A pilot experiment of joint assessments by accreditation and certification bodies in clinical laboratories

When the quality system of the health care organization is certified and the laboratory accredited, two different types of assessments are also performed. To reduce the extra work caused by these different assessments the Finnish Accreditation Service FINAS and SFS-Certification have made a pilot experiment in combining the assessments. Joint assessments have been a positive experience to the laboratory as well as to the assessing bodies, and we find this operating model worth developing.     

Reference materials in the Russian system of accreditation of analytical laboratories

 This article is devoted to the role of reference materials (RMs) in chemical analysis and their main applications in analytical laboratories. The principal requirements of the RMs used in accredited laboratories in the Russian Analytical Laboratories Accreditation System (SAAL) are presented. These include the basic regulatory and metrological requirements of RMs. Finally, a review of the provision of RMs used for the analytical control of various test objects is presented. Received: 9 August 1998 / Accepted: 9 November 1998     

Development of laboratory accreditation in the United States

 Laboratory accreditation in the United States is an old profession. Users and regulators have, it seems, been concerned about the quality of test data they obtain from laboratories for well over half a century. These users have developed many different systems to meet their needs. As a result, there is much duplication of effort and overlapping in accreditation requirements and many laboratories have to maintain current accreditation from a number of organizations. A number of attempts have been made over the years to reduce this duplication, but it still remains. In the meantime, rapid progress has been made internationally to recognize laboratory accreditation systems in different countries. This paper describes this situation and speculates on the future, considering the international thrust to simplify and consolidate conformity assessment procedures. Received: 26 May 1998 · Accepted: 6 June 1998     

Sense and nonsense of laboratory accreditation

 An open mind is essential for the implementation and improvement of total quality management. Leadership, as such, is of no value without a vision concerning corporate culture and human resources. Therefore, constant communication between partners within a corporate body is the cornerstone for empowerment. The evaluation of ideas and complaints is considered to be essential for the identification of strengths and weaknesses of a system, whereas, competition and benchmarking may reveal surprising opportunities for improvement. We discuss the idea that customer-oriented efficiency in a hospital environment may be classified as a critical success factor.     

Flexibilization of the scope of accreditation: an important asset for food and water microbiology laboratories

Beltest, the Belgian accreditation body, has investigated flexibilization of the scope of accreditation for chemistry laboratories and food and water microbiology laboratories. This flexibilization, synonymous with test-type accreditation, allows a laboratory to add new test methods or retry previous test methods without having to undergo a new audit by Beltest. It has been used for nearly ten years by German and Swiss accreditation bodies. Flexibilization permits the validation of methods and results, given that the competence of the particular laboratory is already well established. This new concept in microbiology allows client’s needs to be adequately met, and facilitates the quick establishment of a method in several laboratories at once in case of a public health crisis. The first laboratory to participate at this investigation on the flexibilization concept, as a test of the concept, was the Belgian reference laboratory for food microbiology.     

New policy in the accreditation of testing and calibration laboratories in Russia

 The structure and activities of a new accreditation body called the Russian Union of Measurement Accreditation Systems (RUMAS) are briefly described.     

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     

A combination of accreditation and certification in an evolving process at EMPA: A management system to meet ISO 9001, ISO 14001 and EN 45001

 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.     

Uncertainty calculations in the certification of reference materials

To serve as a measurement standard, a (certified) reference material must be stable. For this purpose, the material should undergo stability testing after it has been prepared. This paper looks at the statistical aspects of stability testing. Essentially, these studies can be described with analysis of variance statistics, including variant regression analysis. The latter is used in practice for both trend analysis and for the development of expressions for extrapolations. Extrapolation of stability data is briefly touched upon, as far as the combined standard uncertainty of the reference material is concerned. There are different options to validate the extrapolations made from initial stability studies, and some of them might influence the uncertainty of the reference material and/or the shelf-life. The latter is the more commonly observed consequence of what is called ’stability monitoring’. Received: 6 October 2000 Accepted: 4 December 2000     

The interpretation and use of stability data in the certification of reference materials

 Stability tests are carried out on candidate reference materials in order to ascertain that the certification values continue to be valid a reasonable time after completion of the certification analysis. These tests are also used for recommending storage conditions, as well as the duration of storage before certification values need be rechecked. BCR (Community Bureau of Reference) reference materials do not normally have an expiry date, but rely on stability monitoring throughout the lifetime of the certified material. The 1997 version of the BCR Guidelines for the production and certification of reference materials does, however, take into account the necessity of limiting the validity of a certification, when degradation of the material during storage cannot be ignored. This paper discusses an example of significant degradation taking place between the time of completion of the certification analysis and the issue of a formal certificate. Various options are presented together with an account of their influence on the certified values and their uncertainties. Received: 3 October 1997 · Accepted: 3 November 1997     

Qualification and validation of software and computer systems in laboratories

 Installation and operational qualification are important steps in the overall validation and qualification process for software and computer systems. This article guides users of such systems step by step through the installation and operational qualification procedures. It provides guidelines on what should be tested and documented during installation prior to routine use. The author also presents procedures for the qualification of software using chromatographic data systems and a network server for central archiving as examples. Received: 31 October 1997 · Accepted: 25 November 1997     

