-- SungYong - 23 Mar 2009

AS9100B additional requirements to ISO 9001:2000 - OBSOLETE

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Clause |

Heading ||

Additional topics | |

4.2.1 |

Documentation requirements ||

QMS requirements of regulator authorities
Access to documentation by personnel
Access to documentation by customers and regulators | |

4.2.2 ||

Quality manual |

Relationship between procedures and AS9100 requirements | |

4.2.3 ||

Control of documents |

Coordination of document changes | |

4.2.4 ||

Control of records |

Supplier records
Availability of records | |

4.3 || |

Configuration management | |

5.5.2 ||

Management representative |

Organizational freedom | |

7.1 ||

Planning of product realization |

Operation and maintenance resources | |

7.2.2 ||

Review of requirements related to the product |

Review of risks | |

7.3.1 ||

Design and development planning |

Structure of work elements
Work element tasks and resources
Work element review
Task definition | |

7.3.3 ||

Design and development outputs |

Key characteristics
Manufacturing, operating and maintenance data | |

7.3.4 ||

Design and development review |

Stage authorization | |

7.3.6 ||

Design and development validation |

Documentation of verification and validation
Verification and validation testing | |

7.3.7 ||

Control of design and development changes |

Customer and regulator approval of changes | |

7.4.1 ||

Purchasing process |

Responsibility for purchased products
Register of approved suppliers
Supplier performance review
Supplier approval authority | |

7.4.2 ||

Purchasing information |

Requirements for identification, acceptance, nonconforming material, changes, rights of access and requirement flow-down | |

7.4.3 ||

Verification of purchased product |

Verification activities
Use of incoming product
Supplier test reports
Delegation of verification activities
Customer verification at source | |

7.5.1 ||

Control of production and service provision |

Planning for key characteristics
In-process verification points
Tooling design and manufacture
Product accountability
Evidence of completion
Foreign objects
Monitoring and control of utilities
Workmanship criteria
Production documentation
Production process changes
Production equipment, tools and NC machines
Work transfer to external facilities
Service operations | |

7.5.2 ||

Validation of processes |

Criteria for qualification and approval
Documented process specifications | |

7.5.3 ||

Identification and traceability |

Configuration identification
Control of acceptance media
Traceability | |

7.5.5 ||

Preservation of product |

Cleaning
Foreign objects
Sensitive products
Safety warnings
Shelf life
Hazardous materials | |

7.6 ||

Control of monitoring and measuring devices |

Device registers
Calibration process
Environmental requirements
Recall methods | |

8.2.2 ||

Internal audits |

Audit tools and techniques | |

8.2.3 ||

Monitoring and measurement of processes |

Process nonconformity | |

8.2.4 ||

Monitoring and measurement of product |

Key characteristics
Sampling inspection
Use of product
Inspection documentation
First article inspection | |

8.3 ||

Control of nonconforming product |

Disposition authority
Authorization use of nonconforming product
Scrapped product
Reporting of nonconforming product | |

8.5.2 ||

Corrective action |

Supplier non-conformities
Non-fulfilment of corrective actions |