PART 4 - SCOPE DESCRIPTION AND APPLICATION

General

To accommodate the differences between different organisations' activities, ISO 9001:2000 allows for "Application". This only applies to the requirements of clause 7, "Product Realisation" [i.e. the clause that asks an organisation to describe the processes of producing its products or providing its services].

ISO 9001:2000, Clause 1.2 explains the concept of "Application" and, at Clause 4.2.2 requires the Quality Manual to include details and justification for exclusions.

This then allows for a description in the scope of the qms that will differentiate those businesses that supply design and development services, and/or manufacturing services and/or process services and/or service provision. It is the scope of certification that indicates which clauses or sub clauses of section 7 are included or excluded. It also indicates any other specific elements of the organisation's business. Exclusions are only allowed within section 7. You must comply with all the requirements of sections 4, 5, 6 and 8.

Some examples of scope description are:

A solicitor, with no measurement instruments, can justify that ISO 9001 clause 7.6, Control of measuring and monitoring devices, has no bearing on meeting customer requirements and can therefore exclude it.

Similarly, many manufacturing industries simply manufacture to set specifications without themselves designing the product. There is therefore a valid justification to exclude ISO 9001:2000 clause 7.3 Design and/or development.

Scopes of Certification will appropriately reflect these different descriptions of a businesses' activities. An architect may indicate a scope of:

"The design of houses and the project management of their construction"

Whereas a builder using these designs would perhaps indicate:

"The building of houses".

A training organisation may have the scope:

"The development and running of training courses"

Or, if it only runs the courses:

"The running of training courses".

The ISO committee responsible for the development of ISO 9000:2000 has issued Guidance on "Application" that may be referred to for further help [look at the ISO/TC176/SC2 website http://www.bsi.org.uk/iso-tc176-sc2]. The following example is drawn from this document.

The "DEF Bottling Organisation" has a manufacturing facility that produces soft drinks according to product and packaging specifications provided by its parent organisation. It also manufactures products under license according to full product and packaging specifications provided by another independent organisation. The two sets of specifications meet all regulatory requirements and have not changed for years.

The manufacturing plant of DEF Bottling Organisation excludes from its QMS Clause 7.3 of ISO 9001:2000 [Design & Development], because this clause is not applicable to the manufacturing plant's operations. Full justification for this decision is provided in DEF's Quality Manual, nor do any publicity materials imply that the manufacturing plant has any design activity relating to its products.

Note: The fact that the design has not changed for years is irrelevant to the exclusion of clause 7.3 for DEF's QMS. Changing regulatory requirements may necessitate changes to the product design and the application of clause 7.3 by the organisation responsible for the design, which in this case is not DEF Bottling organisation.

The corporate purchasing division of DEF's parent organisation negotiates all raw material and packaging purchases, in order to negotiate better prices.

The organisation recognizes that, even though the manufacturing unit does not carry out the operational part of purchasing, it has an important input into the process, particularly the specification and verification of the purchased product. It therefore does not exclude Clause 7.4 ["Purchasing"] from its QMS, and explains in its documented QMS the way in which the purchasing process operates, including a description of the interfaces between the manufacturing plant and the corporate purchasing division. It also applies the requirements of clause 7.4 to other purchased products and services, which are managed locally.

At all times you are advised to discuss your scope of certification and any possible "Application" of your systems with your assessment body, consultant, independent adviser or customer.

Previous: Part Three

Next: Part Five

Back to title page