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1.
Peter S. Unger 《Accreditation and quality assurance》1998,3(9):373-376
The American Association for Laboratory Accreditation (A2LA) marks its 20th year of existence. Its major aim as a non-profit,
public service organization is to promote laboratory quality and competence. In terms of the number of current accreditations,
A2LA is the largest multidiscipline laboratory accreditation body in the United States and the fourth largest in the world.
An overview of current activities and status is provided. 相似文献
2.
After the split of the Czechoslovak Federation, the Slovak National Accreditation System was established in November 1993,
being the only system in this country executing accreditation and certification. This system is strictly based on EN 45 000
and covers testing laboratories from both the mandatory and voluntary areas of metrological laboratories, products testing
and certification, quality systems, and good laboratory practice. It seeks to reach the level of compatibility accepted and
recognized by EU member countries. The development and basic features of the Slovak National Accreditation System, its basic
principles, and the structure and competence of accreditation bodies are described in this article. 相似文献
3.
B. L. Collins 《Accreditation and quality assurance》1998,3(9):351-355
The efforts to form a laboratory accreditation cooperation in the United States and North America are described, including
activities of the Laboratory Accreditation Working Group and the interim board of the National Cooperation for Laboratory
Accreditation. The vision, mission, and guiding principles developed by the two groups are presented, along with the operational
documents, such as bylaws, the recognition document, guidance documents and the quality manual drafted by the interim board.
Received: 8 June 1998 · Accepted: 16 June 1998 相似文献
4.
P. Davies 《Accreditation and quality assurance》1996,1(6):240-246
Laboratory accreditation is becoming increasingly accepted around the world as a means of identifying technically competent
laboratories. It is also being used as a mechanism for the acceptance of test data both nationally and internationally. The
concept and mechanisms of accreditation have been developed over the past 50 years. The first national laboratory accreditation
system appeared in Australia in 1947. This organisation, known as the National Association of Testing Authorities (NATA),
has since taken a leading role in developing accreditation practices that are now used world-wide in evaluating testing, measurement
and calibration laboratories. This paper examines the development of the world's first and largest laboratory accreditation
system, and looks at the difficulties and triumphs in gaining acceptance and recognition by government and industry of the
benefits of laboratory accreditation.
Received: 24 June 1996 Accepted: 25 June 1996 相似文献
5.
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
6.
Yoichi Hiraga 《Accreditation and quality assurance》1999,4(4):162-162
Japan Chemical Laboratory Accreditation (JCLA), a new accreditation body in chemical fields was established and the activities
and organization of JCLA are outlined. 相似文献
7.
John W. Locke 《Accreditation and quality assurance》1998,3(9):356-361
Laboratory accreditation in the United States is an old profession. Users and regulators have, it seems, been concerned about
the quality of test data they obtain from laboratories for well over half a century. These users have developed many different
systems to meet their needs. As a result, there is much duplication of effort and overlapping in accreditation requirements
and many laboratories have to maintain current accreditation from a number of organizations. A number of attempts have been
made over the years to reduce this duplication, but it still remains. In the meantime, rapid progress has been made internationally
to recognize laboratory accreditation systems in different countries. This paper describes this situation and speculates on
the future, considering the international thrust to simplify and consolidate conformity assessment procedures.
Received: 26 May 1998 · Accepted: 6 June 1998 相似文献
8.
A. Rabinovitch 《Accreditation and quality assurance》2002,7(11):473-476
The College of American Pathologists (CAP) operates voluntary programs in proficiency testing (PT) and quality monitors, which
are briefly described. Additionally, a peer-based laboratory accreditation program covers over 6,100 clinical laboratories.
Participation requires successful PT and on-site inspections using a series of 18 checklists structured along traditional
subdisciplines of laboratory medicine and anatomic pathology. The laboratory general checklist contains over 250 questions
covering broad issues affecting all disciplines. Among these are three items within the computer services section that specifically
probe the laboratory’s use of autoverification. Data autoverification is defined as the process by which the computer performs
the initial verification of test results; any data that fall outside of set parameters should be reviewed by the human operator.
Central to these questions is the role of the laboratory director in approving the rules and validation. CAP does not define
the specific technical details, recognizing the uniqueness of each laboratory setting and the patients it serves.
Received: 8 August 2002 Accepted: 10 August 2002
Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium
Correspondence to A. Rabinovitch 相似文献
9.
