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1.
The complexity of different quality standards can, in principle, be covered by different approaches and strategies. In-depth
process mapping of quality control (QC) work streams was used by the analytical laboratories of Lonza AG to show up the principle
differences in being compliant to different quality systems. The results identified two main drivers for all necessary actions:
process-related activities and infrastructure-related activities. In addition, a clear indication of the economic impact of
these driving forces was gained, which led the laboratories to decide on a process-oriented approach. This approach has the
advantage of being able to reflect the different demands of different quality assurance (QA) regulations within the same QC
organizational structure. Following the process helps avoid unnecessary efforts in analytical work and represents a very economical
approach, at the same time, providing high flexibility to react to different QA or customer demands.
Received: 5 July 2002 Accepted: 12 November 2002
Acknowledgements The process-oriented approach resulted from many, very challenging discussions for which I would like to thank the staff
of my organization (Analytics & QC), especially, the QA staff and the LIMS team.
Presented at Analytica Conference, 23–26 April 2002, Munich, Germany
Correspondence to B. Ciommer 相似文献
2.
Margaret M. Robins S. Jane Scarll Pauline E. Key 《Accreditation and quality assurance》2006,11(5):214-223
During the last decade, it has become increasingly important that researchers demonstrate that research is conducted to the highest standards. The implementation of quality assurance for research laboratories will enable all fields of research and development to be judged impartially. There are no specific standards for research laboratories but where possible, existing standards can be adapted. This review is structured around two approaches. The first considers research to be a logical extension of testing, and it is assumed that testing standards can be applied methodically to each step in a research project. The second advocates a flexible approach, with research-specific criteria for assessing quality. The important papers published on this topic have been reviewed. The conclusions are that the general quality management approach, encompassed by the ISO 9000 series of standards with the emphasis on customer satisfaction and ‘fitness for purpose’, is suitable for implementing quality assurance in research laboratories. 相似文献
3.
A. Ríos D. Barceló L. Buydens S. Cárdenas K. Heydorn B. Karlberg K. Klemm B. Lendl B. Milman B. Neidhart R. W. Stephany A. Townshend A. Zschunke M. Valcárcel 《Accreditation and quality assurance》2003,8(2):68-77
The European Commission has supported the G6MA-CT-2000–01012 project on ”Metrology of Qualitative Chemical Analysis” (MEQUALAN),
which was developed during 2000–2002. The final result is a document produced by a group of scientists with expertise in different
areas of chemical analysis, metrology and quality assurance. One important part of this document deals, therefore, with aspects
involved in analytical quality assurance of qualitative analysis. This article shows the main conclusions reported in the
document referring to the implementation of quality principles in qualitative analysis: traceability, reliability (uncertainty),
validation, and internal/external quality control for qualitative methods.
Received: 15 October 2002 Accepted: 20 October 2002
This paper is a summary of the Quality Assurance section included in the final report of the MEQUALAN project. The authors
of this paper correspond to the members of the MEQUALAN Consortium. One of them (K.H.) does not fully agree with some parts
of the text.
Correspondence to A. Ríos 相似文献
4.
The role of matrix reference materials in the process of demonstrating the degree of equivalence of measurement results obtained
from intercomparisons is outlined, reviewing exemplary selected experience gained at BAM regarding the determination of organic
contaminants in environmental matrices.
The specific characteristics of reference materials employed in the process of demonstrating equivalence between laboratories
in the course of proficiency testing as well as the development, comparison and validation of methods are elaborated. The
demand is for series of appropriately characterised samples which are fit for the purpose and it is seen from representative
examples that the utilisation of such tailor-made RM designed to tackle the specific need of an analytical problem dominates
over certified matrix reference materials in this context. Concluding, the role of certified matrix reference materials in
quality assurance is briefly looked at both from the user’s and providers’ points of view.
Received: 9 September 2002 Accepted: 16 December 2002
Presented at CERMM-3, Central European Reference Materials and Measurements Conference: The function of reference materials
in the measurement process, May 30–June 1, 2002, Rogaška Slatina, Slovenia
Correspondence to R. Becker 相似文献
5.
