This year, I have been participating in the revision of three standards of differing size, scope, and extent of use: ISO 9001, the generic standard for quality management systems to which over one million companies worldwide are certified; ISO 13485, the quality management system standard for the medical devices industry for which there are around 40,000 registered organizations; and EN 556-2, the European standard defining the requirements to label an aseptically-processed medical device as ‘sterile.’ These revisions have each involved several meetings and a lot of review, comment preparation and review of comments, and made me think about how we could make the process more effective without losing the essential element of development of consensus.
The contrast between the ways that these standards have been revised has been significant because the ISO 9001 revision has had more than 100 experts at each meeting and thousands of comments submitted at each stage, ISO 13485 has had 50-60 experts at meetings and hundreds of comments, whereas EN 556-2 had less than ten experts and about 30 comments. For ISO 9001 and ISO 13485, because of the number of comments and participants, some of the review of comments has been conducted in subgroups and then the conclusions reviewed again by the whole group. In contrast, for EN 556-2, most of the revision work was completed virtually with just a half day, face-to-face meeting.
Two of these projects that have been on quality management systems, and I wonder why the standards process doesn’t mirror the principles of quality management systems in design and development. If we employed a consensus process to identify design inputs for the standard, then a much smaller group with expertise in standards writing could develop the content, which could be subject to formal design reviews with peers and independent reviewers, and refined. The proposed output could be verified against the design inputs, and the whole package subject to design validation to confirm that it met user requirements.
This kind of approach could be undertaken within the current standards procedures, but potentially could be operated with shorter timescales.
Eamonn Hoxey is vice president of market quality for medical devices and diagnostics at Johnson & Johnson. He serves as treasurer/secretary on the AAMI Board of Directors.