1、Quality management system - RequirementScope11.1GeneralThis International Standard specifies requirements for a quality management system where an organizationneeds to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements,andaims to enhanc

2、e 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.A )B )NOTEIn this International Standard,the term “product”applies only to the produc

3、tintended for,or required by,a customer.Quality management system - Requirement1.2ApplicationAll 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 International

4、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 exclusion

5、s do not affect the organization s ability,or responsibility,to provide product that meets customer and applicable regulatory requirements.Quality management system - RequirementNormative reference2The following normative document contains provisions which,through reference in this text,constitute p

6、rovisions 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 no

7、rmative 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 management system

8、 - RequirementTerms and definitions3For 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:supplierorganizationcusto

9、merThe 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 “service”.Quality manage

10、ment system - Requirement4 Quality management system4.1 General requirementsThe 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.The organization shall

11、Identify the processes needed for the quality management system and theirapplication 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 processes are effective,Ens

12、ure the availability of resources and information necessary to support the operation and monitoring of these processesa)b)c)d)Quality management system - Requirementmonitor,measure and analyse these processes,andImplement actions necessary to achieve planned results and continual improvement of thes

13、e processes .e)f)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 control over such proce

14、sses.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.Quality managemen

15、t system - Requirement4.2Documentation requirements4.2.1 GeneralThe quality management system documentation shall includeDocumented statements of a quality policy and quality objectives, A quality manual,Documented procedures required by this International Standard,Documents needed by the organizati

16、on to ensure the effective planning,andRecords required by this International Standard(see 4.2.4)a)b)c)d)e)NOTE 1 Where the term “documented procedure”appears within this International Standard,this means that the procedure is established,documented,implemented and maintained.Quality management syst

17、em - RequirementNOTE 2The extent of the quality management system documentation can differfrom one organization to another due toThe size of organization and type of activities,The complexity of processes and their interactions, and The competence of personnel.a)b)c)NOTE 3The documentation can be in

18、 any form or type of medium.4.2.2 Quality manualThe organization shall establish and maintain a quality manual that includesThe scope of the quality management system,including details of and justification for any exclusions.(see 1.2),The documented procedures established for the quality management

19、system,or reference to them,andA description of the interaction between the processes of the quality management system.a)b)c)Quality management system - Requirement4.2.3 Control of documentsDocuments required by the quality management system shall be controlled.Records are a special type of document

20、 and shall be controlled according to the requirements given in 4.2.4A documented procedure shall be established to define the controls neededTo approve documents for adequacy prior to issue,To review and update as necessary and re-approve documents,To ensure that changes and the current revision st

21、atus of documents areidentified,kTo 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 controlled,andTo prevent the uni

22、ntended use of obsolete documents,and to apply suitable identification to them if they are retained for any purpose.a)b)c)d)e)f)g)Quality management system - Requirement4.2.4 Control of recordsRecords shall be established and maintained to provide evidence of conformity to requirements and of the ef

23、fective 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 records.Management resp

24、onsibility55.1 Management commitmentTop management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness byCommunicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,Establishing the quality policy,Ensurin