共查询到20条相似文献,搜索用时 15 毫秒
1.
Although it seems self-evident that proficiency testing (PT) and accreditation can be expected to improve quality, their relative benefits remain uncertain as does their efficacy. The study reported here examines the following issues: (a) Why do laboratories take part in PT schemes? (b) How does participation in PT fit in with a laboratory's overall quality assurance (QA) system? (c) Is there a link between a laboratory's performance in specific PT and it's QA system? (d) How does PT performance change with time and how do laboratories respond to poor performance? The overall conclusion is that there is no evidence from the present study that laboratories with third-party assessment (accreditation and certification) perform any better in PT than laboratories without. The validity of this conclusion and its significance for the future design and operation of such schemes requires further investigation. In particular, study is required of the degree to which good performance in open PT correlates with blind PT performance, where laboratories are not aware that the samples being analysed are part of a quality assessment exercise. 相似文献
2.
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
3.
L. Huber 《Accreditation and quality assurance》1999,4(3):87-89
To help users of laboratory instrumentation to obtain laboratory accreditation and International Organization of Standardization
certification, instrument manufactures should develop a comprehensive compliance programme for their products that includes
product features, documentation and services for equipment validation and qualification.
Received: 5 October 1998 · Accepted: 20 October 1998 相似文献
4.
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
5.
H. C. Wallin 《Accreditation and quality assurance》1996,1(4):163-170
Most sophisticated products require testing for compliance with specifications and safety regulations before release into
many markets, and trade in many simpler commodities and products also requires supporting technical information. Test documentation
has become an essential element in this trade. Food intended for human consumption certainly falls into the "sophisticated
products" category. Lack of acceptance of laboratory test data across national borders may be a significant barrier to trade.
In order to avoid such barriers and unnecessary duplication of laboratory tests, mutual recognition of laboratory results
should be regarded as an important means of facilitating international trade in food products. It is difficult to envisage
recognition of test data across borders without internationally agreed criteria for assessing the competence of testing. These
criteria should, as a minimum, require that a laboratory involved in the analysis of foods operates a suitable quality system.
The laboratory must create a quality system appropriate to the type, range and volume of work performed. It is necessary for
the elements of this system to be documented in a quality manual which is available for use by the laboratory personnel. The
quality manual must be kept up-to-date by a person or persons having responsibility for quality assurance within the laboratory.
This paper describes and discusses the elements of a quality system in a food laboratory, including suitable quality assurance
measures, the use of validated analytical methods and participation in proficiency testing schemes.
Received: 24 February 1996 Accepted: 13 March 1996 相似文献
6.
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
7.
Robert George Visser 《Accreditation and quality assurance》1999,4(3):108-110
The Laboratory of the Government Chemist (UK) and the Institute for Reference Measurements and Materials (Belgium) evaluated
the correlation between accreditation and performance in proficiency tests. It was concluded that accreditation does not have
the expected positive effect on the quality of laboratory results. In this journal discussions conducted on this subject during
the CITAC workshop at Pittcon in 1998, were published. No satisfactory explanation for this phenomenon was put forward. In
this article, it is proposed that the main effect of accreditation is a decrease of intralaboratory spread. The effect on
the trueness of laboratory results is not significant due to the lack of certified reference materials and the low frequency
of participation in proficiency tests. Proficiency tests cannot be used to find a correlation between accreditation status
and quality without changing the set-up of the proficiency test. 相似文献
8.
R. F. Walker 《Accreditation and quality assurance》1999,4(8):360-365
The use of reference materials is the most pragmatic means by which the analyst can achieve comparability of data. Reference
material producers therefore need to have adequate quality systems in place for ensuring the reliability of their materials.
In order to provide guidance to both producers and assessors, ISO Guide 34 has recently been produced detailing the quality
system requirements for the production of reference materials. CITAC, REMCO and ILAC are now collaborating in the revision
of this guide to produce a free-standing document detailing the general requirements for the competence of reference material
producers. This paper discusses some of the more important issues described in these documents. The possible formation of
an international register containing details of a reference material producer's quality system status is also discussed. 相似文献
9.
Jane Beaumont 《Accreditation and quality assurance》1999,4(1-2):39-42
The requirements for establishing the competence of organisations involved in testing, calibration, certification and inspection,
and the criteria for their assessment and accreditation are specified in international guides and European standards. As these
guides and standards are intended for use by a range of organisations and accreditation bodies, operating in different disciplines,
they are written in general terms in order to be widely applicable. It follows that some interpretation of the requirements
is needed in order to address the different ways in which both organisations and accreditation bodies operate. This may be
seen by accredited organisations as providing an opportunity for accreditation bodies to 'change the goalposts'; the needs
of these organisations and of their clients must be accommodated as far as possible, without diminishing the value of, or
undermining confidence in, accreditation. The United Kingdom Accreditation Service has been listening to its customers, reviewing
its activities and is offering a more flexible pragmatic approach to assessment and accreditation; some of the new developments
are described. 相似文献
10.
