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Quality Manual

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ISO 9001:2015 Quality Management System

A.2 Sequence & Interaction of QMS Processes

Customers & Interested Parties

Management & Review Processes


Customer Requirements Customer Satisfaction
Strategic Direction,
Operational Purpose Operation & Product
& Management Realization
Quality Planning System Planning Customer Feedback
Strategic Planning Customer Perceptions
PLAN DO Complaints
Production Planning
Process Planning Product Returns
Design Reviews Performance Corrective Action
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 or
2. Contract 3. Produce 4. Order
1. Receive Order Existing
Review Quote Acceptance
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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