Document Control at Suppliers - Control of External Documents

Hi, My company was recently audited and one of ther minor non-conformances raised was in relation to Control of external documents. We are a specifications developer that outsources production, sterilisation and distribution to another company. How do I control the use of most recent documents? i.e. drawings, labeling artwork. How do I confirm removal of obsoloete documents. Any input from how others manage supplier document control would be muchly appreciated!

When we send out controlled copies of our docs, they have a form attached where the external source signs to indicate that they removed the previous copy and replaced it with the current revision. They are then required to fax/email the completed form, which is then filed with the drafts and change control documentation for that revision. The form we give to the external source lays out the required steps to make it as easy as possible for them to follow our document control expectations.

tantan said:

Hi, My company was recently audited and one of ther minor non-conformances raised was in relation to Control of external documents. We are a specifications developer that outsources production, sterilisation and distribution to another company. How do I control the use of most recent documents? i.e. drawings, labeling artwork. How do I confirm removal of obsoloete documents. Any input from how others manage supplier document control would be muchly appreciated!

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I'm not an expert in medical devices or 13485, but if the requirements are akin to those in ISO 9001, "external" refers to documents from sources external to your company, and not to documents you provide to suppliers. This is not to say that control isn't an issue, but if the auditor wrote the NC against control of external documents requirements he's probably in the wrong clause. The question, it seems to me, is about how you evaluate/confirm the document control processes of your suppliers.