W. Jäger 《Accreditation and quality assurance》1997,2(4):199-202
The necessity for analytical quality assurance is primarily a feature of the analytical process itself. With the full establishment
of the EU domestic market, it is also becoming a legal necessity for an increasing number of analytical laboratories. The
requirements which laboratories will need to fulfil are stipulated in DIN EN 45 001. Accredited testing laboratories must
in fact provide evidence that they work solely in accordance with this standard. National and EU commissions, which are legislative
authorities, tend therefore to specify analytical methods, e.g. in the form of regulations or appendices thereto, intended
to ensure that results from different laboratories will be comparable and hence will stand up in a court of law. The analytical
quality assurance system (AQS), introduced by the Baden-Württemberg Ministry for the Environment in 1984, obliges laboratories
to regularly participate in collaborative studies and thereby demonstrate their ability to provide suitably accurate analyses.
This alone, however, does not sufficiently demonstrate the competence of a laboratory. Only personal appraisal of the laboratory
by an auditor, together with the successful analysis of a sample provided by the same and performed under his observation,
can provide proof of the competence of the laboratory. From an analytical point of view, the competence of a laboratory must
be regarded as the decisive factor. Competence can only be attained through analytical quality assurance, which thus must
be demanded of all laboratories.
Received: 4 October 1996 Accepted: 15 January 1997 相似文献
6.
H. Hey 《Accreditation and quality assurance》1998,3(5):211-214
In order to ensure food consumer protection as well as to avoid barriers to trade and unnecessary duplications of laboratory
tests and to gain mutual recognition of results of analyses, the quality of laboratories and test results has to be guaranteed.
For this purpose, the EC Council and the Commission have introducedprovisions
– on measures for quality assurance for official laboratories concerning the analyses of foodstuffs on the one hand and animals
and fresh meat on the other,
– on the validation of test methods to obtain results of sufficient accuracy.
This article deals with legal requirements in the European Union on basic principles of laboratory quality assurance for official
notification to the EC Commission and on method validation concerning official laboratories. Widespread discussions and activities
on measurement uncertainty are in progress, and the European validation standards for official purposes may serve as a basis
for world-wide efforts on quality harmonization of analytical results. Although much time has already been spent, definitions
and requirements have to be revised and further additions have to be made. 相似文献
7.
Dermot Hayes 《Accreditation and quality assurance》1996,1(1):18-23
The pertinent issues necessary for the establishment of quality assurance in the microbiology laboratory are discussed. Quality
assurance is a planned system of control measures that enables management to ensure that the analytical data produced in the
laboratory are valid. To introduce quality assurance, all activities in the laboratory that affect the production of analytical
data must be documented and controlled. These include sampling, method selection, laboratory environment, equipment, reagents
and media, staff, reference materials and internal and external quality control. Laboratory accrediation in accordance with
EN45001 and ISO Guide 25 enables laboratories demonstrate to an external agency their ability to perform analytical work and
produce valid analytical data. This gives creditability to the laboratory and allows management to have confidence in the
data produced.
Received: 6 June 1995 Accepted: 3 July 1995 相似文献
8.
Louwrens Erasmus Smit 《Accreditation and quality assurance》2002,7(10):409-411
High quality analysis of food involves a comprehensive process, which includes proper sampling, validated methodology, experienced
technical staff and the use of standard reference materials. Today there is more international emphasis not only on generating
food composition data but also on data quality and the main issue is that South African data should be internationally recognized
as acceptable and representative. Quality is multi-dimensional and should at least include aspects of accuracy, precision
and representativeness. A major step forward is that laboratories can apply for accreditation, which involves, inter alia,
documented, validated methodology, regular interlaboratory studies, the use of certified reference materials and the existence
of a sound quality system. The South African National Accreditation System (SANAS) is a regulatory body in South Africa, which
is internationally recognized. Assessment of laboratories against specific standards is performed regularly and laboratories
have to comply with certain managerial and technical requirements. Once a laboratory is accredited, ongoing validation and
verification of results as well as regular assessment ensure reliability of results and overall competency of the laboratory.
With a quality assurance programme in place, the reliability of results of the Irene laboratory is beyond doubt and nutrient
data could be included in food composition tables.
Received: 31 January 2002 Accepted: 4 February 2002
Correspondence to Louwrens Erasmus Smit 相似文献
9.
Jean-Claude Libeer 《Accreditation and quality assurance》2001,6(4-5):151-153
Medical laboratories have a long tradition of external quality assessment. Starting from pure quality control of laboratory
performances, most schemes have evolved to a powerful tool for improving quality of clinical outcome of results. External
quality assurance in medical laboratories not only includes laboratory performance evaluation, but also evaluation of method
performance, post-marked vigilance, training and help. In the future, the quality of programmes must further be improved by
accreditation of schemes and by using electronic data interchange.
