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Improving Quality through Change Control: Implementing a QMS to Safeguard Quality during Changes
  • Centralize and structure change requests
  • Establish a change committee adapted to the context
  • Evaluate impacts on products and processes
  • Define action plans before and after the change has been implemented
  • Track evidence, justifications, and electronic signatures
  • Implement, monitor, and assess the effectiveness of actions
  • Identify risks at all stages of the process.

A quality audit is the systematic examination of an organization’s quality management system (QMS), which can be carried out by an internal or external quality auditor or an audit team. Audits are a vital part of an organization’s quality management process and is an essential element in the ISO quality system standard, ISO 9001.

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