| 1.What do you monitor in accordance with the requirements in 8.2.3 clause? |
| ISO9001: 2000 requires in 8.2.3 clause to monitor " quality management system processes". But already it requires in 8.2.2 clause to audit " quality management system activities". Do the words of " quality management system processes" has special meaning other than " quality management system activities"? |
| If you look at the corresponded section of ISO9004: 2000, you may find words of "capability, reaction time, cycle time or throughput" so and so, which are not related to "quality management processes", rather related to "product realization processes". |
| The requirement of 8.2.3 clause should be monitoring of "product realization processes" not of " quality management system processes". |
| This confusion is one of the problems which ISO9001: 2000 has. |
| 2. The same confusion in ISO9001: 2000 |
| NOTE in 4.1 clause explains that " processes needed for the quality management system" should include processes for management activities, provision of resources, product realization and measurement. This NOTE makes a basic confusion, because " processes needed for the quality management system" is another thing than "product realization processes". |
| 3.Distinguishing between quality management system requirements and product requirements |
| ISO9000-1: 1994 says in the 4.3 clauses that the ISO9000 family of International Standards makes a distinction between quality management system requirements and product requirements. By means of this distinction, the ISO9000 family applies to organizations providing products of all generic product categories, and to all product quality characteristics. The quality management system requirements are complementary to the technical requirements of the product. |
| The applicable technical specifications of the product (e.g. as set out in product standards) and technical specifications of the processes are separate and distinct from the applicable ISO9000 family requirements or guidance. |
| "Product realization processes" are corresponding with above technical processes those are separate and distinct from the quality management system. |
| The clear distinction has disappeared in ISO9001: 2000 and made confusion now. |
| 4.The cause of the confusion |
| ISO9001: 2000 Standards are based on the concept of PDCA cycle. But when you use this cycle, you have to be careful, because the cycle is a continual improvement cycle, not a management cycle. Often it is mistaken as a management cycle. |
| "Do" in PDCA cycle is not management activities. It is product realization activities. |
| I think ISO9001: 2000 has mistaken the PDCA cycle as a management cycle and it includes product realization activities (Do) in management activities. |
| Therefore, for example, " 7.3 Design and development " in ISO9001: 2000 should be " 7.3 Management of design and developments ", because " design and development" process is a product realization process and " management of design and developments" process is a management process. Both are separate and distinct from each other. |