Forgot your password?
New user?
New Window Opens on the Secret Life of Microbes: Scientists Develop First Microbial Profiles of Ecosystems
CAS announces the release of SciFinder Scholar for Mac OS X
Press Releases
Press Releases
| Check out our New Publishers' Select for Free Articles |
Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.4, #4)
Assessment of limits of detection and quantitation using calculation of uncertainty in a new method for water determination by I. Kuselman; Felix Sherman (pp. 124-128).
An approach to the assessment of the limit of detection and the limit of quantitation using uncertainty calculation is discussed. The approach is based on the known evaluation of the limits of detection and quantitation as concentrations of the analyte equal to three and ten standard deviations of the blank response, respectively. It is shown that these values can be calculated as the analyte concentrations, for which relative expanded uncertainty achieves 66% and 20% of possible results of the analyte determination, correspondingly. For example, the calculation is performed for the validation of a new method for water determination in the presence of ene-diols or thiols, developed for analysis of chemical products, drugs or other materials which are unsuitable for direct Karl Fischer titration. A good conformity between calculated values and experimental validation data is observed.
Keywords: Key words Limit of detection; Limit of quantitation; Uncertainty of measurements; Analytical method validation; Water determination; Karl Fischer titration
Integrating accreditation, good laboratory practice and good manufacturing practice in an industrial analytical laboratory by P. Schmidt (pp. 129-132).
The Analytical Laboratory of BASF is a central service unit for chemical analysis which can be used by all departments within the company. It carries out routine as well as non-routine work and has a high amount of R&D orders. A quality system conforming with GMP rules was installed in the 1970s, followed by a GLP system about 6 years later. In 1995 an EN 45001 certificate was granted, which also stated the conformity with ISO 9002. A "types of test" orientated system was chosen for accreditation. This was better suited to the needs of a testing laboratory with a high amount of non-routine work than a purely test-procedure orientated accreditation. An integrated quality system has now been developed from these activities. It has partly common elements and partly differing elements taking into account specific regulations. For example, instrument calibration, staff training, validation of test procedures and the use of computerized systems are covered by uniform rules. Other elements such as handling of samples and report generation are arranged according to the individual requirements of the various standards. Rules and regulations are laid down in a system of documents which comprise the quality manual, general standard operating procedures (SOPs), laboratory-specific SOPs and test procedures. The quality system has been accepted by other accreditiation bodies on application of special accreditations (workplace safety, biodegradable polymers). But it has had no advantageous influence on getting GLP certification. An integrated system is very complex and requires appreciable resources. Management of processes and documentation can only be handled by extensive use of computers. Frequent training of staff and internal audits are necessary to keep the system at an acceptable level. In order to reduce the complexity of quality management regulations a harmonization of the different quality systems would be desirable.
Keywords: Key words Integrated quality management system; Accreditation according to EN 45001; Good laboratory practice; Good manufacturing practice; Laboratory for chemical analyses
Living with multiple standards – QA in a multidisciplinary laboratory by D. G. Holcombe (pp. 133-138).
The paper describes the experiences of a medium-sized analytical laboratory in implementing and developing a quality system compliant with several standards. The effect of the laboratory's changing role and work pattern on the quality system are considered. The laboratory costs are explored. The laboratory's particular experiences are shown to be consistent with recent market research in the United Kingdom. Some of the factors a laboratory needs to consider in formulating a quality strategy are described, including the possibility of joint assessments. Also, possible courses of development of the standards themselves are suggested. These developments could simplify the existing situation where laboratories are forced into a quality approach based on multiple standards and assessment.
Keywords: Keywords Quality assurance; Standards; Laboratory; Multidisciplinary
Practical experience of simultaneous accreditation and certification acquired in RIVM's official medicines control laboratories by G. M. Overvliet (pp. 139-142).
This article presents an overview of the practical experience acquired in two governmental medicines control laboratories in the Netherlands which combine the application of EN 45001 and ISO 9002 standards in the regulatory field of quality and risk assessment, and quality control of medicines and medical devices. This practical experience also includes simultaneous accreditation and certification. The EN 45001 standard was applied to laboratory testing activities and the ISO 9002 standard to non-laboratory file assessment activities as these activities are not covered by the scope of EN 45001. It appears that a combined application of these standards is practicable because they complement each other well. EN 45001 strongly emphasises technical competence. ISO 9002, on the contrary, emphasises more strongly the efficiency of the management processes and customer requirements.
Keywords: Key words Medicinal products; Market surveillance; Multiple accreditation and certification; Non-routine analysis; Desk research
A practical approach to metrology in chemistry and biology by M. Valcárcel; Angel Ríos; Eddie Maier (pp. 143-152).
The inherent difficulties of measurement in chemistry and biology have made it necessary to open discussion forums solely devoted to bench level work. This contribution summarises the conclusions of the Standards, Measurements and Testing Project (SMT4-CT96-6505) of the European Commission, devoted to the application of metrology in chemistry and biology. The objective of this project was to provide orientations and some recommendations which could partially satisfy end-users needs in the near future.
Metrological language in chemistry: New proposals versus "good old" terms
by R. Kadis (pp. 153-154).
Traceability in measurement – time for an update? by H. Steffen Peiser; Paul De Bièvre (pp. 154-155).
The present international definition of "traceability" is discussed and suggestions are made for a possible refinement of the definition.
Keywords: Key words Traceability; Metrology in chemistry; Vocabulary in metrology
A combination of accreditation and certification in an evolving process at EMPA: A management system to meet ISO 9001, ISO 14001 and EN 45001 by Klaus Reber (pp. 156-157).
The Swiss Federal Laboratories for Materials Testing and Research (EMPA) have established a quality assurance system based on EN 45001 which meets the requirements for accreditation of all EMPA's testing activities. As testing is only a part of EMPA's range of activities, and is performed in decentralised departments, the system does not satisfy the management needs. The fundamental reorganisation of EMPA's St. Gallen site was used as an opportunity to implement an overall process-oriented management system which also included quality and the needs for accreditation. Later, an environmental management system was added and then certified for ISO 9001 and 14001. The system consists of a "Management Manual" for the St. Gallen site and a customised "Quality Manual" for each department. One of the key elements is a comprehensive review and planning procedure covering all business aspects.
Keywords: Key words Certification; Accreditation; Quality; Management systems; Environmental management system; EMPA
Shared responsibility for metrology in chemistry
by W. Hässelbarth; Adolf Zschunke; Helene Felber; Bruno Wampfler (pp. 158-158).
Introduction of Japan Chemical Laboratory Accreditation by Yoichi Hiraga (pp. 162-162).
Japan Chemical Laboratory Accreditation (JCLA), a new accreditation body in chemical fields was established and the activities and organization of JCLA are outlined.
Keywords: Key words Accreditation; Laboratory; Chemical fields