Dear Readers
I am including this taken from iso.org,hoping it will help clear up and to make 7.3 easier.
Justification for exclusion
If an organization identifies requirements of clause 7 of ISO 9001:2008 that cannot be applied to its activities, the organization can consider exclusion of these requirements, provided there is valid justification.
The exclusion of requirements of clause 7 of ISO 9001:2008 is only acceptable if
“such exclusions do not affect the organization’s ability or responsibility to consistently provide product that meets customer and applicable statutory and regulatory requirements.” The appropriateness of the exclusion depends on considerations of items such as:
- Who is the customer ?
- What is the product ?
- What are the requirements (stated and not stated) related to the product ?
In some cases the exclusion may not be justified
depending on who is the customer, and what is the product.
It should be noted that ISO 9001:2008 sub-clause
1.2 Application can be applied to individual requirements or sub-clauses of clause
7 Product realization. For example, an organization may exclude part of (f) of sub-clause
7.5.1 Control of production and service provision, if the organization has no accountability for post-delivery activities.
Sub-clause
4.2.2 Quality manual of ISO 9001:2008 states:
“The organization shall establish and maintain a quality manual that includes
(a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),..…”
All exclusions need to be expressed in the quality manual (with valid justifications) and have to be consistent with the scope of the organization’s QMS. Any publicly available documents, promoting conformance to ISO 9001:2008, should clearly state the scope of the QMS in a way that will not mislead customers and end users. This should ensure that the necessary information is available for the user to determine which categories of product and product realization processes are included. In addition, the scope of the QMS should be explicit in stating the responsibility for product design and development and other principal realization processes such as manufacturing, sales and services.
When an organization is evaluating whether it can exclude requirements from its QMS,
it should carefully evaluate the impact of such exclusions from the viewpoint of its customer. If there is an impact on the customer, the exclusion would not be justified, since ensuring the conformity of delivered products to customer requirements is a key element of ISO 9001:2008.
Also, organizations considering exclusions should recognize that customers often have no knowledge of the internal operations of the organization from whom they purchase products (
and really do not care how or where organizations design, manufacture or support products). The customer looks at the organization as an entity and expects all elements of the organization (e.g. design, manufacturing, purchasing, repair) to work together to ensure the conformity of its products.