ISO 9001:2015 specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
When the standard is harmonized under a directive or regulation, the word Harmonized appear. When such an inscription does not appear, it means that the standard is related to / supporting the relevant directive or regulation.
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
Directive 2008/68/EC of the European Parliament and of the council of 24 September 2008 on the inland transport of the dangerous goods
БДС EN ISO 9001:2008
БДС EN ISO 9001:2015
60.60 Standard published
Sep 25, 2015