Received: 9 December 2000 Accepted: 14 December 2000 相似文献
10.
Henry F. Steger 《Accreditation and quality assurance》2002,7(4):134-145
This paper looks back on a quarter century of history of the Council Committee on Reference Materials of the International
Organization for Standardization – REMCO. It begins however with the period before its formation in 1976 to describe how the
Committee came into being as a response to a growing need by the analytical community for the number and variety of reference
materials (RMs) as well as a need for the assurance of the quality of RMs and ends with a view of REMCO activities in the
near future. This is not intended as a detailed history but instead to describe the evolution of REMCO by identifying major
activities and accomplishments of REMCO.
Received: 21 January 2002 Accepted: 22 January 2002 相似文献
11.
Robert Rej 《Accreditation and quality assurance》2002,7(8-9):335-340
Proficiency testing and external quality assurance of medical laboratories is now entering its sixth decade. These activities
comprise a broad range of applications including: providing participants and public health authorities with estimates of measurement
uncertainty and national infrastructure; providing education; provision of a practical basis for accreditation and regulatory
compliance. All branches of medical laboratory science have employed external quality assurance as a basis for improvement
and comparability. The opportunities and challenges reviewed here include: the proper establishment of multiple target values
in comparison to a system of traceability to reference or definitive methods; the problems of matrix effects and commutability
of patient and proficiency test samples; generating information on laboratory infrastructure and trends in analytical technique
and performance; providing education and setting goals for laboratory improvement; problems of specimen distribution; application
of Internet technology; the role of programs in legal mandates and accreditation.
Received: 24 April 2002 Accepted: 11 July 2002 相似文献
12.
Axel Colling Martyn Jeggo Helder Louvandini Mamadou Lelenta Mark Robinson 《Accreditation and quality assurance》2008,13(1):33-45
Quality systems, established to internationally accepted standards, are one mechanism that can assist in evaluations of the
sustainability of technology transfer, the proficiency of the user, and the reliability and comparability of data generated,
resulting in potential enhancement of laboratory credibility. The means of interpreting existing standards and implementing
quality systems in developing country veterinary diagnostic laboratories has become a significant adjunct to the technology
transfer element within the Food and Agriculture/ International Atomic Energy Agency, FAO/IAEA programme. The FAO/IAEA External
Quality Assurance Programme (EQAP) is given as an example for an initial step towards enhancing the “quality” culture in developing
country veterinary laboratories. In 1995 the EQAP began as an effort to assure that test results emanating from laboratories
using FAO/IAEA ELISA kits for animal disease diagnosis are valid. For this purpose 15 international external quality-assurance
rounds have been performed to date for a variety of animal diseases e.g. Rinderpest, brucellosis, trypanosomosis, and foot-and-mouth
disease (FMD). Results indicate that the EQAP is a valuable tool in the assessment of both the results provided by, and use
of the ELISA kits provided through, the joint FAO/IAEA programme. Furthermore EQAP can assist laboratory diagnosticians to
enhance quality control/quality assurance (QC/QA) procedures for conducting FAO/IAEA ELISAs and to advise on the implementation
of similar QC/QA procedures in other laboratory activities. Based on the experiences made during the implementation of the
EQAP a proposal for establishing a quality system standard was ratified through the World Organization for Animal Health (OIE)
general conference in May 2000. The OIE Standard On Management And Technical Requirements For Laboratories Conducting Tests
For Infectious Animal Diseases is based on ISO 17025 and provides a clear formula for establishing quality systems in veterinary
diagnostic laboratories world-wide. 相似文献
13.
M. Gardner Judith Dobson Brian Miller Colin Allchin David McMullan Trevor Oliver David Wells R. Hudson Richard Toft Mike Jessep 《Accreditation and quality assurance》2002,7(2):60-65
The implementation of a strategy for the assessment of the validity of environmental monitoring data – a ”data filter”– is
described. The approach was developed through the UK National Marine AQC Scheme for application to data collected during the
UK National Marine Monitoring Programme. Data reported for the year 1999, by nine laboratories, for 74 determinand-matrix
combinations were assessed on the basis of the completeness of their supporting quality assurance and quality control information.
The approach to the establishment of criteria of acceptability for quality information is described.
Received: 28 August 2001 Accepted: 29 November 2001 相似文献
14.
