Design and development and exclusions

Organisations that seek accredited certification to the quality management systems standard ISO 9001: 2000, or transfer to the new edition of the standard from the 1994 version, can exclude any part of sub-clause 7, provided such exclusions can be justified. Exclusions can be easily justified in some cases, but others, such as sub-clause 7.3, ´design and development´, are sometimes more difficult to justify. This paper gives an interpretation of sub-clause 7.3, and discusses exclusions in manufacturing companies and service industries (a field marketing company, and nursing homes).