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Control of Document Changes

Document ID: Qyro-SOP-A002
Owner: Quality Manager

1. Purpose

This SOP defines the process for controlling changes to QMS documents to ensure that updates are:

  • Reviewed for adequacy
  • Approved before issue
  • Communicated to relevant personnel
  • Implemented consistently across the organisation

Aligned with ISO 13485:2016 clause 4.2.4.

2. Audience