【正文】 ], are established at relevant functions and levels within the anization. The quality objectives shall be measurable and consistent with the quality policy. Quality management system planning Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in , as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Responsibility, authority and munication Responsibility and authority Top management shall ensure that responsibilities and authorities are defined and municated within the anization. Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, and C) ensuring the promotion of awareness of customer requirements throughout the anization. ANSI/ISO/ASQ Q90012020 5 NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. Internal munication Top management shall ensure that appropriate munication processes are established within the anization and that munication takes place regarding the effectiveness of the quality management system. Management review General Top management shall review the anization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained (see ). Review input The input to management review shall include information on a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) followup actions from previous management reviews, f) changes that could affect the quality management system, and g) remendations for improvement. Review output The output from the management review shall include any decisions and actions related to a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs. 6 Resource management Provision of resources The anization shall determine and provide the resources needed a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. ANSI/ISO/ASQ Q90012020 6 Human resources General Personnel performing work affecting product quality shall be petent on the basis of appropriate education, training, skills and experience. Competence, awareness and training The anization shall a) determine the necessary petence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience (see ). Infrastructure The anization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a) buildings, workspace and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport or munication). Work environment The anization shall determine and manage the work environment needed to achieve conformity to product requirements. 7 Product realization Planning of product realization The anization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see ). In planning product realization, the anization shall determine the following, as appropriate: a) quality objectives and requirements for the product。 b) the need to establish processes, documents, and provide resources specific to the product。 d) records needed to provide evidence that the realization processes and resulting product meet requirements (see ). The output of this planning shall be in a form suitable for the anization’s method of operations. ANSI/ISO/ASQ Q90012020 7 NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. NOTE 2 The anization may also apply the requirements given in to the development of product realization processes. Customerrelated processes Determination of requirements related to the product The anization shall determine a) requirements specified by the customer, including the requirements for delivery and postdelivery activities, b) requirements not stated by the customer but necessary for specified or intended use, where known, c) statutory and r