Q04 Core Concepts (QMS)
Core Concepts of Quality Management System (QMS) are the typical concepts that are applied to each of the processes that make up QMS:
- Proper Documentation Practices and Control
- Change Management (affecting Product Quality)
- Risk to each process should be identified, mitigated and controlled. During this process, risk vs benefits should be evaluated
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E01-0101 Risk Management (FMECA)
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E02-0201 CHANGE CONTROL (ENGINEERING)
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E60-50-01 The Risk Assessment Blueprint for Business
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Q00-0001 QUALITY MANAGEMENT SYSTEM FLOWCHART (MS Visio)
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Q04-0102 DOCUMENT CONTROL PROCEDURE
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Q04-0103 GOOD DOCUMENTATION PRACTICE
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Q04-0104 DOCUMENT SIGNATURE REGISTER
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Q04-0110 CHANGE CONTROL
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Q04-0111 DOCUMENT CHANGE CONTROL SOP
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Q07-8001 DEVIATION REPORTING PROCEDURE
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Q07-8002 DEVIATION INVESTIGATION PROCEDURE
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Q07-8003 LABORATORY DEVIATION INVESTIGATION
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