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1.
Since 1989 testing laboratories in Europe have had the possibility to confirm their competence in carrying out certain testing
procedures by means of accreditation. Over the years an independent European Accreditation system has been developed, which
many member states of the European Union have joined. The existing accreditation organizations joined to form the unified
organization EA (European Cooperation for Accreditation) in 1997. Members of this organization are, inter alia, one representative
of the accreditation authorities of each of the member states. The German accreditation system is different to the European
system in that it is split. Here, we differentiate between the sector established by law and that which is not. Both sectors,
however, pursue the same goal. Because of this double certification of competence and the resulting multiple reviews, German
testing laboratories face a considerably greater load in comparison to their European colleagues. Several authorities are
already working on the removal of this split accreditation system. The efforts must, however, be concentrated and brought
into line. Efforts by the DAP and DACH for flexible accreditation and the creation of a standardized registration authority
for testing laboratories in the field of workplace measures are examples of how the German accreditation system could develop
in the future. 相似文献
2.
Accreditation of medical laboratories is a well-established process in many parts of the world. We describe this process in
South Africa under the South African National Accreditation System. The elements of accreditation, the accreditation process
for medical laboratories and future prospects are outlined.
Received: 4 September 2000 Accepted: 24 April 2002 相似文献
3.
In South African industry there is a strong appreciation of Quality Assurance. More than 1400 companies have been certified
as complying with ISO 9000, and this, of course, has resulted in a strong demand for accredited calibration and test facilities.
Work on the development of a national calibration service started in 1976, and the South African National Calibration Service
(SANCS) was inaugurated in 1980 with 13 calibration laboratories. The early maturity of the SANCS can be judged by the fact
that by 1984 it had the technical capability to establish a mutual recognition agreement with a European country. It now has
a total of some 191 accredited laboratories, 139 calibration laboratories and 52 testing laboratories. In 1993, the SANCS
signed mutual recognition agreements with the CNLA (Taiwan) and the European Co-operation for the Accreditation of Laboratories
(EAL). In 1994 it entered the field of testing laboratory accreditation and is already experiencing a strong influence therefrom,
and in 1997 it changed its name to National Laboratory Accreditation Service (NLA). In May 1995, the NLA was appointed by
the Department of Trade and Industry to establish a South African National Accreditation System (SANAS). Progress with this
work up to the present time has been substantial. 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.
R. Dybkaer 《Accreditation and quality assurance》1999,4(3):90-92
Increasing demands from health care planners and industrialists conducting clinical trials, as well as general competition,
are forcing medical laboratories to seek third-party recognition of their quality management systems. There is a tendency
to move from certification of a laboratory director, via certification of the laboratory quality system (ISO 9000 family),
to accreditation needing proof of professional and technical competence in laboratory tasks. The requirements of accreditation
are presented in several national schemes and in the European Standards series (EN 45 000) and the International Organization
for Standardization's guide, ISO/IEC 25, to be amalgamated soon. The latter system provides transnational recognition through
participation of the accrediting bodies in the European co-operation for Accreditation. Necessary supplementary guidelines
exist for chemical laboratories (Eurachem) and medical laboratories CEAC/ECLM). Traceability and reliability of results are
obtained by utilizing a global reference examination system and by participating in transdisciplinary work. The costs of achieving
accreditation are considerable and mainly involve the production of quality handbooks and written work procedures by personnel.
The rewards are an open system, smoother work, emphasis on prevention of mistakes, and satisfied stakeholders.
Received: 5 October 1998 · Accepted: 20 October 1998 相似文献
6.
