quality management systems (qms) - qualityoperations · pdf filequality manual •a...
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On completion of this session, you must:
Understand the concept of qualityUnderstand the importance of satisfying customer requirements
Be familiar with the documentation required to support a Quality Management System (QMS)Be able to develop documentation relevant to QMS
Quality Management Systems (QMS)
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10- 2
Strategic Quality PlanningThe Tools of Quality Improving the System
Quality System
Model
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QMS
Quality Manual
Policy
Procedures
Work Instructions
Documentation
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Quality Manual
• A document specifying the quality management system of an organization (ISO Standards)
• Rule book for organization to function by source of information
• Means of definition responsibility and interrelated activities
• Defines level of quality
• Vehicle for auditing, reviewing and evaluating QMS
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• Include statement of organization policy toward quality control
• Contain details of a management structure, organization,jobdescription and responsibilities
• Requirements, training programme
• Procedures, work instructions
• Copies of all documents eg inspection sheets, purchase forms etc
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Quality Policy
• The overall intentions and directions of an organization related to quality as formally expressed by top management (ISO 9000)
• Clear statement of intent for each activity.
• Must be:
• The appropriate
• Involve everybody
• Out line organizational goals and objectives
• Communicated and implemented
• Understood by all
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Quality Policy cont……
• The basic documentation used for the overall planning and administration of activities which impact on quality
• What has to be carried out?
• Clear concise• Must include:
• basic documents – plan and control all activities
• details how policy is to be implemented
• cover all elements of ISO and detail special aspects of organization
• relatively constant
• easily accessible
• must be able to be tracked back to the quality policy
• not include technical info
• filed in separated manual
• layout must be consistent
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Quality Procedures Include:
• Document data
• Distribution list
• Amendments
• Contents
• List of annexures
• List of tables/illustrations
• Abbreviations 2 acronyms
• Terminology – explanation
• References
• Scope and objective
• Procedure overview and procedure
• Responsibilities
• Relevant forms
•
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Work Instruction
• Provides details to carry out specific job in an exact manner to a predetermined standard• Tells you:
• What has to be done
• Who should do it
• When it should be done
• What supplies and services and equipment
• What criteria need to be satisfied
• Regularly reviewed for
• continuing acceptability
• Validity
• Effectiveness
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What goes into a Work Instruction?
• Document data sheet - who wrote. When approved etc.
• Distribution list
• Amendments
• Contents list
• List of annexures
• List of illustrations, tables
• Abbreviations and acronyms
• Terminology
• References
• Scope and objectives
• Procedure – safety, production, installation
• Responsibility – who can carry out process
• Relevant forms
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Latest ISO Standards
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