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1.
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. 相似文献
2.
C. L. Burns 《Accreditation and quality assurance》1997,2(7):327-331
The accreditation procedure that the Department of Laboratory Sciences, CHPPM-Europe underwent is described. The laboratory
obtained ISO/IEC 25 accreditation through the American Association for Laboratory Accreditation (A2LA) and the Deutsches Akkreditierungssystem
Prüfwesen (DAP) as well as EN 45001 from DAP following the A2LA and DAP joint inspection. The accreditation process and the
importance of obtaining national and international accreditation are discussed.
Received: 30 May 1997 · Accepted: 16 June 1997 相似文献
3.
L. K. Isaev V. M. Lakhov Y. A. Karpov I. V. Boldyrev B. I. Paneva G. I. Fridman 《Accreditation and quality assurance》1999,4(5):169-173
The history and the present state of the national system for accreditation of analytical laboratories in Russia are described.
Received: 1 September 1998 / Accepted: 1 September 1998 相似文献
4.
A.M.H. van der Veen 《Accreditation and quality assurance》2002,7(1):2-6
The availability of certified reference materials, certified in accordance to the GUM is an important tool for the proper
estimation of measurement uncertainty in routine analysis. Many CRMs may suffer from incomplete or wrongly estimated uncertainties,
mainly due to lack of guidance on how to implement the GUM in the production of CRMs. In particular the inclusion of the impact
of inhomogeneity and instability in the uncertainty budget is often missing. The ongoing revision of ISO Guide 35 aims to
fill this gap in providing guidance how (batch) inhomogeneity and instability can be translated into measurement uncertainty.
The structure of the current ISO Guide 35 has been maintained as far as possible, but major parts underwent revision to become
better aligned with GUM and ISO Guide 34 (2000).
Received: 9 April 2001 Accepted: 22 October 2001 相似文献
5.
G. I. Ramendik 《Accreditation and quality assurance》1999,4(5):211-213
The structure and activities of a new accreditation body called the Russian Union of Measurement Accreditation Systems (RUMAS)
are briefly described. 相似文献
6.
P. Schmidt 《Accreditation and quality assurance》1999,4(4):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.
Received: 1 October 1998 · Accepted: 10 January 1999 相似文献
7.
A. Leclercq 《Accreditation and quality assurance》2002,7(7):299-304
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. 相似文献
8.
L. Fabry 《Accreditation and quality assurance》1996,1(3):99-108
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 相似文献
9.
J. Vogl C. R. Quétel M. Ostermann I. Papadakis L. Van Nevel P. D. P. Taylor 《Accreditation and quality assurance》2000,5(7):272-279
The present paper describes the contribution of the Institute for Reference Materials and Measurements to the certification
of B, Cd, Mg, Pb, Rb, Sr, and U amount contents in a natural water sample, in round 9 of the International Measurement Evaluation
Programme (IMEP-9). The analytical procedure to establish the reference values for B, Cd, Mg, Pb, Rb, Sr, and U amount contents
was based on isotope dilution inductively coupled plasma-mass spectrometry used as a primary method of measurement. Applying
this procedure reference values, traceable to the SI, were obtained for the natural water sample of IMEP-9. For each of the
certified amount contents presented here a total uncertainty budget was calculated using the method of propagation of uncertainties
according to ISO and EURACHEM guidelines. The measurement procedures, as well as the uncertainty calculations are described
for all seven elements mentioned above. In order to keep the whole certification process transparent and so traceable, the
preparations of various reagents and materials as well as the sample treatment and blending, the measurements themselves,
and finally the data treatment are described in detail. Explanations focus on Pb as a representative example. The total uncertainties
(relative) obtained were less than 2% for all investigated elements at amount contents in the pmol/kg up to the high μmol/kg
range, corresponding to low μg/kg and mg/kg levels.
Received: 21 October 1999 / Accepted: 29 January 2000 相似文献
10.
M. Plebani 《Accreditation and quality assurance》1999,4(3):84-86
The transition from quality assurance of the analytical phase to the quality management of total testing in clinical laboratories
is still at an early stage. But it has begun. Accreditation through voluntary, educational and professional schemes, like
the Clinical Pathology Accreditation scheme, is a useful tool for following defined standards of practice and having these
independently confirmed on the basis of a peer review. Approved clinical laboratories can obtain a hallmark of performance
and offer reassurance to users of their services. However, accreditation does not guarantee an error-free service; it is not
the final step, but an important stage in the improvement process. Quality is a journey and continuous quality improvement
is the paradigm for better addressing our efforts to satisfy customers' expectations for the desired health outcomes related
to a high-quality laboratory service. 相似文献
11.
Many certified reference materials are needed to calibrate and control analytical measurement processes in integrated steel
works. It is beyond the scope and capacity of most national laboratories to supply all of these needs. Yet, the demand for
these materials is steadily increasing as more steel producers update their quality systems in preparation for ISO 9000 registration
and/or ISO Guide 25 laboratory accreditation assessments. This paper describes how the Bethlehem Steel Corporation updated
its reference materials program to meet its internal needs and offers a model for use by others in improving their programs.
Received: 22 April 1998 · Accepted: 12 May 1998 相似文献
12.
R. Mathur-De Vré 《Accreditation and quality assurance》2000,5(1):3-10
The article analyses the scope and limitations of quality systems for research centres in the light of the problems involved,
foreseen advantages, and growing need created in the context of the globalisation phenomenon. Some propositions are put forward
concerning the development of possible quality assurance strategies for research activities.
Received: 30 June 1999 / Accepted: 24 September 1999 相似文献
13.
