ISO 13485:2003 Quality Policy Controlled with a Revision date and number?

Should the Quality Policy be controlled with a Revision date and number?????

Thanks
Lisa

If it is a standalone document, then yes. It is a required document and must be controlled.

Many companies will document their policy statement in the quality manual. If so, the controls for the manual also control the policy, so the policy doesn't need its own identifier and revision.

Thanks, that is what I thought as well.

Lisa

Quality Policy controlled with revision date & number

Is it something that ISO should emphsize in the next draft?

I wouldn't think so myself. I did read in the 14385 that it should be controlled. But if it is in the QM then it is controlled.

amanbhai said:

Is it something that ISO should emphsize in the next draft?

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4.2.3 says "Documents required by the quality management system shall be controlled." I don't think they could emphasize it much more than that.