What is ISO 13485 2009?
Medical devices – Quality management systems – Requirements for regulatory purposes –
Technical Corrigendum 1 to ISO 13485:2003 was prepared by the ISO/TC 210 technical committee and published on January 8, 2009. It is a very brief document where the standard ISO 13485:2003 is aligned with ISO 9001:2000 and ISO 9001 is replaced with ISO 9001:2000 in pages v and vi at sub-clauses 0.3 and 0.4; in page 1 at sub-clause 1.1: and in page 25 at first paragraph of Annex B.
Since the document was published after the 2008 release of ISO 9001 and still makes reference to the 2000 release of ISO 9001 it follows that a new corrigendum will be published in the future to align ISO 13485:2003 with ISO 9001:2008. In the meantime and since no new requirements were introduced with ISO 9001:2008, corrigendum 1 remains valid.
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