Guidance on Permissible Exclusions for ISO 9001:2000

The current ISO 9001, ISO 9002, and ISO 9003 standards are being replaced by the single ISO 9001:2000 standard. As a result, some of its requirements may not be applicable to all organizations.

Clause 1.2 of ISO 9001:2000 defines the conditions under which an organization can exclude certain requirements that are not relevant to their quality management system.

Requirements may only be excluded if they do not affect an organization’s ability, or absolve it from its responsibility, to provide product that meets customer and applicable regulatory requirements. Exclusions may be possible due to the nature of your product, or your customer requirements, but are limited to just the requirements in clause 7, Product Realization. An organization should not claim conformity to the standard if the permissible exclusions are exceeded. This includes situations where meeting regulatory requirements permits exclusions that exceed those allowed by the standard. In addition, the quality manual must describe the scope of your quality management system, including the details of, and justification for, any excluded requirements.

Clause 1.2 does not place any restrictions on the scope of your quality management system, it only refers to possibly excluding a requirement of ISO 9001:2000 from the selected scope. However, if an organization implements a quality management system with a restricted application to its product line, this limitation should be made clear in the quality manual to avoid misleading customers.

Permissible exclusions do not apply just to whole clauses. There may be situations where only a portion of the requirements in one of the clauses of the Product Realization section can be excluded.

Also, just because an activity is outsourced, or carried out by another group, that may not by itself be adequate justification for excluding the activity from the quality management system. The organization may remain responsible for coordinating the activity.

So, you can’t discard a requirement just because you don’t want to do it. You can’t drop a requirement because it hasn’t been part of your system in the past. Clauses can’t be excluded just because regulatory bodies don’t require them.

As an example, if a corporate group handles purchasing for a manufacturing site, the site would still be involved in the supplier evaluation process, especially as it relates to verification of purchased product. As a result, clause 7.4 on Purchasing can’t be excluded from the scope of that quality management system. The site quality manual would have to explain the way they interface with the corporate group on purchasing activities.

Organizations that do not design or develop the products within their scope may exclude clause 7.3, Design and/or Development.

An organization will be able to exclude clause 7.5.3, Customer Property, if it doesn’t apply to them. However, remember that clause 7.5.3 also applies to intellectual property (information provided in confidence).

If the products within the system scope are of the type that cannot be maintained after sale, then that servicing portion of clause 7.5, Production and Service Operations, can be excluded.

Remember, your Registrar will need to confirm your ISO 9001 scope of registration and agree with any excluded requirements.