The ISO Technical Committee for medical device management system standards, TC 210, received a waiver from the ISO Technical Management Board (TMB) to deviate from the Annex SL high level structure for its upcoming ISO 13485 revision.
Speaking to Oxebridge, TC 210 Chair Dr. Eamonn Hoxey, confirmed the waiver, saying:
The ongoing revision of ISO 13485 will be based on ISO 9001:2008 structure and not the HLS. As ISO 13485 is based on ISO 9001 and explicitly used for regulatory purposes, it was agreed to not use the HLS until ISO 9001 had transitioned to the new structure.
This was confirmed with a source within the ISO TMB, who indicated that at least one TC had received permission to deviate from the Annex SL mandate because ISO 9001 had not yet adopted it formally.
This does not mean the TMB has begun allowing TCs to deviate permanently, however. In the TC 210 case, the waiver was only allowed because ISO 13485 is based on ISO 9001, and ISO 9001 has not yet adopted the high level structure. Because ISO 13485 is due to be published before ISO 9001, this was deemed as acceptable. It is presumed, therefore, that TC 210 will have to request another waiver once ISO 9001 is updated to align with Annex SL, and sources say it is unlikely that the TMB will grant that waiver. As a result, the ISO 13485 standard would have to be updated again to comply with Annex SL, but that may not happen until it’s next five-year review. This may cause problems as some within the medical device community have expressed concern over the differences in risk management approaches of ISO 13485, which are more closely aligned with traditional product risk management, and the vague “risk based thinking” approach defined by TC 176 for ISO 9001.
The TMB has been inconsistent in clearly stating that a waiver is required, but has recently updated its rules to make it more difficult for TC’s to deviate from its Annex SL demands. Sources within ISO have indicated to Oxebridge that the TMB has not clearly delineated its position to the TCs, increasing frustration.
Annex SL has proven controversial among the ISO Technical Committees, as it forces the TCs to adopt language and content not developed by the consensus process nor their elected delegates, but by the “appointed” 14 members of the ISO TMB. This, Oxebridge argues, deviates from ISO’s rules and the understanding it has with the World Trade Organization that standards will be developed by consensus of ISO member nations, not by any single interest group.
Christopher Paris is the founder and VP Operations of Oxebridge. He has over 35 years’ experience implementing ISO 9001 and AS9100 systems, and helps establish certification and accreditation bodies with the ISO 17000 series. He is a vocal advocate for the development and use of standards from the point of view of actual users. He is the writer and artist of THE AUDITOR comic strip, and is currently writing the DR. CUBA pulp novel series. Visit www.drcuba.world