In response to the requirements of the "Global Approach" in Germany, a national accreditation system has been established
based on traditional experiences in the recognition of the competence of laboratories and certification bodies. In 1991, the
German Accreditation Council (DAR) was founded as a coordinating body supported by the Federal and State Ministries and German
industry. In this way, it was possible to organise coordinated representation in international bodies, to offer a forum for
cooperation between authorities and industry, and to provide for a structure subdivided into sectors which better fits the
needs of the industrial sectors and gives them the necessary transparency and acceptance. The DAR itself does not carry out
accreditations. This is done by the accreditation bodies represented in the DAR and specialised in for specific subjects,
thereby having a close connection with expert groups of a high technical competence in their specific technical fields. At
the end of this paper, the procedure for the assessment of the technical competence of a laboratory, an important part of
the accreditation, is described. 相似文献
7.
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
8.
Gurdeep Singh Dhatt David Burnett Sean Peters A. W. Van Rijswijk 《Accreditation and quality assurance》2005,10(6):295-299
Under the auspices of the South African National Accreditation System (SANAS) the South African medical laboratory accreditation programme was established in June 1999. This study reports the non-conformances identified during the assessment of 103 medical laboratories in South Africa between September 1999 and December 2001. Laboratories were assessed by SANAS, which is the single accreditation body in the Republic of South Africa. All documentation relating to the assessment of each laboratory was reviewed in detail by the authors to identify the numbers and classification of non-conformances under each of the 25 points of the check list. A total of 862 non-conformances were raised. The top five non-conformances identified were (1) quality management system, (2) test methods, (3) records and (4) quality control and laboratory safety. The deficiencies identified in South African medical laboratories should be viewed in a positive light and promote a culture of continuous quality improvement with appropriate allocation of resources. SANAS should continue to align its requirements and procedures relating to accreditation of medical laboratories with those of their international counterparts with whom mutual recognition agreements/arrangements exist. 相似文献
9.
Petronella Mathilda van Berkel 《Accreditation and quality assurance》2001,6(4-5):210-213
Proficiency testing by laboratories, national accreditation bodies, and other third parties is becoming more and more considered
as a standard and integral part of the quality control system. Therefore, it is of utmost importance that the quality of the
provided proficiency-testing (PT) service is outstanding. If PT-schemes are set up in order to help laboratories monitor and
improve their quality, PT-schemes need not only be of high quality themselves, but the organizer also needs to be able to
demonstrate this. In The Netherlands formal accreditation of the organization of proficiency testing schemes is used as a
tool to guarantee high quality schemes and also to enable organizers to demonstrate their competence. Since 1996, the Dutch
Council for Accreditation (RvA) has used the ISO-Guide 43–1 to assess PT-organizers in The Netherlands. From January 2000,
the ISO-guide 43–1 was replaced by the ILAC G13 document for assessing organizers. Up till now, four institutes have been
accredited by the RvA for the organization of PT-schemes. 相似文献
10.
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
11.
实验室认可基础、评审方法与发展趋势 总被引:1,自引:0,他引:1
从什么是实验室认可和中国实验室国家认可委员会、实验室评审认可依据和基本要求、实验室认可过程、现场评审技巧和国内外发展趋势五个方面对实验室认可作了介绍,可为我国实验室逐步实现与国际接轨的规范化管理提供借鉴。 相似文献
12.
The history since 1992 and the current state of affairs of the Russian Accreditation system for analytical laboratories are described. Some national characteristics of the implementation of the ISO/IEC 17025 Standard in Russia are considered. The elucidation of some ISO/IEC 17025 Standard prepositions is presented to facilitate implementation of the Standard by accreditation bodies and analytical laboratories claiming accreditation. 相似文献
13.
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
14.
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
15.
The accreditation of laboratories has emphasized the use of interlaboratory comparisons as a tool to monitor the comparability
and accuracy of results laboratories produce. An interlaboratory comparison for water laboratories was organized among European
Cooperation for Accreditation (EA) member countries; 30 laboratories, 7 of which were not accredited, from 14 European countries
participated in this intercomparison. All the laboratories were chosen by the appropriate national accreditation bodies, with
the instruction to select as participants those laboratories which act as national reference laboratories in this field. About
90% of the data collected was considered satisfactory after statistical treatment. Non-accredited laboratories performed as
well as accredited laboratories. The laboratories were asked to take corrective action and report the corrections to the accreditation
bodies. A great variation in the reported uncertainties of the results was observed. There seems to be a need to organize
EA interlaboratory comparisons for national reference laboratories analysing water. It is obvious that even reference laboratories need training in how to estimate the uncertainty of results.
