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1.
Research and development activities are carried out by various types of laboratories that are not the typical testing and
calibration laboratories for which the ISO/IEC 17025 is the quality assurance implementation reference. In this paper, such
laboratories engaged in R&D activities are classified and different approaches they can adopt with a view to implementing
a quality system that are suited to their characteristics and the type of work they conduct are proposed. These approaches
take account of existing standards for the certification/accreditation of laboratories and of guides on quality assurance
for non-routine analytical laboratories.
Received: 11 July 2002 Accepted: 29 November 2002
Presented at Analytica Conference, 23–26 April 2002, Munich, Germany
Correspondence to M. Valcárcel 相似文献
2.
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
3.
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
4.
J. L. Parr 《Accreditation and quality assurance》1998,3(9):376-378
There is currently no national program for recognition of United States environmental laboratories. This situation should
change sometime in 1998 as environmental testing laboratories should be able to apply for accreditation in the United States
via a system developed by the National Environmental Laboratory Accreditation Conference (NELAC). NELAC is an organization
whose purpose is to establish performance standards for accrediting environmental laboratories. Laboratories to be accredited
will be required to demonstrate qualifications of testing personnel, pass on-site inspections, perform satisfactorily on proficiency
test samples, and meet specified quality assurance standards. 相似文献
5.
Forensic examination results play an increasingly important role in bringing many criminal investigations to a successful
conclusion. The quality of the results of examinations performed in forensic science laboratories has always been the concern
of the individual forensic scientist. The interpretations and results are presented in court to non-experts. Therefore, it
is essential to ensure and maintain the highest standards of achievements and accuracy in forensic science. Many factors are
important contributors to quality assurance in forensic science. Some unique subjects affect not only the mode of inquiry
but also the way in which information is presented to the court, i.e. exhibits collection and sample handling, investigation,
examination techniques, report writing and court testimony. 相似文献
6.
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
7.
The quality assurance system (QASKI) developed and implemented in the National Institute of Chemistry is presented. It tries
to eliminate the incompatibilies between the present methods of quality assurance used in research and development institutes
such as good laboratory practice and accreditation. Since 1991, QASKI has been used for internal accreditation of laboratories
located in the institute, regardless of the fact that some of them deal with routine analyses and others with research and
development. Every laboratory that wishes to ensure the credibility of its research or routine work enters QASKI and at the
same time chooses an external method of approval. All interested laboratories, study directors, principal investigators, internal
auditing staff, heads of documentation, quality assurance unit staff, the Director of the institute and the Quality Management
Board participate in the internal system. 相似文献
8.
P. E. Holland Peter T. Woods Chris Brookes I. Uprichard Paul Quincey R. Robinson Hansa D'Souza Martin Milton Brian Goody William Bell Des Alphonso 《Accreditation and quality assurance》2001,6(3):120-129
The National Physical Laboratory (NPL) is involved in the dissemination of nationally traceable standards to which measurements
of air quality, occupational exposure and air pollution source emissions, and natural gas analyses, can be referenced. This
has required the development of national primary gas standards using absolute gravimetric and other techniques, and the development
of dynamic calibration techniques for gaseous species which would be unstable in high-pressure cylinders. The methodology
used for preparing gas standards gravimetrically is described, together with the rigorous quality assurance measurements and
consistency checks which are used to demonstrate their accuracy and stability. The uncertainty budget assigned to these standards
will also be summarised. NPL primary standards are used to certify traceable 'secondary' gas standards which are disseminated
so as to ensure the accuracy of gas analysis measurements. Examples of the applications of these secondary standards are presented.
The gas standards are employed in proficiency testing of industrial stack-testing organisations, and results of the initial
rounds are presented. NPL gas standards are also now being used as the basis of the United Kingdom Environment Agency's new
type-approval and certification scheme for continuous industrial stack-emission analysers. A recent important international
initiative, in the field of gas analyses, is the agreement by national standards laboratories across the world to demonstrate
the equivalence of their calibrations, by means of key comparisons between them. These worldwide key comparisons are complemented
in Europe through the EUROMET initiative which seeks to establish the equivalence and comparability of calibration standards
held at national standards laboratories across Europe. Examples of these intercomparisons are presented.
Received: 23 March 2000 / Accepted: 18 August 2000 相似文献
9.
