Ten Tips for Moving to ISO 9001:2000 – 2. Determine Scope and Permissible Exclusions

ISO 9001:2000 is intended to be generic and applicable to all organizations, regardless of type, size, and product category. However, not all requirements in the new standard will necessarily be relevant to all organizations. Under certain circumstances, an organization may exclude some specific requirements.

Clause 1.2, Application, in ISO 9001:2000 states that requirements can be excluded only if they are limited to clause 7, Product Realization. Exclusions are acceptable only if they do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

If you find your organization cannot apply a Product Realization requirement, you must define and justify the exclusion in the quality manual. In addition, any publicly available documents such as registration certificates and marketing materials should be carefully phrased to avoid confusing or misleading customers and end users regarding the scope of your quality management system.

Part of defining the scope of your system is deciding on the products and sites to include for registration purposes. A clear description of the scope is of increased importance since certificates cannot be issued for ISO 9002 or ISO 9003 after the transition period ends in December 2003.

Another consideration is that any outsourced processes must be identified and controlled. If a product realization process is outsourced to an external organization, that is not adequate justification for excluding the process from your quality management system.

Refer to clause 4.1, General Requirements, in ISO 9001:2000 for the specific outsourcing requirement. See the Clause 1.2 guidance at http://www.iso.ch/iso/en/iso9000-14000/iso9000/2000rev6.html