The methodology of evaluating the performance of sampling, sample preparation, and subsampling is reviewed. The requirements
to be set for a successful experiment are revisited. The central role of the reference method is explained, and so is the
choice of the parameters and the measurement methods. Based on the principles of the "Guide to the expression of uncertainty
in measurement" (GUM), a statistical model is developed that demonstrates the influence of the experimental design on the
outcome of the assessment experiment. This relationship is often overlooked in practice, as it is hardly mentioned in written
standards dealing with this kind of quality assessments. The statistical framework thus developed covers the statistical procedures
commonly appearing in written standards. Finally, the issue of testing the significance of the bias obtained from the experiment
is discussed.
Received: 14 June 1997 · Accepted: 2 September 1997 相似文献
14.
P. Vermaercke 《Accreditation and quality assurance》2000,5(1):11-15
Quality has always been one of the key issues in laboratories in general and formal quality assurance (QA) in testing laboratories has gained popularity over the last decade. However, the implementation QA in research and development (R&;D) laboratories is still the domain of a few pioneers. We can even ask whether a QA system in research makes sense at all and if such a system really provides any added value? Difficulties with respect to the implementation of such a system are mainly associated with the nature of the research process itself. However, it is obvious that QA offers clear advantages in R&;D, if some critical success factors have been taken into account. An important issue is the selection of a good QA standard for R&;D. This is certainly not an easy task, since there are no specific standards. Fortunately, some useful international guides have been published recently. 相似文献
15.
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 相似文献
16.
Rahim Hekmatshoar Majid M. Heravi Yahya S. Beheshtiha Farnoosh Faridbod 《Monatshefte für Chemie / Chemical Monthly》2002,133(2):195-197
Summary. 1,2-Diketones were readily converted to α-hydroxy ketones in high to excellent yields using zinc in saturated ammonium chloride
solution.
Received June 7, 2001. Accepted (revised) August 7, 2001 相似文献
17.
H. M. J. Goldschmidt N. C. V. Péquériaux J. De Jongh-Leuvenink 《Accreditation and quality assurance》2002,7(11):468-472
The European Foundation for Quality Management (EFQM) integral quality management model covers nine issues: five so-called
enabler criteria and four so-called result-oriented criteria. The first enabler criterion concerns leadership and covers all
kind of strategic management aspects. However, directly or indirectly, the leadership of the board of directors or its individual
members is characterized and scored. An even more explicate technique, originated in a totally different way, is the 360°
feedback evaluation method. In this paper both methods are compared and practiced on various individuals. A checklist was
developed to facilitate scoring in the EFQM leadership submodel. Both methods, although from a different origin, could be
linked easily, covered very similar aspects and gave results that were in excellent agreement with each other. The scoring
showed almost identical results, supporting in large the use of the integral EFQM model.
Received: 25 May 2002 Accepted: 17 July 2002
Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium
Correspondence to H. M. J. Goldschmidt 相似文献
18.
Mahmure Ü. Özgür Güzin Alpdoğan Bürge Aşçi 《Monatshefte für Chemie / Chemical Monthly》2002,133(2):219-223
Summary. A simple and rapid derivative spectrophotometric assay procedure is described for the analysis of caffeine (1), acetaminophen (2), and propyphenazone (3) in tablet formulations. The concentration range of application is 5.0–25.0 μg·cm−3 for 2 and 3 and 1.0–5.0 μg·cm−3 for 1. The method involves the extraction of the drugs from tablets with 0.1 N H2SO4, filtration, appropriate dilution, and measurement of the fourth derivative absorbance values at zero crossing wavelengths
of 230.0, 263.2, and 256.6 nm for 1, 2, and 3. As a reference method, a reversed phase HPLC procedure was developed. Commercially available tablets were analyzed; statistical
comparison of the results with those obtained from the reference method showed good agreement. The derivative spectrophotometric
method has the advantage of being simple, rapid, inexpensive, and easy to perform.
Received April 18, 2001. Accepted (revised) June 5, 2001 相似文献
19.
Addition–elimination reactions involving a nucleophile and a remote leaving group [SH
N(AE)tele] are well-known under basic conditions, especially amongst electron-poor six-membered heterocycles, but are less commonly
encountered for five-membered heterocycles and are rare under acidic conditions. Concentrated HCl converts 1-hydroxy-1H-pyrazolo[3,4-c] isoquinoline and 1-hydroxy-1H-pyrazolo[3,4-c]quinoline into 3-chloro-1H-pyrazolo[3,4-c]isoquinoline and 3-chloro-1H-pyrazolo[3,4-c]quinoline, respectively. However, apparently neither the isomeric 1-hydroxy-1H-pyrazolo[4,3-c](iso)-quinolines nor the parent 1-hydroxypyrazole undergo this reaction. Additionally, all these systems are refractory under
basic conditions. We present a plausible mechanism for the reaction, involving the 3-addition of Cl- to the diprotonated heterocycle, followed by the elimination of water. Calculations of the initial transition states and
intermediates, using optimisation at B3LYP/6-311+G(d,p), including thermochemistry [HF/6-31+G(d)], and single-point Poisson–Boltzmann
self-consistent reaction field determination of the free energy of solvation (Jaguar Poisson–Boltzmann self-consistent reaction
field), support this mechanism and reproduce the observed order of reactivity, the addition step being 2–4 kcal less favourable
for the isomeric 1-hydroxy-1H-pyrazolo[4,3-c](iso)quinolines and provide a rationalisation for the role of strong acid.
Received: 27 June 2002 / Accepted: 6 September 2002 /
Published online: 14 February 2003 相似文献
20.
Epoxidation of cyclooctene and other alkenes with Oxone® was promoted effectively in an aqueous micellar solution of an amphiphilic ketone, which was easily derived from hepta(ethylene glycol) monodecyl ether. 相似文献