Integration of parallel-operating quality systems

Since the 1980s, quality systems have become an essential element in successful companies and institutions. Today those systems are indispensable to fulfill the needs of the customers and last but not least the requirements of the society. Depending on the company's activities and fields of services, it is necessary to establish various quality systems. The Institut Fresenius (IF) Group runs a number of analytical laboratories and sampling groups. The whole group was accredited according to DIN EN 45001 in 1994. Good Laboratory Practice (GLP) was introduced in 1992 and was certified by the national authority. For certain customers, IF Group is also obliged to work according DIN EN ISO 9001 or GMP. A comparison of these systems with respect to their different priorities shows the possibility of integrating their rules into one comprehensive quality system. The IF Group has therefore installed a quality system operating in parallel. Multilocation accreditations and/or certifications are taking these efforts into account. The benefits are: high transparency of the system for the customers, auditors and personnel, a reduction of maintenance costs, and great flexibility to react to new standards. Could these activities lead to a new Integrated Management System?     

Certified sediment reference materials for trace element analysis from the National Metrology Institute of Japan (NMIJ)

Two types of sediment reference material (NMIJ 7302-a and 7303-a) for trace elements analysis have been prepared and certified by the National Metrology Institute of Japan in the National Institute of Advanced Industrial Science and Technology (NMIJ/AIST). The original materials were collected from a bay near industrial activity in Kyushu (NMIJ CRM 7302-a; marine sediment) and from Lake Biwa (NMIJ CRM 7303-a; lake sediment). The sediment materials were air-dried, sieved, homogenized, packaged in 1000 glass bottles (60 g each), and radiation sterilized. Certification of these CRM for trace elements was conducted by NMIJ, where each element was determined by at least two independent analytical techniques. Isotope-dilution inductively coupled plasma mass spectrometry (ICP–MS) was applied for certification of all the elements except mono-nuclide elements such as As and Co. Other techniques such as ICP–MS with quadrupole mass spectrometry and sector-field mass spectrometry, inductively coupled plasma atomic emission spectrometry (ICP–AES), and atomic absorption spectrometry (AAS), were also used. Certified values have been provided for 14 elements (Sb, As, Cd, Cr, Co, Cu, Pb, Hg, Mo, Ni, Se, Ag, Sn, and Zn) in both CRM.     

Uncertainty calculations in the certification of reference materials 4. Characterisation and certification

The main objective of the certification of a reference material is to determine its property values including their uncertainty. In the previous parts of this series, the basis for the evaluation of measurement uncertainty of the property values has been examined, including the conversion of homogeneity and stability study data into standard uncertainties. In this final part, the determination of the property values and the modelling of the certification process is discussed. It is noted that the characterisation of a reference material can be modelled in some cases using analysis of variance statistics, but a more generally applicable model can be developed based on χ²-fitting. Furthermore, it is concluded that there is an advantage in using absolute standard uncertainties instead of relative ones when modelling the certification process. Received: 14 October 2000 Accepted: 21 January 2001     

Quality management, certification and accreditation in medical laboratories – the view of ECLM

 Increasing demands from health care planners and industrialists conducting clinical trials, as well as general competition, are forcing medical laboratories to seek third-party recognition of their quality management systems. There is a tendency to move from certification of a laboratory director, via certification of the laboratory quality system (ISO 9000 family), to accreditation needing proof of professional and technical competence in laboratory tasks. The requirements of accreditation are presented in several national schemes and in the European Standards series (EN 45 000) and the International Organization for Standardization's guide, ISO/IEC 25, to be amalgamated soon. The latter system provides transnational recognition through participation of the accrediting bodies in the European co-operation for Accreditation. Necessary supplementary guidelines exist for chemical laboratories (Eurachem) and medical laboratories CEAC/ECLM). Traceability and reliability of results are obtained by utilizing a global reference examination system and by participating in transdisciplinary work. The costs of achieving accreditation are considerable and mainly involve the production of quality handbooks and written work procedures by personnel. The rewards are an open system, smoother work, emphasis on prevention of mistakes, and satisfied stakeholders. Received: 5 October 1998 · Accepted: 20 October 1998     

User impersonation in key certification schemes

In this note we exhibit some weaknesses in two key certification schemes. We show how a legitimate user can impersonate any other user in an ElGamal-based certification scheme, even if hashing is applied first. Furthermore, we show how anybody can impersonate users of the modular square root key certification scheme, if no hashing occurs before the certification. This shows that it is essential for this certification scheme to hash a message before signing it.     

一条质量效益之路：——记上海松江电子仪器厂

介绍了松江电子仪器厂通过引进人才，完善质保体系和售后服务，从一家小型村办企业发展为当地的明显企业的发展经验。     

信息技术设备、音视频设备强制性认证实施规则实施要求及修订解读

该文主要根据中国质量认证中心颁布的《电气电子产品类强制性认证实施规则信息技术设备》（编号：CNCA-01C-020：2010）和《电气电子产品类强制性认证实施规则音视频设备》（编号：CN-CA-01C-017：2010）及相关认证标准的的要求,结合自身在CQC认证工作中的一些经验,对新旧实施细则差异及实施要求作一解读。     

以质量求发展 向质量要效益

介绍了青岛海信电器公司在注重质量、提高效益上的一些成功的经验。     

电子信息类产品3C认证的EMC测试(下)

详细介绍了电子产品电磁兼容认证标准及相应的测量方法。     

电子信息类产品3C认证的EMC测试(上)

详细介绍电子产品电磁兼容认证标准及相应的测量方法