A Quality Management System (QMS) is a collection of processes and responsibilities, part of organizational governance, aimed at consistently delivering products and services that meet customer expectations and regulatory compliance. In this series of blog posts we discuss some of the essential elements of a QMS.
Importance of Change Control
Change control is a systematic approach to managing any changes made to the product, service or whatever is in scope of the quality management system. The purpose is mainly to ensure that no unnecessary changes are made and that risks towards meeting customer expectations and regulatory compliance are controlled.
Key Elements
Changes should be requested and go through a process of evaluation and planning. Once the plan approved by the appropriate roles, it is carried out and checked for conformance to the expected criteria. The qualified roles finally approve and close the change when satisfied or define additional follow-up actions.
Documentation
Documented information should be retained including the ID of people approving the change, the date and time of approval and the evidence of conformance.
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