【正文】 nternational, national ,regional and industry sector standards, relevant statutory and regulatory requirements,decisions by the organization, decisions by the organization, sources of external information relevant for the development of the organization’s petencies, and information about the needs and expectations of interested parties.The generation, use and control of documentation should be evaluated with respect to the effectiveness and efficiency of the organization against criteria such as functionality (such as speed of processing), user friendliness, resources needed, policies and objectives current and future requirements related to managing knowledge. benchmarking of documentation systems, and interfaces used by organization’s customers, suppliers and other interested parties.Access to documentation should be ensured for people in the organization and to other interested parties, based on the organization’s munication policy.ISO9001:2000, Quality management systems – Requirements Documentation requirements GeneralThe quality management system documentation shall includea) documented statements of a quality policy and quality objectives,b) a quality manual,c) documented procedures required by this International Standard,d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard.NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to a) the size of organization and type of activities,b) the plexity of processes and their interaction, and c) the petence of personnel.NOTE 3 The documentation can be in any form or type of medium. Quality manualThe organization shall establish and maintain a quality manual that includesa) the scope of the quality management system, including details of and justification for any exclusions,b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. Control of documentsDocumental required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in .A documented procedure shall be established to define the controls neededa) to approve documents for adequacy prior to issue,b) to review and update as necessary and reapprove documents,c) to ensure that changes and the current revision status of documents are identified,d) to ensure that relevant versions of applicable documents are available at points of use,e) to ensure that documents remain legible and readily identifiable,f) to ensure that documents of external origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained or any purpose. Control of recordsRecords shall be established and maintained to provide evidence of conformity to requirements 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, retention time and disposition of records. Use of quality management principlesTo lead and operate an organization successfully, it is necessary to manage it in a systematic and visible manner. The guidance to management offered in this International Standard is based on eight quality management principles. These principles have been developed for use by top management in order to lead the organization toward improved performance. These quality management principles are integrated in the contents of this International Standard and are listed belowa) Customer focusOrganizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.b) LeadershipLeaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can bee fully involved in achieving the organization’s objectives.c) Involvement of peoplePeople at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.d) Process approachA desired result is achieved more efficiently when activities and related resources are managed as a process.e) System approach to management Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.f) Continual improvementContinual improvement of the organization’s overall performance should be a permanent objective of the organization.g) Factual approach to decision makingEffective decisions are based o the analysis of data and information.h) Mutually beneficial supplier relationshipsAn organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.Successful use of the eight management principles by an organization will result in benefits to interested parties, such as improved monetary returns, the creation of value and increased stability.5 Management responsibility General guidance IntroductionLeadership, mitment and the active invol