R. Wood 《Accreditation and quality assurance》1996,1(4):140-149
The European Union has prescribed strict quality standards for official food laboratories and the methods of analysis to
be used in laboratories when carrying out official food control work. These requirements, which are based on accreditation,
participation in proficiency testing schemes and using validated methods of analysis, are described in detail. The similar
approach being taken within the Codex Alimentarius Commission is also outlined. The procedures prescribed will ensure that
official food control laboratories have in place the measures to ensure that consistently reliable data can be produced.
Received: 29 November 1995 Accepted: 8 January 1996 相似文献
10.
D. G. Holcombe 《Accreditation and quality assurance》1999,4(4):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.
Received: 1 October 1998 · Accepted: 26 January 1999 相似文献
11.
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
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.
The EURACHEM/CITAC Guide 2 is an important step towards the establishment of a quality assurance system in analytical research
and development. But it is only the first step because it focuses on the metrological characteristics. In addition to Guide
2 there should be a supplementary guide providing assistance for effective and quality-orientated management of research groups. 相似文献
14.
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
15.
N. P. Boley 《Accreditation and quality assurance》1999,4(8):347-349
Proficiency testing (PT) is being increasingly used as an important quality assurance tool for laboratories. The subject
of quality of the providers of PT schemes has been discussed increasingly in recent years. Some countries have implemented
systems for the accreditation of PT schemes. This paper looks at the background to the accreditation of PT schemes, the likely
mechanisms which could be employed for accreditation, and some of the practical aspects. 相似文献
16.
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
17.
Haim Hacham Nurit Tetro Salit Kochavi-Azolai Nava Stern Dana Mizrahi Anna Lisenker Emanuel Gazit 《Accreditation and quality assurance》2007,12(8):409-413
The Department of Public Health Laboratories consists of five major laboratories located across the country of Israel: four
environmental laboratories performing microbiological and chemical testing of food and water products [accredited according
to International Organization for Standardization (ISO) 17025 since 1999) and a fifth laboratory that is dedicated to virology
testing (certified according to ISO 9000 since 2003). Historically, each laboratory operated independently and developed its
own quality assurance (QA). On November 2004, an important strategic decision was made: to unify all five laboratories’ QA
systems conformed to ISO 17025, ISO 15189, and ISO 9000—a transition from five laboratories operating independently in the
field of QA toward establishing a multisite laboratory. This process was considered and visualized as a major organizational
change and therefore raised some resistance among both QA managers and the professional laboratories’ management. Thus, it
was necessary to overcome the resistance and at the same time induce thoughts of ways of reshaping and formatting the new
and uniform quality manual and uniform standard operating procedures (SOPs). In September 2005, the first phase of the process
was completed, and all four environmental public health laboratories successfully passed a reaccreditation audit using a uniform
QA manual guide and partially uniform SOPs. We shall share our experience and discuss the major contributions of this process
to overall laboratory management.
Presented at the 3rd International Conference on Metrology, November 2006, Tel Aviv, Israel. 相似文献
18.
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
19.
P. Bode K. Heydorn R. W. Innes R. Wood R. Zeisler 《Accreditation and quality assurance》1998,3(5):197-202
Laboratory managers are facing the task of altering the attitudes of themselves and their employees in order to implement
a quality lifestyle, which is the prerequisite for successful implementation of a quality system complying with appropriate
international standards. The alterations require a painstaking and constructive approach. Not all laboratories have the resources
to secure the assistance of quality consultants. For those laboratory managers who have to find their way towards quality
management on their own, some recommendations are given for a path towards a self-sustaining quality system. Several practical
aspects of the basic steps in this path, which starts with assessing the current status of the laboratory and is followed
by awareness building, are discussed. The recommendations are derived from the experience of the authors in their own laboratories.
Received: 5 June 1997 · Accepted: 7 December 1997 相似文献
20.
Besides their role as an external quality control tool, PT results or samples could be used as an alternative to fulfil some of the quality assurance requirements such as analytical precision, uncertainty assessment, and internal quality control. This additional use of proficiency testing could help laboratories to reduce the financial impact of their quality assurance process. The purpose of this paper is to highlight some practical uses of PT results or samples in the environmental analytical field, which have been implemented at ISSeP (Institut Scientifique de Service Public), either for method validation or for internal quality control.Presented at the Eurachem PT Workshop September 2005, Portorož, Slovenia 相似文献