Alex Williams 《Accreditation and quality assurance》1999,4(1-2):31-32
Laboratory accreditation is now well established and can justly claim to have had a beneficial impact on the quality of the
services provided by accredited laboratories. However, the needs of laboratories and their customers are continually evolving.
It is necessary for accreditation practices to keep abreast of these changing requirements if they are to continue to be of
benefit to laboratories and their customers. This paper gives a brief review of current accreditation practice and suggests
some changes that should be made to help laboratories meet the demands made on them by their customers.
Received: 2 July 1998 · Accepted: 3 August 1998 相似文献
11.
Maire Caitriona Walsh 《Accreditation and quality assurance》1999,4(8):365-368
ISO/IEC guide 25 is the internationally recognised base document for the accreditation of laboratories. Laboratory accreditation
is a system of peer assessment and a formal recognition that a laboratory is competent to perform specific tests or types
of tests ISO/IEC guide 25 plays a fundamental role in the life of the analytical chemist and is pivotal to the acceptance
of the philosophy "once tested everywhere accepted" and to ensuring the mutual acceptance of test data. Within the EU, the
attainment of accreditation to ISO/IEC guide 25 has become a way of life and it is now mandatory for laboratories engaged
in certain regulatory work areas. Guide 25 is currently under revision and over the past 2 years or so it has been the subject
of much debate among the calibration and testing community and it has engendered a considerable amount of written and oral
comments. The latest revision entitled "Draft International Standard ISO/IEC DIS 17025: General Requirements for the Competence
of Testing and Calibration Laboratories" was circulated to national standard organisations for their "comment and approval"
in mid 1998. Voting on this document commenced on 9 July and terminates on 9 December 1998. It is anticipated that a final
draft could be circulated in 1999. In accordance with the Vienna agreement this is a parallel ISO/CEN enquiry. This paper
will discuss the implications of the technical requirements of the current document for analytical chemistry with particular
emphasis on, the strengths, weaknesses and deficits inherent in the draft circulated in July 1998. 相似文献
12.
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
13.
Klaus Reber 《Accreditation and quality assurance》1999,4(4):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. 相似文献
14.
Clinical chemistry deals with measurements and observations using samples from patients in order to supply clinicians with
information to support their decisions in diagnosis and treatment. The discipline utilizes advanced chemical and biochemical
methods and also sophisticated instrumentation which allows a high throughput. Clinical chemistry has a long tradition of
quality assessment and improvement. The major tools have been proficiency testing or external quality assessment and internal
quality control. Nowadays, total quality management has become widely recognized, and accreditation according to international,
regional or national schemes has contributed to the design of quality systems and improvement of the reliability of results
from clinical laboratories. 相似文献
15.
16.
T. Ohtsubo 《Accreditation and quality assurance》1997,2(3):111-114
The background to the establishment of the Japan Accreditation Board for Conformity Assessment (JAB) is reviewed in relation
to the latest global developments in conformity assessment activities. JAB (known as the Japan Accreditation Board for Quality
System Registration at the time of its establishment) was established in 1993 as the accreditation body for quality system
registration, the focal point for conformity assessment in the private sector in Japan. The extension of the area of accreditation
was made in June 1996, covering all conformity assessment activities including laboratory accreditation, which resulted in
the amendment of the name of the body to the current one. Various elements of the laboratory accreditation program are introduced
to give the overview of this new program.
Received: 2 October 1996 Accepted: 5 December 1996 相似文献
17.
Manfred Golze 《Accreditation and quality assurance》2001,6(4-5):199-202
Since October 1998 the European Commission has financed a concerted action on Information System and Qualifying Criteria for
Proficiency Testing Schemes within the 4th framework program. As a major result of this project EPTIS, the European Information
System on Proficiency Testing Schemes which is available on the Internet since March 2000, is presented in this paper. Today
EPTIS contains comprehensive information on approximately 640 proficiency testing schemes from 16 European countries providing
information on the state of the art in proficiency testing in Europe. Finally some possible approaches for interlinkages and
recognition of proficiency testing schemes are discussed. 相似文献
18.
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
19.
Keith W. Davies 《Accreditation and quality assurance》1999,4(1-2):18-26
Since the mid-1960s quality assurance in clinical chemistry has progressed from a need to define and improve precision and
accuracy in analytical test procedures to an all-embracing process of assuring that the whole process of pre-analytical, analytical
and post-analytical phases of handling patient samples is managed effectively and efficiently. Automated and computer-controlled
equipment has reduced many of the analytical errors, in particular in imprecision, that were present in manual analysis. New
management techniques have been developed to control the quality and appropriateness of results. Developments in internal
quality control and external quality assessment procedures have enabled laboratories to continually improve the quality of
assays. Laboratory accreditation and external quality assessment scheme accreditation have ensured that peer review and peer
pressure have been applied to both laboratory and external quality assessment scheme performance. As the NHS reviews its priorities
and places more emphasis on primary care provider demands, hospital laboratories will of necessity assist with near patient
testing outside the laboratory. This will provide new challenges to the quality of the service provided.
Received: 2 July 1998 · Accepted: 1 August 1998 相似文献
20.
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