Received: 22 July 1998 · Accepted: 21 September 1998 相似文献
16.
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
17.
Brian E. Broderick 《Mikrochimica acta》1991,105(1-3):17-21
NAMAS, the National Measurement Accreditation Service, was formed in 1985 and has currently accredited some 1050 testing and calibration laboratories in the United Kingdom. NAMAS is managed by an Executive of 60 staff which is based at the National Physical Laboratory, one the UK's largest Government Research Establishments. Laboratories seeking accreditation are assessed by fully trained technical experts contracted by NAMAS, against the criteria set out in the NAMAS Accreditation Standard M10; the criteria contained in this document are fully consistent with the international standards for laboratory accreditation EN 45001 and ISO Guide 25. NAMAS has recently published a document which provides guidance on the interpretation of the NAMAS Accreditation Standard for analytical laboratories. Assessment involves a consultative preassessment visit which is followed by a thorough on-site assessment of a laboratory's quality system and testing activities by a team of expert assessors. Following the correction of any noncompliances found at the assessment, the laboratory receives a certificate of accreditation and a schedule which defines those tests and analyses for which the laboratory is accredited. NAMAS has negotiated a number of mutual recognition agreements with similar accreditation bodies in other countries and negotiations with other schemes are underway. The imminent approach of the European Single Market has highlighted the need for independent third party assurance of testing and calibration and this should ensure the continued growth of NAMAS and similar schemes elsewhere in Europe. 相似文献
18.
Ian Robert Juniper 《Accreditation and quality assurance》1998,3(2):79-82
Certified reference materials are widely used for the calibration of measuring equipment and for the evaluation or validation
of measurement procedures. The use of reference materials makes possible the transfer of the values of measured or assigned
quantities between testing, analytical and measurement laboratories, both nationally and internationally. There is an increasing
number of reference materials producers in other countries, and a demonstration of their scientific and technical competence
is now more widely considered to be a basic requirement for ensuring the quality of reference materials. This article outlines
recent activities by international bodies and their culmination in a scheme of accreditation of certifiers of reference materials
which has been developed by the National Association of Testing Authorities, Australia (NATA). 相似文献
19.
W. van Deijck 《Accreditation and quality assurance》1996,1(5):197-200
Since the late 1980s, much attention has been paid to the usefulness of ISO-9000 certification. At present more than 45000
companies and institutions worldwide have been granted an ISO-9000 certificate. In the field of quality assurance, however,
the ISO-9000 series does not completely cover the aspect of traceability. Demonstrable traceability is a particular problem
in quality assurance of products by chemical analysis. In this paper realisation of demonstrable traceability is discussed,
using the field of gas analysis as an example. Attention is focused on the usefulness of accreditation for laboratories performing
quality assurance analyses. The basic question is asked whether and, if so, when accreditation is worth the trouble in cases
where demonstrable traceability is required.
Received: 15 February 1996 Accepted: 6 March 1996 相似文献
20.
The history, origin, and development of a system for monitoring and assessing water and other environmental laboratories in
the Czech Republic is described. The system started in 1991 and has matured to its present complexity with similarities to
the accreditation systems found in other countries. Differences from internationally recognized procedures are being corrected
step by step. During the first year of its existence ASLAB, as part of its brief, organised proficiency testing (PT) programs
for fifty laboratories. Today the total number of regularly participating laboratories exceeds 700 from the Czech Republic,
the Slovak Republic, and Germany. This paper describes the ASLAB PT system, discusses some experiences with its use, and describes
the use of PT results in assessment of the competence of laboratories.
Received: 12 October 2000 Accepted: 7 January 2001 相似文献