Internal audits in private medical laboratory practice – a Finnish experience in 1996–2000

Internal audits inherently effect quality improvement, and concrete results can be expected by careful planning. As audits should improve the quality system in situ, the development of audits should not be neglected. ISO/IEC 17025 describes the objectives of internal audits and management reviews in more detail compared to the former standards EN 45001 and ISO/IEC Guide 25, although the main features are unchanged. This addresses continuous surveillance of the current practice. A brief questionnaire on vertical audits was distributed to 74 of 120 employees at a Finnish private medical laboratory, Medix Laboratories Ltd. A positive feed-back was received from the current management of audits. However, the study revealed that continuous supervision of audits is needed. Many employees were not willing to perform audits if they had no previous experience. Additionally, audits performed at the workbench were not considered as the best possible for fruitful discussions. Received: 20 February 2001 Accepted: 30 November 2001     

Towards accreditation of clinical biochemistry in the public sector on the island of Mauritius

Medical laboratories of the public sector as well as of the private sector on the island of Mauritius are preparing for accreditation. The clinical laboratory of the Central Health laboratory of the Ministry of Health and Quality of Life has undergone a pre-assessment by experts of the International Atomic Energy Agency (IAEA) through the aegis of a project targeted to members of the Africa Region. Several shortcomings were identified and respective corrective actions were recommended for implementation within a given time frame. In addition to ensuring the competence of the laboratory, accreditation has various positive aspects such as an increased awareness of the staff to quality and better training opportunities. The pre-assessment exercise has provided a gap analysis, which is an important aspect in the preparation towards accreditation.     

Can the new ISO Guide 25/EN 45001 create better confidence in laboratory operations?

 Confidence in laboratory operations is discussed based on the ongoing revision of the ISO/IEC Guide 25. Confidence is a subjective attribute, which also depends on whose interest is considered. New and better-defined quality systems and technical elements will be included, and these are beneficial to the transparency of laboratory operations, as well as to the accreditation process. The ultimate aim is, of course, to satisfy customers. The testing laboratories' industrial customers are, however, generally unfamiliar with the ISO/IEC Guide 25 and accreditation. The main reason for improved confidence in testing and calibration laboratories is foreseen to come from closer interaction between laboratories and their customers.     

Certification of reference materials and accreditation of reference material producers: Questionable terminology leads to confusion

In the view of the Deutscher Kalibrierdienst (DKD) , a certifying body for reference materials can be considered to be a calibration laboratory. Therefore, accreditation of calibration laboratories in accordance with ISO/IEC 17025 is the most appropriate way to establish confidence in certificates for reference materials. If necessary, the criteria of ISO/IEC 17025 can be tailored to specific cases. There is no need to provide any new kind of reference-material specific accreditation. However, in view of the variety of reference materials and the practice existing in other countries, accreditation of testing laboratories and product certification bodies may optionally be acceptable as long as the same stringent principles with respect to traceability and measurement uncertainty are applied. Such accreditations but not accreditations of reference material producers (ISO Guide 34) are also covered by existing international mutual recognition arrangements (MRA).     

ISO/IEC 17025:2005《检测和校准实验室能力的通用要求》中存在的错误

本文就ISO/IEC17025《检测和校准实验室能力的通用要求》中存在的错误,提出看法。ISO/IEC17025:2005《检测和校准实验室能力的通用要求》对ISO/IEC17025:1999进行了修改和补充,使ISO/IEC17025进一步完善和提高,但笔者在学习过程中仍发现ISO/IEC17025标准中存在的一些错误,提出供实验室建立管理体系和实验室评审时参考。     

环境监测实验室管理系统的开发与应用

基于2005版《计量认证/审查认可(验收)评审准则》要求,为满足环境监测实验室业务流程而设计开发了信息管理系统。该系统主要用于环境监测实验室的资源管理和日常自动化办公。系统采用B/S架构,实现全球化办公运作,能对监测样品的受理、分发、分析、原始记录、监测报告、数据三级审核、报告签发实现全程自动流转,并运用工作流和智能表单设计实现实验室程序文件中各类程序和日常办公事务流程的执行;原始记录和监测报告全部实现自动归档及智能查询;同时根据2005版准则中的要求,对人员、设备、材料、环境要素、记录、质量控制等所有要素全面实施网络化管理。     

HFC网络设备管理系统标准与应用

日前,HFC网络设备管理系统国家标准已正式颁布实施,作者作为主要参加人参与了该标准的起草工作。本文阐述了规划建设统一、开放的HFC网络管理系统的必要性,介绍了国标与IEC国际标准的区别,并对国标在应用中需注意的关键技术问题进行了初步探讨。     

电击防护基础安全标准综述

依据IEC基础安全标准和出版物,概述了用于电子设备与电击防护有关的基础安全标准的主要内容,并把各个独立发布出版的标准中的内容有机地联系组合起来,形成一个较为系统和完整的电击防护理论体系。     

超高频RFID无线接口标准ISO／IEC 18000-6C的研究

继ISO／IEC 18000-6A、B之后的ISO／IEC 18000-6C,它对前两种模式的协议特点进行了一系列有效的修正与扩充。其中物理层数据编码、调制方式、防碰撞算法等一些关键技术有了改进,使得ISO／IEC 18000-6C的性能比A、B有了很大的提高。本文介绍了ISO／IEC 18000-6C标准的协议特点及其与A、B之间的比较。