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Verify the flow and interaction of all QMS processes are documented and understood.
Are the flow and interactions of QMS processes documented and understood?
Process Sequence and Interactions
Process Interaction Diagrams, Flowcharts
Appendix A
Ensure all required documents for QMS implementation are identified and available.
Are all required documents for QMS implementation identified and available?
Appendix B
Document Overview
Document Lists, Availability Logs
Confirm the organizational structure supports the QMS requirements and responsibilities are clearly defined.
Does the organizational structure support QMS requirements?
Organizational Chart, Job Descriptions
Appendix C
Organization Chart
Are there sufficient resources provided for QMS implementation and maintenance?
Confirm resource provision for implementing and maintaining the QMS.
Resource Plans, Budget Allocations
6. Resource Management
6.1 Provision of Resources
Verify that training needs are identified and addressed for all personnel.
6.2.1 Competency, Awareness, and Training
Are training needs identified and addressed for all personnel?
6.2 Human Resources
Check if competency assessments are conducted regularly.
Are competency assessments conducted regularly?
Verify if position descriptions are regularly reviewed and updated.
Are position descriptions regularly reviewed and updated?
Position Description Documents, Review Logs
6.2.2 Position Descriptions
6.2.3 Personnel Reviews and Appraisals
Ensure performance appraisals are conducted as per schedule.
Are performance appraisals conducted as scheduled?
Appraisal Schedules, Appraisal Records
Verify infrastructure is maintained to support QMS processes.
Is the infrastructure maintained to support QMS processes?
Maintenance Logs, Infrastructure Audit Reports
6.3 Infrastructure
Is the work environment monitored and controlled effectively?
Ensure the work environment is monitored and controlled.
Environmental Monitoring Records, Control Plans
6.4 Work Environment
Does product realization planning include quality objectives, resource needs, and validation activities?
Ensure product realization planning includes all required elements.
7.1 Planning of Product Realization
Product Realization Plans, Quality Objectives
7. Product Realization
Verify the review and determination of customer requirements.
Are customer requirements reviewed and determined accurately?
7.2.1 Determination and Review of Requirements
7.2 Customer-Related Processes
Ensure customer communication is effective and documented.
Is customer communication effective and documented?
Communication Logs, Customer Feedback
7.2.2 Customer Communication
Verify that design and development processes are followed.
Are design and development processes followed and documented?
Design Plans, Development Records
7.3 Design and Development
Check if design reviews are conducted at planned stages.
Are design reviews conducted at planned stages?
Design Review Minutes, Review Schedules
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