Application of Clause 7.3 - Design and Development

Application of Clause 7.3 - Design and Development

Ever since ISO 9001:2000 replaced the 1994 editions of ISO 9001, ISO 9002, and ISO 9003, it has been a struggle for companies to decide if their quality management system includes design and development. As a result, the International Accreditation Forum (IAF) issued the following guidance:

If an organization has responsibility for, and performs or outsources the design and development of products that are within the scope of its certification, then clause 7.3 of ISO 9001:2000 shall be included in the quality management system.

When assessing the validity of a request to exclude clause 7.3 from the system scope, the IAF points to the ISO 9000:2005 definition of design and development: a set of processes that transforms requirements into specified characteristics or into the specification of a product, process, or system.

If an organization is not provided with the product characteristics needed to plan its product realization processes and has to define those characteristics based on customer (or regulatory) requirements, then this is, by definition, design and development.


An organization may have the responsibility and authority to make changes to the product specification or to the product characteristics, even though it was not responsible for the original design and development process. In this situation, some requirements of clause 7.3 may not be applicable, but clause 7.3 cannot be excluded in its entirety.

An organization may not be responsible for the design and development of all the products within the scope of the quality management system. Clause 4.1 applies if an organization chooses to outsource the design and development process.


Although design and development has traditionally focused on tangible products, it is equally applicable when the product of an organization is a "service".