1、Quality management system - Requirement,Scope1.1 GeneralThis 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 ) aim
2、s 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
3、product intended for,or required by,a customer.,Quality management system - Requirement,1.2 ApplicationAll requirements of this International Standard are generic and are intended to be applicable to all organizations,regardless of type,size and product provided.Where any requirement(s) of this Inte
4、rnational 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
5、 exclusions do not affect the organization s ability,or responsibility,to provide product that meets customer and applicable regulatory requirements.,Quality management system - Requirement,Normative referenceThe following normative document contains provisions which,through reference in this text,c
6、onstitute 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 editio
7、n 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.,Quality manag
8、ement system - Requirement,Terms and definitionsFor 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 org
9、anization customer The term “organization”replaces the term “supplier”used in ISO 9001:9004,and refers to the unit to which this International Standard applies.Also,the term “subcontractor”. Throughout the text of this International Standard,wherever the term “product”occurs,it can also mean “servic
10、e”.,Quality management system - Requirement,4 Quality management system 4.1 General requirements The organization shall establish,document,implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.T
11、he organization shall Identify the processes needed for the quality management system and their application throughout the organization(see 1.2) Determine the sequence and interaction of these processes , Determine criteria and methods needed to ensure that both the operation and control of these pr
12、ocesses are effective, Ensure the availability of resources and information necessary to support the operation and monitoring of these processes,Quality management system - Requirement,monitor,measure and analyse these processes,and Implement actions necessary to achieve planned results and continua
13、l improvement of these processes . These processes shall bi managed by the organization in accordance with the requirements of this International Standard.Where an organization chooses to outsource any process that affects product conformity with the requirements ,the organization shall ensure contr
14、ol over such processes.Control of such outsourced processes shall be identified within the quality management system.NOTE Processes needed for the quality management system referred to above should include processes for management activities,provision of resources,product realization and measurement
15、.,Quality management system - Requirement,4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include Documented statements of a quality policy and quality objectives, A quality manual, Documented procedures required by this International Standard, Document
16、s needed by the organization to ensure the effective planning,and Records required by this International Standard(see 4.2.4)NOTE 1 Where the term “documented procedure”appears within this International Standard,this means that the procedure is established,documented,implemented and maintained.,Quali
17、ty management system - Requirement,NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to The size of organization and type of activities, The complexity of processes and their interactions, and The competence of personnel. NOTE 3 The docu
18、mentation can be in any form or type of medium.4.2.2 Quality manual The organization shall establish and maintain a quality manual that includes The scope of the quality management system,including details of and justification for any exclusions.(see 1.2), The documented procedures established for t
19、he quality management system,or reference to them,and A description of the interaction between the processes of the quality management system.,Quality management system - Requirement,4.2.3 Control of documents Documents required by the quality management system shall be controlled.Records are a spec
20、ial type of document and shall be controlled according to the requirements given in 4.2.4 A documented procedure shall be established to define the controls needed To approve documents for adequacy prior to issue, To review and update as necessary and re-approve documents, To ensure that changes and
21、 the current revision status of documents are identified,k To ensure that relevant versions of applicable documents are available at points of use, To ensure that documents remain legible and readily identifiable, To ensure that documents of external origin are identified and their distribution cont
22、rolled,and To prevent the unintended use of obsolete documents,and to apply suitable identification to them if they are retained for any purpose.,Quality management system - Requirement,4.2.4 Control of records Records shall be established and maintained to provide evidence of conformity to requirem
23、ents and of the effective operation of the quality management system.Records shall remain legible,readily identifiable and retrievable.A documented procedure shall be established to define the controls needed for the identification,storage,protection,retrieval,retention time and disposition of recor
24、ds.Management responsibility 5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by Communicating to the organization the importance of meeting customer as
25、 well as statutory and regulatory requirements, Establishing the quality policy, Ensuring that quality objectives are established,Quality management system - Requirement,d) Conducting management reviews,and e) Ensuring the availability of resources. 5.2 Customer focus Top management shall ensure tha
26、t customer requirements are determined and are met with the aim of enhancing customer satisfaction(see 7.2.1 and 8.2.1). 5.3 Quality policy Top management shall ensure that the quality policy Is appropriate to the purpose of the organization, Includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, Provides a framework for establishing and reviewing quality objectives, Is communicated and understood within the organization,and Is reviewed for continuing suitability.,Quality management system - Requirement,5.4 Planning,
