【正文】 e 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 involvement of the top management are essential for developing and maintaining an effective and efficient quality management system to achieve benefits for interested parties. To achieve these benefits, it is necessary to establish, sustain and increase customer satisfaction. Top management should consider actions such as establishing a vision, policies and strategic objectives consistent with the purpose of the organization, leading the organization by example, in order to develop trust within its people, municating organizational direction and values regarding quality and the quality management system, participating in improvement projects, searching for new methods, solutions and products, obtaining feedback directly on the effectiveness and efficiency of the quality management system, identifying the product realization processes that provide added value to the organization. creating an environment that encourages the involvement and development of people, and provision of the structure and resources that are necessary to support the organization’s strategic plans.Top management should also define methods for measurement of the organization’s performance in order to determine whether planned objectives have been achieved.Methods include financial measurement, measurement of process performance throughout the organization, external measurement, such as benchmarking and thirdparty evaluation, assessment of the satisfaction of customers, people in the organization and other interested parties, assessment of the perceptions o customers and other interested parties of performance of products provided, and measurement of other success factors identified by management.Information derived from such measurements and assessments should also be considered as input to management review in order to ensure that continual improvement of the quality management system is the driver for performance improvement of the organization. Issues to be consideredWhen developing, implementing and managing the organization’s quality management system, management should consider the quality management principles outlined in . On the basis of these principles, top management should demonstrate leadership in, and mitment to, the following activities: understanding current and future customer needs ad expectations, in addition to requirements。 establishing continual improvement as an objective for processes of the organization