Journey to a new Frontier – The ISO13485 Revision Process, Future Implementation
It’s Ready for Publication!
Finally, the long-awaited revision of ISO13485 is approved for publication
And as I travel around, met people and chatted about the possible impact to the medical device industry and specifically to any organisation’s quality management system, it became apparent that perhaps the process of standards development in ISO and the efforts in which hard-working people within the TC210 members is briefly explained, to have more medical device industry members, regulators and organisations understand this process at a high level.
What is the TC210?
The ISO TC210 is the Technical Committee responsible for standardization of requirements and guidance in the field of quality management and corresponding general aspects for medical devices, as well as standards for small bore connectors. There are seven groups (including a Joint Working Group) as shown in the graphic below
TC210 WG1 consists of members from country regulators, industry consultants, quality/regulatory representatives from medical device companies, from certification companies, and members from standards organisations. There is a fair representation from the industry, especially from the consultants who lend their expertise from their experience with companies large and small and complex.
The Revision’s Journey
The process started in 2012, as it took some years before the justification to revise the standard came through, and this timeline charts a 4-year journey; from the moment the New Work Item Proposal (NWIP) is raised, until the new ISO13485 revision’s expected publication.
ISO follows a structured process for ISO standards development and document control and they use stage codes as a way of tracking progress (see image below)
Working Group 1 gathered and the process starts with the new work item proposal, the design specifications (putting it simply, the scope and what the revision of the standard was meant to achieve), and then the working drafts (WD) were created. These working drafts are then sent to the Participating and Observing countries for the TC210 (P and O members).* for their comments. The current P and O members are listed below:
· Hong Kong (ITCHKSAR) (Correspondent member)
* P members are allowed to vote, but O members cannot. All members are expected to participate on the review and commenting of the standard. Stricter criteria will be applied in future for P members in terms of their participation in their TC’s standards development. The Standard is approved if it secures more than 75% positive votes.
Comments Resolution, Voting
The Working group was divided up into smaller groups address the various clauses in the standard, and including the Annex Z and then compiled to WD. We went through the process of WD1, WD2, and the CD then to the DIS1, DIS2 and to the FDIS, handling several hundred (!) comments in each round. Multiply that with some instances where it takes a long time to even deliberate a single phrase, a single word! It may sound odd to some, but I’ve learnt to appreciate the level of detail in assessing the impact of the choice of words to ensure consistency, ease of translation and clarity in meaning.
This site in ISO best describes the general process of any standards development and thus the terms WD, CD, DIS, FDIS are explained.
One interesting point noted was that the number of comments actually increased (at one point, reaching 800+) as we progressed to the FDIS! To maintain transparency, the working group had to address each and every comment with justifications of why it is accepted or rejected.
Upon resolving all these comments by the members, all it takes is for the FDIS to be subjected to approved by voting, and members had to weigh the pros and cons before casting their votes.
Transitioning Along to the New Standard
Upon publication, the 2003 version will be withdrawn in 3 years, and organisations have up to 2 years to transition to the 2016 version. That means, by 2018, organisations can no longer be certified to the 2003 version.
What is the impact?
The changes between the versions, although not revolutionary, are significant, and would take some time for medical device organisations to understand, revise, implement and verify these changes. A lack of a proper transition leads to much time, effort and money wasted in remediation efforts and re-auditing, not to mention potential delays in shipments to customers.
What’s more, there are about 28,000 (!) ISO3485 certificates around the world* – No trivial matter!
*Note: number of ISO13485 certificates in China more than doubled from 2013 to 2014. Click here to request a copy of all the results.
It Takes Time, Effort and Money to Transition
You’d need time and effort and money to…
– understand the textual difference between old and new
– understand what these changes mean to your organisation
– assess what actually needs to be done
– Apply these changes to the quality management system
– Implement these changes
o Revising documents
o Approvals for these changed documents
o Verification and validation, as needed
o Effectiveness of training
o Audit and Management review to verify these changes are done
– Take corrective actions, if needed
– Re-audit for compliance
– Go for re-certification
Here’s a PCDA that helps you focus on the main tasks of the transition
What’s Next for the Workgroup?
Moving forward, there’s more work for the workgroup to do. Members of WG1 have come together to work on the proposed ISO13485 Handbook, which aims to provide a more aligned guidance towards the interpretation of the standard, in perhaps a friendlier, conversational style as compared to the existing ISO14959 (which will eventually be withdrawn). Hope that helps to make reading and understanding the interpretation of the Standard easier
The group also works on a comparison between ISO13485:2016 with ISO9001:2015. Such comparison is greatly needed by many companies producing medical devices and non-medical devices, as they seek to have an efficient quality management system that complies to both standards to meet customer and regulatory requirements.
The ISO13485 Standard continues to be used by the medical industry, and its regulators. Now with its scope clarified to include all medical device organisations, I hope this revision truly provides guidance for the quality management system requirements for the medical device supply chain. Amongst the significant changes, the Standard now provides a viable value proposition for it to be utilized by regulatory agencies for their regulatory needs such as quality management system requirements for importers and distributors (also termed as Good Distribution Practice or Good Supply Practice). Most countries still import most of their medical devices, so it makes sense to have appropriate regulation to this part of the medical device supply chain.
One observation I had picked up was the varying levels of engagement with the representative standards bodies with their country’s medical device industry and regulatory agencies. Some were great, some needs improvement. Perhaps the potential for a much more engaged revision process presents an opportunity for the industry and especially the regulatory agency to be actively involved in standards development, together with the standards bodies. And just perhaps, we may have less variance between regulated countries for quality management system requirements, contributing towards a more harmonised approach to regulating medical devices.
I feel honoured and fortunate to work with members in WG1, through representing the 26 member economies in the Asia Harmonisation Working Party (AHWP) and contributing to ISO13485’s development. The workgroup had learnt much from each other – from practical implementation, to ease of transposition into regulatory requirements, from clarity in wording/phrasing, to ease of translation to foreign languages. It was truly an international group of experts, amidst all the friendly bantering and striving towards consensus – one fun ride indeed. On top of that all, we formed friendships, and I’m looking forward to continuing this journey together in the development of the ISO13485 Handbook.