Qualification and validation of software and computer systems in laboratories

 Existing software and computer systems in laboratories require retrospective evaluation and validation if their initial validation was not formally documented. The key steps in this process are similar to those for the validation of new software and systems: user requirements and system specification, formal qualification, and procedures to ensure ongoing performance during routine operation. The main difference is that frequently qualification of an existing system is based primarily on reliable operation and proof of performance in the past rather than on qualification during development and installation. Received: 30 April 1998 · Accepted: 2 June 1998     

Qualification and validation of software and computer systems in laboratories

 Software and computer systems are tested during all development phases. The user requirements and functional specifications documents are reviewed by programmers and typical anticipated users. The design specifications are reviewed by peers in one to two day sessions and the source code is inspected by peers, if necessary. Finally, the function and performance of the system is tested by typical anticipated users outside the development department in a real laboratory environment. All development phases including test activities and the final release follow a well-documented procedure. Received: 17 May 1997 · Accepted: 30 June 1997     

Determination of Cd, Co, Cr, Cu, Fe, Ni and Pb in Milk, Cheese and Chocolate

 Combined analytical procedures consisting of wet digestion step followed by instrumental determination – differential pulse cathodic stripping voltammetry (DPCSV) or electrothermal atomic absorption spectrometry (ETAAS) – as well as a direct analysis method – slurry sampling ETAAS – for the determination of Cd, Co, Cr, Cu, Fe, Ni and Pb in milk, cheese and chocolate are described and compared. Wet digestion using a mixture of HNO₃-HClO₄-H₂O₂ is proposed for complete matrix decomposition prior to trace analyte determinati on by DPCSV or ETAAS. A mixture of HNO₃-H₂O₂ is used for slurry preparation. Optimal instrumental parameters for trace analyte measurements are presented. The reliability of the procedures has been verified by analyzing standard reference materials. Results obtained are in good agreement with the certified values and the relative standard deviations (for these results) are in the range 5–10% for wet digestion DPCSV or ETAAS and 3–9% for slurry sampling ETAAS in the range of 2 μgċg⁻¹ (Cd) to 12 μgċg⁻¹ (Fe). Received August 24, 1999. Revision January 20, 2000.     

The influence of experience on the quality of chemical measurements made on soils from former gasworks

 A strategy for ensuring that measurements of ten common contaminants found in soils from former gasworks are of optimum quality over long timescales is described. In particular, the performance of laboratories in applying validated measurement methods in both small- and large-scale inter-laboratory trials over a 5-year period is assessed. It is shown that a production engineering concept, the experience curve, has a significant influence on the quality of some of the measurements made and that this concept can be used to model the performance of laboratories. Complexity of the measurement procedure and familiarity of analysts with the measurement operations are suggested as the main drivers of method error. The implications of the achievable quality of measurement on the costs of land re-development and on confidence in the quality of the rejuvenated land are discussed. Received: 31 August 1996 Accepted: 5 February 1997     

Detection limits and quantitation limits in the view of international harmonization and the consequences for analytical laboratories

 In the literature and in daily work there exist many different models to describe detection limits and quantitation limits in the chemical measurement process (CMP). It is still an open question whether the evaluation of detection and quantitation limits should be an one-off process carried out during the validation of a CMP, or whether it should be a continuous process. Because of these reasons many laboratories have difficulties to interprete such values. It is necessary that the official standardization bodies should do some efforts in the international harmonization of the special standards concerning detection and quantitation limits. Received: 3 November 1997 · Accepted: 25 January 1998     

Trace analysis of microcontaminations in compliance with ISO 9001: monitoring and diagnostics in large-scale silicon manufacturing

 Severing principles are reported concerning the certification of and quality assurance in a trace-analysis laboratory that handles a large number of real samples, about 60 000 analyses/year with 50 validated methods. ISO 9001 emphasizes monitoring rather than diagnostics. For monitoring purposes the trace-analysis methods must be highly selective and of high precision, with high throughput and uptime within a justifiable economic framework in the analytical range of interest. All trace-analysis methods must be cross-checked using independent analytical tools. The analytical laboratory must be fully integrated in the total quality management of the plant. The analyst must know not only the performance of the trace-analysis tools but also the materials and processes involved in manufacturing. Received: 19 October 1995 Accepted: 15 November 1995     

Reference samples for analysis of gas impurities in aluminium and titanium alloys: Features of production, certification and usage to ensure traceability of results

 The current state of production, certification and use of standard samples of aluminium- and titanium-based alloys with specified contents of gas impurities is described. A list of the certified standard samples with a specified gas impurity content which are available in Russia is presented. Received: 20 October 1998 / Accepted: 9 November 1998     

The fundamental nature and role of the electrostatic potential in atoms and molecules

 A variety of atomic and molecular properties can be expressed in terms of the electrostatic potential. These include energies, covalent and anionic radii, electronegativities (chemical potentials) and a variety of properties that depend upon noncovalent interactons. We present a survey of such relationships, which may be exact or approximate; they may involve the potential in three-dimensional space, along the axes between bonded atoms, at nuclei or on molecular surfaces. Thus, the electrostatic potential, which is rigorously related to the electronic density by Poisson's equation, can be regarded as, effectively, another fundamental determinant of atomic and molecular properties. Received: 6 March 2002 / Accepted: 15 May 2002 / Published online: 29 July 2002