Recently, two ballots for committee resolutions were held - and approved - to change the scope text and title of ISO/TC 210.
Recently, two ballots for committee resolutions were held - and approved - to change the scope text and title of ISO/TC 210. This post provides background information on the why of those proposals.
Already back in 2018, with the publication of the Strategic Business Plan, it was realized that the scope text could be improved. Not until the May 2021 virtual plenary of ISO/TC 210, a resolution was passed to establish an Ad Hoc group to review the current scope of ISO/TC 210 and determine whether any editorial changes should be proposed to improve clarity and alignment with the current and expected future work program. This review resulted in a proposal to modify the scope of ISO/TC 210, circulated for ballot in November 2021. The ballot passed in December 2021 without comments resulting in changes.
Following the committee approval to modify the scope text for ISO/TC 210, it was noted that there was a slight mismatch between the new scope text, which refers to “products with a health purpose”, and the title of ISO/TC 210, which thus far specifically mentioned “medical devices”.
To resolve the mismatch and avoid confusion, a resolution proposing to modify ISO/TC 210’s title was circulated for ballot in May 2022. The resolution was approved with several comments submitted. The Chair and committee manager reviewed the comments and found no issues substantive enough to modify the ballot proposal, apart from a change of “devices” into “products”. The resulting new title for ISO/TC 210 is: “Quality management and corresponding general aspects for products with a health purpose including medical devices”
With both resolutions approved, and no substantive or unresolvable issues raised, the committee approved scope text and title for ISO/TC 210 have been forwarded in July 2022 to the ISO Central Secretariat to request formal blessing by ISO/TMB, and to implement changes.
The approved scope text, once implemented, allows ISO/TC 210, perhaps jointly with other TCs, to develop deliverables, like on quality management or risk management, for products with similar intended use and similar risk profile as medical devices that are based on processes similar as for medical devices. Clearly, ISO/TC 210’s main focus will not move away from medical devices!