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3- Determining the scope of the QMS Product Safety
5.2- Policy
5.3.1 Organizations roles, authorities and
responsibilities Analyzing Risk Preventive action Contingency plans
6.2 Quality objectives and plans to achieve them Measurement system analysis Maintenance and calibration of records
7.2.1 Document competence of workers
7.2.2 Document competence of on the ground training
7.2.3 Document Competence of internal auditors
7.2.4 Document Competence of second party auditor
7.3.1 Document awareness of employees
7.3.2 Document employee empowerment and motivation Document quality management system Must control and document record retention Document engineering specifications
8.2 Document products and services in regard to customer communication Document product and service changes Document the procedure for design and development or products
8.3.2 Document output reviews on design and development Document information on software development Document product design input Document manufacturing process design input Document process to identify special characteristics
8.3.4 Document design and development Documented the product approval process
8.3.5 Document design and development outputs Document the manufacturing process for design output
8.3.6 Document changes for design Supplemental documentation for design and development changes Document supplier selection process Document requirements for externally provided processes, products and services that are considered statutory
and regulatory document process and criteria for supplier evaluation Document records of second-party audit reports
8.5.1. Characteristics of product to be produced and service to be provided