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4.

1 - Internal External Issues

4.2 - Interested Parties Requirements

4.3 - Scope of the QMS

4.4 - Operations Process

5.2 - Quality Policy

5.3 - R&R Authorities

6.2 - Quality Objectives-Action Plan

7.1.5 - Calibration – Monitoring & Measuring

7.2 - Competence Records

7.5 – Distribution, change control, External Origin, Retention

8.1 - Operational Plan

Conformity of Products/Service

8.2.3 - Products Requirements Review

8.3 - Design Inputs, Output, Review Validation, change

8.4 - Supplier evaluation, Selection and Performance Monitoring, re-evaluation.

8.5.1 - characteristics of the products to be produced, the services to be provided, the activities to be
performed

monitoring and measurement activities at appropriate stages, monitoring and measurement activities at
appropriate stages

the validation, and periodic revalidation

8.5.2 - documented information necessary to enable traceability

8.5.3 - documented information on Customers or external providers.

8.5.6 – Change Management

8.6 - release of products and services

8.7 – NCR, Concessional acceptance, Re-Verification of Correction

9.1.2 – Customer Satisfaction

9.2 - Audit Programme, Audit Results.

9.3 – Result of Management Review

10.2 - Correction & CA

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