最高管理者、技术管理层和质量主管在国家实验室认可中各担负哪些 发布时间: 2012-01-27 19:53 点击:

最高管理者、技术管理层和质量主管在国家实验室认可中各担负哪些职责?
Top management, technology management and the quality manager at the National Laboratory Accreditation in the shoulder on which the duty?
 一般情况下,最高管理者、技术管理层和质量主管构成了实验室的最高管理层。最高管理层通常界定为:领导实验室贯彻执行上级有关方针政策,传达满足法律、法规、规范和顾客要求的重要性;主持策划、建立(含变更)质量管理体系即确定组织结构和管理结构,实施质量管理体系评审;制定质量方针目标,批准《质量手册》,发布质量承诺;任命关键岗位管理人员,指定关键岗位代理人;确保获得检测/校准所必要的资源等。如质量体系中的首席执行者、管理评审中的执行管理层都是最高管理者。
In general, top management, technology management and the quality manager, constitute the laboratory management. Top management is usually defined as: Leadership Laboratory implementation of higher-level relevant policies, laws and regulations, convey meet standard and customer requirements importance; presided over the planning, building (including change) quality management system to determine the organizational structure and management structure, the implementation of quality management system audit; establishing the quality policy objectives, approved the" quality manual", released quality commitment; appointment of key management positions, the specified key positions agents; ensuring access to testing and calibration is necessary resources. Such as quality system the chief executives, management review of the executive management team are top management.
 认可准则4.1.5h)和i)分别对技术管理层和质量主管的作用作了阐述:“技术管理层,全面负责技术运作和确保实验室运作质量所需的资源”;“指定一名人员作为质量主管,不管现有的其他职责,应赋予其在任何时候都能保证质量体系得到实施和遵循的责任和权利。质量主管应有直接渠道接触决定实验室政策和资源的最高管理层。
Accreditation Criteria of 4.1.5h ) and I ) respectively on the technical management and the quality manager, explains:" the role of technical management, has overall responsibility for the technical operations and ensure the quality of laboratory operations required resources";" the appointment of a staff as quality supervisor, regardless of other existing duties, should be entrusted to it at any time quality assurance system is implemented and followed the responsibility and rights. Quality supervisor should direct access decision laboratory policy and resource management.
 一般认为,对检测/校准技术方面可能存在问题的分析判断,校准/检测方法的最终确认,以及确保检测/校准工作质量所需技术资源的供应、调配等由技术管理层负责。也就是说,影响检测/校准质量的供应品、试剂和消耗材料的采购应由技术管理层负责。
Generally, for testing / calibration technology problems of analysis, calibration / test method for final confirmation, and ensure the quality of testing / calibration technology required resources supply, such as the deployment of the technology management is responsible for. That is to say, impact testing / calibration quality supplies, reagents and consumable materials procurement by the technical management is responsible for.
 内部审核及质量活动的管理,如体系运行过程中实验室人员未遵守质量手册或程序文件规定的处置、内审员管理等则由质量主管负责。大体而言,技术管理层通过对专业技术问题的处理和把握,从有效性方面确保检测/校准质量;质量主管则是通过对质量管理体系的运行和维护,从持续改进方面来保证检测/校准质量。
Internal audit and quality management, such as system operation process in laboratory personnel did not comply with the quality manual and procedure of disposal, internal audit management by quality supervisor. Generally speaking, technical management through to the professional and technical issues in the treatment and control, effectively ensure the quality of testing / calibration; quality supervisor is through to the quality management system operation and maintenance, from continuous improvement to ensure the quality of testing and calibration.