ISO 9001:1994 |
ISO 9001:2000 |
1 Scope 1 |
|
2 Normative reference |
2 |
3 Definitions |
3 |
4 Quality system requirements [title only] |
|
4.1 Management responsibility [title only] |
|
4.1.1 Quality policy |
5.1 + 5.3 + 5.4.1 |
4.1.2 Organization [title only] |
|
4.1.2.1 Responsibility and authority |
5.5.1 |
4.1.2.2 Resources |
5.1 + 6.1 + 6.2.1 + 6.3 |
4.1.2.3 Management representative |
5.5.2 |
4.1.3 Management review |
5.6.1 + 5.6.2 + 5.6.3 + 8,5.1 |
4.2 Quality system [fitle only] |
|
4.2.1 General |
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 |
4.2.2 Quality system procedures |
4.2.1 |
4.2.3 Quality planning |
5.4.2 + 6.2.1 + 7.1 |
4.3 Contract review [title only] |
|
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 [title only] |
|
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 |
7.3.1 + 7.3.4 |
4.4.7 Design verification |
7.3.1 +7.3.5 |
4.4.8 Design validation |
7.3.1 + 7.3.6 |
4.4.9 Design changes |
7.3.7 |
4.5 Document and data control [title only] |
|
4.5.1 General |
4.2.1 + 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 [title only] |
|
4.6.1 General |
|
4.6.2 Evaluation of subcontractors |
7.4.1 |
4.6.3 Purchasing data |
7.4.2 |
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 + 7,1 + 7,5,1 + 7,5.2 + 8.2.3 |
4.10 Inspection and testing [title only] |
|
< style='font-family:"Times New Roman">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 |
7.4.3 + 7.5.1 + 82.4 |
4.10.4 Final inspection and testing |
7.4.3 + 82.4 |
4.10.5 Inspection and test records |
7.5.3 + 82.4 |
4.11 Control of inspection, measuring and test equipment [title
only] |
|
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 [title
only] |
|
4.13.1 General |
8.3 |
4.13.2 Review and dispositioning of nonconforming
product |
8:3 |
4.14 Corrective and preventive action [title
only] |
|
4.14.1 General |
8.5.2+8.5.3 |
4.14.2 Corrective action |
8.4 + 8.5.2 |
4.14.3 Preventive action |
8.4 + 8.5.3 |
4.15 Handling, storage, packaging, preservation & delivery
[title only] |
|
4.15.1 General |
|
4.15.2 Handling |
7.5.5 |
4.15.3 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 |
42.4 |
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 [tMle only] |
I |
4.20.1 Identification of need |
+ 82.3 + 8.2.4 + 8.4 |
4.20.2 Procedures |
- - ~8.1 |
4.6.4 Verification of purchased product |
7.4.3 |
1 Scope |
1 |
1.1 General |
|
1.2 Application |
|
2 Normative reference |
2 |
3 Terms and definitions |
3 |
4 Quality management system [title only] |
|
4.1 General requirements |
4.2.1 |
4.2 Documentation requirements [title only] |
|
4.2.1 General |
4.2.1 +4.5.1 |
4.2.2 Quality manual |
4.2.1 |
4.2.3 Control of documents |
4.5.1 + 4.5.2 +4.5.3 |
4.2.4 Control of quality records |
4.16 |
5 Management responsibility [title only] |
|
5.1 Management commitment |
4.1 + 4.1.2.2 + 4.2.1 |
5.2 Customer focus |
4.3.2 |
5.3 Quality policy |
4.1.1 |
5.4 Planning [title only] |
|
5.4.1 Quality objectives |
4.1.1 + 4.2.1 |
5.4.2 Quality management system planning |
4.2.3 |
5.5 Responsibility, authority and communication [title
only] |
|
5.5.1 Responsibility and authority |
4.1.2.1 |
5.5.2 Management representative |
4.1.2.3 |
5.5.3 Internal communication |
|
5.6 Management review [title only] |
4.1.3 |
5.6.1 General |
4.1.3 |
5.6.2 Review input |
4.1.3 |
5.6.3 Review output |
4.1.3 |
6 Resource management [title only] |
|
6.1 Provision of resources |
4.1.2.2 |
6.2 Human resources [title only] |
|
6.2.1 General |
4.1.2.2+4.2.3+4.18 |
6.2.2 Competence, awareness and training |
4.18 |
6.3 Infrastructure |
4.1.2.2 + 4.9 |
6.4 Work environment |
4.9 |
7 Product realization [title only] |
|
7.1 Planning of product realization |
4.2.3 + 4.9 + 4.10.1 |
7.2 Customer-related processes [title only] |
|
7.2.1 Determination of requirements related to the
product |
4.3.2 +4.4.4 |
7.2.2 Review of requirements related to the
product |
4.3.2 + 4.3.3 + 4.3.4 |
7.2.3 Customer communication |
4.3.2 |
7.3 Design and development [title only] |
|
7.3.1 Design and development planning |
4.4.2 + 4.4.3 + 4.4.6 + 4.4.7 + 4.4.8 |
7.3.2 Design and development inputs |
4.4.4 |
7.3.3 Design and development outputs |
4.4.5 |
7.3.4 Design and development review |
4.4.6 |
7.3.5 Design and development verification |
4.4.7 |
7.3.6 Design and development validation |
4.4.8 |
7.3.7 Control of design and development changes |
4.4.9 |
7.4 Purchasing [title only] |
|
7.4.1 Purchasing process |
4.6.2 |
7.4.2 Purchasing information |
4.6.3 |
7.4.3 Verification of purchased product |
4.6.4 + 4.10.2 + 4.10.3 + 4.10.4 |
7.5 Production and service provision [title
only] |
|
7.5.1 Control of production and service
provision |
4.9 + 4.10.3 + 4.15.6 + 4,19 |
7.5.2 Validation of processes for production and service
provision |
4.9 |
7.5.3 Identification and traceability |
4.8 + 4.10.5 + 4.12 |
7.5.4 Customer property |
4.7 |
7.5.5 Preservation of product |
4.152 + 4.15.3 + 4.15.4 +.4.15.5 + 4,15.6 |
7.6 Control of monitoring and measuring
devices |
4.11.1 +4.11.2 |
8 Measurement, analysis and improvement [title
only] |
|
8.1 General |
4.10+4.17+4.20.1 |
8.2 Monitoring and measurement [title only] |
|
8.2.1 Customer safisfaction |
|
8.2.2 Internal audit |
4.17 |
8.2.3 Monitoring and measurement of
processes |
4.9 +4.17 +4.20.1 |
8.2.4 Monitoring and measurement of
product |
4.10.2 + 4.10.3 + 4.10.4 + 4.10.5 + 4.20.1 |
8.3 Control of nonconforming product |
4.13.1 +4.13.2 |
8.4 Analysis of data |
4.14.2+4.14.3+4.20 |
8.5 Improvement [title only] |
|
8.5.1 Continual improvement |
4.1.3 |
18.5.2 Corrective action |
4.14.1 + 4.14.2 |
8.5.3 Preventive action |
4.14.1 +4.14.3 |