the ISO 13485 revision?
John Howlett: The standard is currently being revised and is at Final Draft International Stage (FDIS) - the penultimate stage in the ISO revisions process. The voting process for ISO/FDIS 13485:2016 ended on 29 December 2015 following a positive vote in both the ISO and CEN ballots, and has been submitted for publication.
Global and European stakeholders should take note that the FDIS will be adopted as both an ISO and EN standard, and the process will then commence on harmonising the EN version under the European Medical Device Directives.
Based on external information, we expect ISO 13485:2016 to be published before the end of March 2016.
Q: What are the key changes to the new standard?
John Howlett: There are a significant number of changes and enhancements, the key areas being:
The need for a risk-based approach to the QMS processes taking into account the roles of the organisation;
A greater emphasis on the responsibilities and commitment of top management and to applicable regulatory requirements;
Increased controls over supplier and outsourced activities; and
Risk management is now emphasised throughout the product life cycle.
The risk-based assessment methodology we adopt at LRQA ensures that you conform to the standard. But more than that, we apply themed assessments focusing on your key risks and areas for continual improvement, transforming your management systems from compliance to performance.
Q: How long will companies have to transition to the new standard?
John Howlett: A three-year transition period has been proposed commencing from the date of publication of ISO 13485:2016.
Q: What should manufacturers, particularly those holding dual certification against ISO 9001 and ISO 13485, take note of?
John Howlett: One of the key aspects for manufacturers holding certification against the ISO 9001 and ISO 13485 going forward is the differing formats of the two standards. ISO 9001:2015 follows the Annex SL - the common text and high level structure, while the revised ISO 13485 standard will maintain the ISO Guide 83 format.
Q: Why has the revised ISO 13485 standard not followed the Annex SL structure?
John Howlett: Although the revision of ISO 13485 trails that of ISO 9001, work on revising ISO 13485 actually started in 2010, prior to that of ISO 9001 and other management standards. As a result it was decided to maintain the ISO Guide 83 format for the current revision of ISO 13485.
Q: Do you think the ISO 13485 standard will be aligned with Annex SL in future?
John Howlett: Whilst there is no plan as part of the current revision to align ISO 13485 with Annex SL, it is expected that all future revisions of the standard after ISO 13485:2016 will follow Annex SL given that the format has been adopted for all new and revised ISO management systems standards.
Q: How does ISO 9001:2015 relate to ISO 13485:2016?
John Howlett: Annex B of the revised ISO 13485 standard provides a comparison of content with ISO 9001:2015.
Q: Is it possible for manufacturers to adapt their own management systems to meet the requirements of both ISO 9001:2015 and ISO 13485:2016?
John Howlett: Yes. However, a management system should adopt the process approach in order to be compliant with each or both standards. A company’s processes should therefore be set up and evaluated to meet both standards.
Whilst ISO 13485:2016 does not include requirements specific to other management systems, the standard enables an organisation to align or integrate its own QMS with related management system requirements. An organisation can therefore adapt its existing management systems to establish a QMS that complies with the requirements of ISO 13485:2016.
Q: What steps can manufacturers take in the meantime?
John Howlett: With ISO 13485:2016 expected to be published as an international standard before the end of March 2016, users of the standard can already start developing a transition plan with the help of their Certification Body.
In fact, LRQA recently launched the ISO 13485:2016 Update Workshop, a training course designed to provide manufacturers an overview of the new and changed areas of the standard as well as an opportunity to identify how their own management systems may need to be adapted to ensure a smooth transition.
More such ISO 13485:2016 related training courses and transition solutions will be launched as we move towards the publication of the revised standard, in order to support companies in managing their transition to ISO 13485:2016 effectively.
About John Howlett
John Howlett is widely recognised for his expertise within the medical device industry, having had a long career at BSI where he was the medical directives’ Head of Notified Body for more than 10 years prior to joining LRQA in March 2015. In 2012, John was selected as an expert witness in the UK’s House of Commons Select Committee inquiry into the regulation of medical implants in the EU and UK. John also participated in a wide range of European and UK medical device committees and has been actively involved in the review and implementation of the medical device directives and associated guidance documents.
About ISO 13485
ISO 13485 is the international standard that defines quality management system requirements for organisations that design and develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices. It is derived from the same basic principles as ISO 9001, but places additional emphasis on areas such as documentation, the work environment, risk management, design control and medical device reporting to meet regulatory requirements.
Through our extensive range of training and assessment services, LR is helping organisations worldwide transition to the new and revised ISO standards.
Please note that as of January 2018, we have moved to the Lloyd's Register brand and retired the LRQA name.