iso iec17025 2005 如何利用ISO/IEC17025国家实验室认可提升技术
How to use the ISO IEC17025 2005 ISO / IEC17025 National Laboratory Accreditation and improving technology
ISO/IEC17025对实验室的技术要求,是为了保证实验室检测和校准的正确性和可靠性。在实验室活动中,影响正确性和可靠性的因素包括了人员、设施和环境条件、检测和校准方法及方法确认、测量的溯源性、抽样、检测和校准物品的处置等。LIMS作为一种综合性的实验室信息管理工具,应该对以上因素进行合理化的统筹管理。
ISO / IEC17025 on laboratory technical requirements, is to ensure that the laboratory testing and calibration correctness and reliability. In the laboratory activity, influence the correctness and reliability of the factors including the personnel, facilities and environmental condition, test and calibration methods and method validation, measurement traceability, sampling, handling of test and calibration items etc.. LIMS as an integrated laboratory information management tool, should be on the above factors are reasonable planning and management.
1、人员
In 1, staff
人员管理是实验室组织机构的体现,她不仅确定了人员在组织中的位置及相互关系,也明晰了所有人员的权利、责任和义务。ISO/IEC17025指出,管理层应授权专门人员进行特定类型的抽样、检测和/或校准、签发检测报告和校准证书、提出意见和解释以及操作特定类型的设备。实验室应保留所有技术人员(包括签约人员)的相关授权、能力、教育和专业资格、培训、技能和经验的记录,并包含授权和/或能力确认的日期。这些信息应易于获取。
Personnel management is the embodiment of laboratory organization, she not only defines the personnel in the organization's position and mutual relations, also know all their rights, responsibilities and obligations. ISO / IEC17025 pointed out, the management should be mandated specialized personnel to specific types of sampling, detection and / or calibration, issue test reports and calibration certificates, put forward opinions and interpretations and to operate particular types of equipment. The laboratory shall retain all the technical staff ( including contract personnel ) the relevant authorization, competence, educational and professional qualifications, training, skills and experience of the records, and contains the authorization and / or the ability to confirm the date. Such information should be easy to access.
LIMS 配备有专门的人员管理模块,将人员在组织中的行政关系对应到实验室信息管理中。除了描述人员的基本信息外,LIMS的一个重要作用是对人员的权利和责任作出明确的规定,这通常是用“角色”的方式实现的。所谓角色,是指在LIMS中的操作权限,哪些数据可以访问,哪些操作可以执行,都是通过角色来认定的。例如,“收样”是一种接收样品的角色,它只负责登录样品,而不能查看测试结果。根据实验室的人员配备,在保证流程合理、系统安全的前提下,我们可以给人员配置多重角色,以实现不同的管理需求。
LIMS are equipped with specialized staff management module, the personnel in the organization of administrative relationship corresponding to the laboratory information management. In addition to describing the basic information, LIMS is an important role for workers rights and responsibilities clearly defined, this is usually achieved by means of the" role". The so-called role, is defined in the LIMS operating authority, which data can be accessed, which operations can be performed, it is through the role of identification. For example," like" is a sample receiving part, it is only responsible for login samples, and can view test results. According to laboratory personnel, to ensure a reasonable flow, system security of the premise, we can give the staffing multiple roles, to achieve different management needs.
为了明确实验室人员的责任,LIMS通常对系统内发生的任何事件都会有详细的记录。从人员管理的角度来说,这不仅保证了对实验过程监督的管理要求,同时也确保了实验室的可回溯性。同时,由于LIMS详细记录了实验活动的全部过程,因此,对人员的业绩考核就成为LIMS非常擅长的事情。根据实验室考核的需要,LIMS能够从系统中方便地抽取关键绩效指标(KPI),并实时地做统计分析,为管理者提供实验室及其人员的最新的、动态的业绩全貌。这种能力对于传统的非LIMS管理模式来说是不可想象的。
In order to clear the responsibility of laboratory personnel, LIMS usually occur within the system in any event can have detailed records. From the management point of view, this is not only to ensure the experimental process supervision and management requirements, but also to ensure that the laboratory retrospective. At the same time, because the LIMS a detailed record of the experimental activities of the entire process, therefore, the personnel performance evaluation becomes LIMS very well. According to the laboratory assessment of needs, from the system LIMS can easily extract the key performance indicators ( KPI ), and real-time to do statistical analysis, for managers to provide laboratory and personnel of the new, dynamic performance view. This ability to the traditional LIMS management mode is inconceivable.
2、设施和环境条件
2, facilities and environmental conditions
实验室应确保其环境条件不会使结果无效,或对所要求的测量质量产生不良影响。在实验室固定设施以外的场所进行抽样、检测和/或校准时,应予特别注意。对影响检测和校准结果的设施和环境条件的技术要求应制定成文件。
iso iec17025 2005 如何利用ISO/IEC17025国家实验室认可提升技术
发布时间: 2011-12-23 01:50 点击:
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