Quality Management System (QMS) Audit
The QMS audit is designed to determine the existence and effectiveness of appropriate, documented
QMS procedures in a factory.
Audit Scope
The areas covered in the audit include:
• GME – General Management Elements
o Building Exterior and Interior
o Layout/Product Flow
o Lighting and Ventilation
o Cleaning
o Pest Control
o Foreign Body Contamination
• Senior Management Commitment & Continual Improvement
• Management System
o Quality Manual
o Quality Policy Statement
o Organizational Structure, Responsibility and Management Authority
o Customer Focus
o Management Review
o Internal Audit
o Supplier Approval and Performance Monitoring
o Product Identification and Traceability
o Issue and Complaint Handling
o Procedures
o Document Control
o Record Keeping
o Opening Meeting – The assigned auditor will meet with factory management and
review the audit scope and process.
o Factory Tour – The auditor will tour the factory from the incoming material area to the
finished product warehouse. During the tour they will make general observation and
identify the areas of the factory where they will return to conduct the detailed portions
of the audit. The tour helps the auditor visualize the factory layout to optimize
subsequent activities.
o Sectional Audit – The auditor will visit the specific areas of the factory covered within
the scope and utilize the methodologies described above to assess compliance.
o Draft Findings – The auditor will then need a private area to review his findings and
prepare the draft for review during the closing meeting.
o Closing meeting – The auditor presents the draft findings to factory management.
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