Quality Management System (QMS) Compliance

Name	Date	Company
[Your Name]	[Date]	[Your Company Name]

Purpose:

This checklist created by the Quality Assurance (QA) team, provides a structured approach for our organizations to review and strengthen their QMS. Focusing on essential elements facilitates the identification of areas for improvement, supports compliance with quality standards, and fosters a culture of quality across the organization.

Documentation and Control:

• QMS documentation is complete, accurate, and up-to-date.

• Document control processes ensure version control and accessibility.

• Procedures for document creation, review, approval, and distribution are documented.

• Records of changes to documents are maintained.

• Documented evidence of employee training on document control procedures.

Process Management:

• Core business processes are identified and documented.

• Process interactions and dependencies are understood and managed.

• Key personnel are trained on defined processes.

• Process performance metrics are established and regularly reviewed.

• Periodic reviews ensure processes align with organizational goals.

Monitoring and Measurement:

• Key performance indicators (KPIs) are defined and regularly monitored.

• Measurement equipment and tools are calibrated and maintained.

• Data collection processes are accurate and reliable.

• Regular internal audits of monitoring and measurement processes.

• Corrective actions are taken based on monitoring and measurement findings.

Continuous Improvement:

• Systems are in place to identify opportunities for improvement.

• Continuous improvement initiatives are documented and implemented.

• Employee feedback is actively sought for process improvement ideas.

• Regular management reviews to identify areas for enhancement.

• Lessons learned from corrective actions are incorporated into the QMS.

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