A.2 Sequence & Interaction of QMS Processes: Quality Manual

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Quality Manual

www.iso9001help.co.uk
ISO 9001:2015 Quality Management System

A.2 Sequence & Interaction of QMS Processes

Customers & Interested Parties

Management & Review


Customer Processes Customer Satisfaction
Requirements
Strategic Direction,
Operational Purpose Operation &
& Management Product
System Planning
Quality Planning Customer Feedback
Strategic Planning PLAN Customer Perceptions
Production Planning Complaints
Process Planning DO Product Returns
Design Reviews Corrective
Action
Performance
Corrective Action &
Evaluation &
Improvement
Management Review

CHECK ACT

QMS Requirements
QMS Data Points
Policy, Objectives & KPIs
Supplier Metrics
Risk & Opportunity
Process Metrics
Competence & Awareness
Product Metrics
Resources
Service Metrics
Responsibilities & Authority
Non-conformances

Operation & Production Processes

A. New
2. Contract 3. Produce 4. Order
1. Receive Order or
Review Quote Acceptance
Existing
Product?
Existing New

6. Engineering 7. Purchasing & 8. Receiving B. Production


5. Specifications
Change Control Outsourcing Inspection, ID & & Assembly
& Designs
& Validation Controls Traceability Processes
Non-conforming

C. Non-
9. In-process 10. Final 11. Packaging &
12. Dispatch conforming
Inspection Acceptance Product Storage
Outputs

Non-conforming

Support & Assurance Processes

Calibration Documents Customers &


Internal Data Root-cause
Training & Asset /Records & Interested
Audits Analysis Analysis
Maintenance Knowledge Parties

Document Ref. Page 43 of 44

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