Library / ISO 13485 / Quality Management System
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Standard operating procedure · v2

Control of Document Changes

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Needs reviewOwner Quality Manager ISO 13485 4.2.4Change controlRead and acknowledge1 task

1. Purpose

This SOP controls changes to QMS documents, so that every update is reviewed, approved before issue, communicated and applied consistently, in line with ISO 13485:2016 clause 4.2.4.

2. Scope

All controlled documents in the Qyro Library, including SOPs, work instructions, forms and records.

3. Approval

Changes are approved by the document owner and the Quality Manager before issue.

4. Emergency changes

[Not yet written]