资料提供: MC
编辑、评述:余彤鹰
这是CD1阶段完成后不久做的一份资料,现在已经“过时”了。留供参考。
整个ISO9000族的结构做了调整,由四个主要标准和数个支撑性技术报告构成:
| 编号 | 标题 |
| 0 | Introduction |
| 0.1 | General |
| 0.2 | Process model |
| 0.3 | Compatibility with other management system disciplines |
| 1 | Scope |
| 1.1 | General |
| 1.2 | Reduced scope and tailoring |
| 1.2.1 | General |
| 1.2.2 | Reduced scope - design and development excluded |
| 1.2.3 | Tailoring |
| 2 | Normative reference |
| 3 | Terms and definitions |
| 4 | Quality management system requirements |
| 5 | Management responsibility |
| 5.1 | General |
| 5.2 | Customer needs and requirements |
| 5.3 | Quality policy |
| 5.4 | Quality objectives and planning |
| 5.4.1 | Quality objectives |
| 5.4.2 | Quality planning |
| 5.5 | Quality management system |
| 5.5.1 | General |
| 5.5.2 | Responsibility and authority |
| 5.5.3 | Quality manual |
| 5.5.4 | Systems procedures |
| 5.5.5 | Management representative |
| 5.5.6 | Control of documents |
| 5.5.7 | Control of quality records |
| 5.6 | Management review |
| 6 | Resource management |
| 6.1 | General |
| 6.2 | Human resources |
| 6.2.1 | Assignment of personnel |
| 6.2.2 | Training, qualification and competence |
| 6.3 | Other resources |
| 6.3.1 | Information |
| 6.3.2 | Infrastructure |
| 6.3.3 | Work environment |
| 7 | Process Management |
| 7.1 | General |
| 7.2 | Customer-related process |
| 7.2.1 | Identification of customer requirements |
| 7.2.2 | Review of customer requirements |
| 7.2.3 | Review of ability to meet defined requirement |
| 7.2.4 | Customer communication |
| 7.2.5 | Customer property |
| 7.3 | Design and development |
| 7.3.1 | General |
| 7.3.2 | Design and development inputs |
| 7.3.3 | Design and development outputs |
| 7.3.4 | Design and development review |
| 7.3.5 | Design and development verification |
| 7.3.6 | Design and development validation |
| 7.3.7 | Design and development changes |
| 7.4 | Purchasing |
| 7.4.1 | General |
| 7.4.2 | Purchasing information |
| 7.4.3 | Verification of purchased product &/or services |
| 7.5 | Production and service operations |
| 7.5.1 | General |
| 7.5.2 | Identification and traceability |
| 7.5.3 | Handling, packaging, storage, preservation & delivery |
| 7.5.4 | Validation of processes |
| 7.6 | Control of nonconformity |
| 7.6.1 | General |
| 7.6.2 | Nonconformity review and disposition |
| 7.7 | Post delivery services |
| 8 | Measurement, analysis and improvement |
| 8.1 | General |
| 8.2 | Measurement |
| 8.2.1 | Measurements of system performance |
| 8.2.1.1 | Measurements of customer satisfaction |
| 8.2.1.2 | Internal audit |
| 8.2.2 | Measurements of processes |
| 8.2.3 | Measurement of product &/or service |
| 8.2.4 | Control of measuring, inspection and test equipment |
| 8.3 | Analysis of data |
| 8.4 | Improvement |
| 8.4.1 | Corrective action |
| 8.4.2 | Preventive action |
| 8.4.3 | Improvement processes |
在这个修订稿中,对操作上的实质要求,主要被概括在以下四个章节之中:
这个框架,如果用“过程化”的管理语言来说,就是一些基本业务过程,和支持的过程,包括高层(决策、领导等)的过程。
关于企业理论与实践领域的“过程中心观”,我们有专题的讨论。我们看到新的修订草案中,十分充分地体现了这种观念的影响,或者说,是主导了这个版本标准的开发。从上面的结构我们可以看出,标准的内容比较有条理,并且也没有明显的漏洞,这与94版比,有很大的改善。我觉得,这个架构,反应了90年代以来管理实践与理论领域的一些新东西,可以说,和我们熟悉的六、七十年代的 TQC 相比,才算有了一些新意。
与ISO14000现行标准对照,我们可以看到结构上有更好的对应性。这是顺应广大使用者的要求而强化的一项工作,这个原则,不单是这一个标准中要体现,将来在所有相关标准修订中都要体现。最终,不同的体系中相同的要素将是共享的,各种不同的涉及管理体系的标准,例如关于环境、职业保健、安全等,将共同集成在一个统一的管理体系中。
( 1998-11-29 )
98-12-6: 根据MC的提点,改正了几处错误或不清楚的地方。
企业工程论坛 http://www.ee-forum.org/ 1998