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| ISO 9001:1994 |
ISO 9001:2000 |
| 1. Scope |
1 |
| 2. Normative Reference |
2 |
| 3. Definitions |
3 |
| 4. Quality System Requirements |
- |
| 4.1 Management Responsibility |
- |
| 4.1.1 Quality Policy |
5.1, 5.3, 5.4.1 |
| 4.1.2 Organization |
- |
| 4.1.2.1 Responsibility and Authority |
5.5.1 |
| 4.1.2.2 Resources |
6.1, 6.2.1 |
| 4.1.2.3 Management Representative |
5.5.2 |
| 4.1.3 Management Review |
5.6.1, 8.5.1 |
| 4.2 Quality System |
- |
| 4.2.1 General |
4.1, 4.2.2 |
| 4.2.2 Quality System Procedures |
4.2.1 |
| 4.2.3 Quality Planning |
5.4.2, 7.1 |
| 4.3 Contract Review |
- |
| 4.3.1 General |
- |
| 4.3.2 Review |
5.2, 7.2.1, 7.2.2, 7.2.3 |
| 4.3.3 Amendment to a Contract |
7.2.2 |
| 4.3.4 Records |
7.2.2 |
| 4.4 Design Control |
- |
| 4.4.1 General |
- |
| 4.4.2 Design and Development Planning |
7.3.1 |
| 4.4.3 Organizational and Technical Interfaces |
7.3.1 |
| 4.4.4 Design Input |
7.2.1, 7.3.2 |
| 4.4.5 Design Output |
7.3.3 |
| 4.4.6 Design Review |
7.3.4 |
| 4.4.7 Design Verification |
7.3.5 |
| 4.4.8 Design Validation |
7.3.6 |
| 4.4.9 Design Changes |
7.3.7 |
| 4.5 Document and Data Control |
- |
| 4.5.1 General |
4.2.3 |
| 4.5.2 Document and Data Approval and Issue |
4.2.3 |
| 4.5.3 Document and Data Changes |
4.2.3 |
| 4.6 Purchasing |
- |
| 4.6.1 General |
- |
| 4.6.2 Evaluation of Subcontractors |
7.4.1 |
| 4.6.3 Purchasing Data |
7.4.2 |
| 4.6.4 Verification of Purchased Product
|
7.4.3 |
| 4.7 Control of Customer-Supplied Product
|
7.5.4 |
| 4.8 Product Identification and Traceability
|
7.5.3 |
| 4.9 Process Control |
6.3, 6.4, 7.5.1, 7.5.2 |
| 4.10 Inspection and Testing |
- |
| 4.10.1 General |
7.1, 8.1 |
| 4.10.2 Receiving Inspection and Testing |
7.4.3, 8.2.4 |
| 4.10.3 In-Process Inspection and Testing |
8.2.4 |
| 4.10.4 Final Inspection and Testing |
8.2.4 |
| 4.10.5 Inspection and Test Records |
7.5.3, 8.2.4 |
| 4.11 Control of Inspection, Measuring,
and Test Equipment |
- |
| 4.11.1 General |
7.6 |
| 4.11.2 Control Procedure |
7.6 |
| 4.12 Inspection and Test Status |
7.5.3 |
| 4.13 Control of Nonconforming Product |
- |
| 4.13.1 General |
8.3 |
| 4.13.2 Review and Dispositioning of Nonconforming
Product |
8.3 |
| 4.14 Corrective and Preventive Action |
- |
| 4.14.1 General |
8.5.2, 8.5.3 |
| 4.14.2 Corrective Action |
8.5.2 |
| 4.14.3 Preventive Action |
8.5.3 |
| 4.15 Handling, Storage, Packaging, Preservation,
and Delivery |
- |
| 4.15.1 General |
- |
| 4.15.2 Handling |
7.5.5 |
| 4.14.3 Storage |
7.5.5 |
| 4.15.4 Packaging |
7.5.5 |
| 4.15.5 Preservation |
7.5.5 |
| 4.15.6 Delivery |
7.5.1, 7.5.5 |
| 4.16 Control of Quality Records |
4.2.4 |
| 4.17 Internal Quality Audits |
8.2.2, 8.2.3 |
| 4.18 Training |
6.2.1, 6.2.2 |
| 4.19 Servicing |
7.1, 7.5.1 |
| 4.20 Statistical Techniques |
- |
| 4.20.1 Identification of Need |
8.1, 8.2.3, 8.2.4, 8.4 |
| 4.20.2 Procedures |
8.1, 8.2.3, 8.2.4, 8.4 |
About the Author
Larry Whittington is President of Whittington &
Associates, a quality system training, consulting, and auditing company
located in Marietta, Georgia. He is an ASQ Certified Software Quality
Engineer and Quality Auditor. Both the RAB and IRCA have certified him
as an ISO 9000 Lead Auditor. He is also a trained TickIT Lead Auditor
for software systems and a certified QS-9000 Lead Auditor for the automotive
industry. Mr. Whittington can be contacted at 770-517-7944,
or by e-mail at Larry@WhittingtonAssociates.com.
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