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ISO 13485:1996, 1998, 2000, 2003?ISO 13485 and 13488 were first released in 1996 as a list of quality system requirements for medical device manufacturers stepping off from the ISO 9001:1994 well-known standard. Canada, through CSA published their version as CSA ISO 13485/13488 in 1998. The 1998 Canadian version is exactly the same as ISO 13485:1996. CEN, the Committee for European Normalisation, and each of the Standards organisations throughout the 16 EU Member States (ex. DIN in Germany, NSAI in Ireland), harmonised the standard as EN ISO 13485:2000. This is exactly the same as ISO 13485:1996 also. The FDA, who represented the USA on the technical committee TC210, participated in the development of the 1996 standard, and many of the requirements are virtually identical to those in 21 CFR 820, the FDA Quality System Regulation for medical device manufacturers, released that same year. With the release of a revised ISO 9001 standard in 2000, ISO 13485 had to be re-written. TC210, again, including USA representation by the FDA, developed a revision which was released as ISO 13485:2003. While each EU member state's standards organisation as well as Canada's published the revision during the summer of 2003, compliance with the standard is not required for CE Marking in Europe or for Canadian product licensing YET. Several Tier I EU Notified Bodies and CMDCAS (Canada) Registrars have announced that upgrades to the 2003 revision will be required to maintain certification and product licenses for all audits scheduled in the second half of 2005. The revision, structured similar to the ISO 9001:2000 standard, introduces approximately 30 new requirements, several of which must be conducted by Top Management. Don't know much about ISO 13485:2003, and concerned about maintaining product licenses? You're not alone. The CRO Group specialises in providing training, preparing the necessary changes to the documented QMS (Quality Management System), internal auditing, and pre-audits so it won't cost an arm and a leg to find out how close your QMS is to conformity. For more information, please contact us at qs@crogroup.com
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