Library / Control of Document Changes

Control of Document Changes

SOP · ISO 13485 4.2.4 · Owner Quality lead · v3 in review

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Comparing v2 and v3
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3. Approval

Changes are reviewed by the Quality Manager the document owner and one independent reviewer before issue.

4. Emergency changes

An emergency change may be issued with one approval, provided a full review follows within five working days and is recorded in the change log.

All changes are communicated to the people who use the document.

Send for approval

Starts the Document review and approval workflow: owner review, then independent approval, then read and acknowledge.

Approver[Quality lead]