ISO 9001:2008 specifies requirements for a quality management system where an organization
needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
Legislation related to this standard
REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93Harmonized/Supporting
Directive 2008/68/EC of the European Parliament and of the council of 24 September 2008 on the inland transport of the dangerous goods
EN ISO 9001:2000
EN ISO 9001:2008
99.60 Withdrawal effective
Sep 15, 2015
EN ISO 9001:2008/AC:2009
EN ISO 9001:2015