IsO9001:2000E) Quality management systems -Requirements IS This International Standard specifies requirements for a quality management system where an a)needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b)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 regulatory requirements. NOTE In this International Standard, the term"product"applies only to the product intended for, required by, a customer. 1. 2 Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size ad product provided. Where any requirements(s)of this International Standard 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 this International Standard 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 regulatory requirements. 2 Normative reference The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subseq uent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of iso and IEC maintain registers of currently valid International Standards. ISO 9000: 2000, Quality management systems -Fundamentals and vocabulary 3 Terms For the purposes of this International Standard, the terms and definitions given in Iso 9000 apply. The following terms, used in this edition of iso 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used supplier organization customer OISO2000-All rights reservedISO 9001： 2000(E) ©ISO2000 – All rights reserved 1 Quality management systems –Requirements 1 Scope 1.1 General This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b) 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 regulatory requirements. NOTE In this International Standard, the term “product” applies only to the product intended for, or required by ,a customer. 1.2 Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size ad product provided. Where any requirements(s) of this International Standard 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 this International Standard 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 regulatory requirements. 2 Normative reference The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 9000:2000, Quality management systems – Fundamentals and vocabulary. 3 Terms For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: supplier organization customer