Slide 21 of 262
ISO 9000 was originally quite physical product production (manufacturing) centric. In an attempt to address related issues there were 3 versions of the standard. They were identical with one exception: each ascending document was a subset of the previous document. ISO 9001 was the complete document. ISO 9002 was a subset of ISO 9001 - Design was omitted. ISO 9003 was a subset of ISO9002 - this was originally the document which addressed servicing companies.
Each company is different. Each type of business is different. Interpretations often come into play. Design is a good example. One typically thinks of a physical product when the word Design is used. However, many things are designed, including systems. An example is hospital registration where design applies to their systems, such as Code Blue response, individual treatment plans and evacuation plans.
The year 2000 version addresses these issues through the exclusion clause.
Differences In Sectors
1.2 Permissible exclusions
The organization may only exclude quality management system requirements that neither affect the organization's ability, nor absolve it from its responsibility, to provide product that meets customer and applicable regulatory requirements. These exclusions are limited to those requirements within clause 7 (see also 5.5.5), and may be due to the following:
(a) the nature of the organization's product;
(b) customer requirements;
(c) applicable regulatory requirements.
Where permissible exclusions are exceeded, conformity to this International Standard should not be claimed. This includes situations where the fulfillment of regulatory requirements permits exclusions that exceed those allowed by this International Standard.