Joris Van Loco Maureen Moerenhout Hedwig Beernaert 《Accreditation and quality assurance》2003,8(2):61-67
A GLP study can be performed at more than one site. This is called a multi-site study. Although, the study is performed at
different sites, it is still one study and must completely comply with the GLP principles. The fact that different activities
are conducted at different sites implies that the planning, the organization and the communication are crucial for the success
of the study. This means that all the staff involved should know their responsibilities and should have the knowledge and
skills to realize all the phases of the study according to the GLP principles. To achieve a well managed multi-site study,
several strategies for setting up such a study can be followed. This paper focuses on the responsibilities, communication,
and collaboration of the personnel, which are involved in a multi-site study. Several case studies are highlighted, and we
concluded that the basic communication triangle in a single-site GLP study between test facility management, study director,
and the quality assurance unit should be extended to the communication among test facility and test site management, study
director, principle investigator(s), and the quality assurance units at the test sites.
Introduction
Received: 14 August 2002 Accepted: 26 November 2002 相似文献
15.
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
16.
F. De Corte 《Journal of Radioanalytical and Nuclear Chemistry》1998,234(1-2):9-16
Since its launching in the mid-70s, thek
0-standardization of NAA has been implemented and used in a growing number of laboratories worldwide. In the present paper,
a survey is given of the situation in Europe, where the method or its associated subroutines are now operational in 22 industrial,
governmental and university research centres spread over 12 countries plus IRMM of the European Union. In quite some of these
places, not only practical applications are going on, but — as also reported here — further developments of the methodology
are dealt with as well. These are related to such topics as the refinement of the fundamentals, the extension and improvement
of the nuclear data library, the calibration of the Gedetector and of the neutron irradiation facility, the care for quality
control/assurance and the upgrading of software for PC or mainframe. 相似文献
17.
18.
Irina Lutinger 《Accreditation and quality assurance》2002,7(11):494-497
As laboratories continue to downsize, commercialize and become more businesslike in today’s managed care environment, their
present and future success will greatly depend on the efficiency and flexibility of their laboratory information system (LIS).
Today, LIS is a primary tool for managing business and communication. Laboratories that hope to remain competitive in today’s
dynamic health care must continue to implement new and innovative approaches with their LISs.
Received: 26 July 2002 Accepted: 6 August 2002
Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium 相似文献
19.
M. Buzoianu 《Accreditation and quality assurance》2003,8(3-4):124-129
A lot of effort is being made in Romania to meet the present main strategic goal – EU integration. Since the confidence in
measurements is of considerable importance in almost every field of activity, the National Institute of Metrology (INM) is
involved in improving its calibration and measurement capabilities to provide services in accordance with the latest European
Regulation.
Within this framework the assurance of the required traceability of all measurements plays a most important role. As reliable
analytical measurements depend largely upon reference materials and the assurance of the traceability of amount measurements
is still developing in Romania, a new approach regarding the function of Certified Reference Materials (CRMs) may be emphasized.
The experience of the INM as well as new developments in Romania in preparation and certification of Reference Materials (RMs)
are described. A short review of the locally available RMs and CRMs is given. Some aspects regarding the use of RMs and CRMs,
especially for calibration, are discussed for their applicability for analytical measurements.
Received: 31 October 2002 Accepted: 24 January 2003
Presented at CERMM-3, Central European Reference Materials and Measurements Conference: The function of reference materials
in the measurement process, May 30–June 1, 2002, Rogaška Slatina, Slovenia
Correspondence to M. Buzoianu 相似文献
20.
Quality assurance in analytical measurement 总被引:2,自引:0,他引:2
The peculiarities of analytical measurement require to check characteristics of the error (its components) of the obtained
analysis results to assure the quality of the measurements. This article deals with the various quality assurance procedures
and algorithms which are used to check the quality indices, i.e. the accuracy, reproducibility, certainty and repeatability
of analytical measurements: These procedures include: laboratory rapid control; Intra-laboratory statistical control (statistical
selection control by alternative attribute, statistical selection control by quantity method of periodic check of the analysis
procedure for conformity to the specified requirements) and external control (inter-laboratory control checks, inter-laboratory
comparison tests, and intra-laboratory control algorithms carried out by the appropriate supervisory body.) in the separately
taken laboratory. The respective algorithms, control plans and control requirements, specified according to the different
control aims and assurance tasks, enable the quality and certianty of analytical information obtained in laboratories in Russia
to be assured.
Received: 9 November 1998 / Accepted: 24 November 1998 相似文献