Scope Statements on Registration Certificates

Scope Statements on Registration Certificates

Many of our clients struggle with developing a Scope for inclusion in their Quality Manual. Some manuals that I have seen say something like “Our Quality System conforms to ISO 9000.” Unfortunately, while it’s true, that’s not a valid statement for a Scope. Here’s the “official” interpretation of that requirement.

The International Accreditation Forum (IAF) has issued the following guidance for registration certificates:

Certificates issued to ISO 9001:2000 shall state clearly in words the scope of the quality management system in a way that will not mislead customers, and shall ensure that information is available for the user to determine which categories of product and product realization processes are included within the scope of registration. (Emphasis added)

In particular, scope statements shall be explicit in stating the responsibility for product design and development and other principal realization processes, such as, manufacturing, sales, and service.

The exclusion of clause 7 requirements may relate to all or only some of the product categories that are within the scope of the quality management system. Justification for excluding these requirements must be given in the quality manual and the registration body must review the validity of any such exclusions during certification and surveillance audits.

If the organization has responsibility for (and realizes or outsources) the design and development process, the scope statement for registration must include the words "Design of ...", "Development of ...", or "Design and development of ....”

According to the IAF, the following sentence must appear on all certificates issued to ISO 9001:2000:

"Further clarifications regarding the scope of this certificate and the applicability of ISO 9001:2000 requirements may be obtained by consulting the organization."
(Registrars always miss this one!)

How does your Scope measure up? Email me a copy for a FREE analysis at mailto:george@4iqc.com