NQA’s Operations Director, Jim Gracie answers questions about the ISO 13485 revision…..

Q: When was ISO 13485 revised?

A: In 2003 the latest version of ISO 13485 was published for use by companies who design and/or manufacture medical devices. It is typically used by companies who supply the medical devices industry or are active within it. This standard is a progression of earlier versions of ISO 13485, but where as these were essentially bolt-ons to ISO 9001/2:1994, the 2003 version is based on ISO 9001:2000, but is stand alone.

Q: What does ISO 13485 have that ISO 9001 doesn’t?

A: As it specifically concerns the medical devices sector, there are elements which have been extended to encompass controls which are relevant for medical devices. For example: an expansion of the requirements for the ‘work environment’ (paticularly cleanliness); design of the product, (particularly where the product is ‘approved’ for use by regulatory authorities); sterilisation; identification; and procedures for recall of product. Thus ISO 13485 is more focused on the design and manufacture of products for a particular market than ISO9001, which is more generic and can be applied to any sector.

Q: Do I need ISO 9001 to gain certification to ISO 13485?

A: No, certification can be solely against the revised standard’s requirements. Already having ISO 9001, however, would be a helpful start as the management system required would be very similar.

Q: What about the audit itself?

A: Typically, an audit against the requirements of ISO 13485 would be very similar to that for ISO 9001. The assessors would, however, be specially qualified to perform ISO 13485 audits and the duration would be slightly longer. However the certification regime would be the same - an initial audit would take place followed by surveillance of the management system.

(Taken from NQA Reporter, Winter 2005/6)

JPD offers In-company training on ISO 13485, for more information please contact one of our friendly Training Advisors on 01565 724200

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