Rob T. P. Jansen 《Accreditation and quality assurance》2000,5(9):363-366
Most efforts in quality control have been focussed on the reduction of intralaboratory variation and the assessment of interlaboratory
variation. Over the last few years, the importance of bias in interlaboratory variation and intralaboratory shifts has become
clear. Small shifts can sometimes have a large impact on the number of treated patients, particularly in assays where cut
off values are used. For example in cholesterol, HDL-cholesterol, HbA1c and TSH assays. There is an obvious need for adequate
calibration material. However, the process of development of international primary reference materials and reference methods
takes time, and even if reference materials exist and are used by in vitro diagnostics manufacturers, there still remains
significant and clinically relevant interlaboratory variance and intralaboratory shifts, as is seen, e.g. in protein chemistry.
The harmonization of inter laboratory and intralaboratory results needs an impulse from professional organizations to convince
individual laboratories of the importance and significance of bias. This applies to all subdisciplines of laboratory medicine.
On the occasion of the 25th anniversary of the Foundation for External Quality Assessment (SKZL), a large interdisciplinary
harmonization project called Calibration 2000 was launched in The Netherlands The strategy and first results are reported
in this paper. The project aims at harmonization of laboratory data of several disciplines, using secondary calibration materials,
leading to common reference ranges throughout The Netherlands.
Received: 15 April 2000 · Accepted: 15 April 2000 相似文献
10.
Henry Travers 《Accreditation and quality assurance》2002,7(8-9):364-366
Providing laboratory external quality assessment (EQA) programs for countries in need requires special considerations not
ordinarily part of EQA for laboratories in industrialized countries. Cultural, professional, service and economic factors
must be understood and accommodated in order to carry out successful programs. Coordination of worldwide efforts for countries
in need requires more resources and planning than have thus far been devoted to the enterprise. 相似文献
11.
A. Steinhorst 《Accreditation and quality assurance》1998,3(7):294-295
DACH, the German accreditation body of chemistry, which was founded in 1992, has introduced a new model for the flexibilization
of the scope of accreditation. This ensures that the accreditation of a laboratory also guarantees flexibility. Flexibilization
of the scope of accreditation is of great importance, in particular if a great number of similar routine tests (standard methods)
or non-routine tests are to be accredited. The main tool of flexibilization is the accreditation of types of tests. The accreditation
of types of tests entitles laboratories to include additional test methods within the type of test accredited without informing
the accreditation body immediately. Such information is provided at fixed surveillance intervals. The conditions for the accreditation
of types of tests are described below. 相似文献
12.
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
13.
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
14.
F. Linnebank 《Accreditation and quality assurance》2000,5(9):377-380
The Netherlands Institute for Accreditation of Hospitals (NIAZ) was established at the end of 1998. It was founded by the
PACE foundation, the Society of University Hospitals, the Netherlands Association of General Hospitals and the Society of
Medical Specialists in the Netherlands. Since then in the Netherlands 19 pilot accreditations have been performed based upon
35 NIAZ-PACE standards for hospital departments and functions, and the overall standard 'quality system'. The aims and methods
of the accreditation system were inspired by examples from the other side of the Atlantic, especially from Canada. The characteristics
are: voluntary-based, self-evaluation, peer-review and aiming at continuous improvement of quality of care.
Received: 15 April 2000 · Accepted: 15 April 2000 相似文献
15.
Environmental quality is still deteriorating in the EU and worldwide despite all the Directives and Regulations in this field
over the past 20 years. The European Community has devised a new approach to this problem with the introduction of the Eco-Management
and Audit Scheme Regulation. This Regulation provides industry with an opportunity to demonstrate that it can achieve continuous
improvement in its environmental performance through a voluntary scheme which is not based on the traditional command and
control mechanisms of Directives. This paper gives an overview of the steps involved in implementing the European Eco-Management
and Audit Scheme and the role of accreditation in supporting the scheme. 相似文献
16.
R. L. Robertson 《Accreditation and quality assurance》1996,1(5):213-217
The National Associating of Testing Authorities, Australia (NATA) is a laboratory accreditation company that has been involved
in the accreditation of pathology laboratories since 1982. This role is carried out in conjunction with the Royal College
of Pathologists of Australasia (RCPA). The accreditation process is known as the NATA/RCPA scheme. The NATA/RCPA accreditation
scheme originated from the desire to raise professionalstandards in pathology. The scheme aimed to achieve this through a
peer review process in which education and voluntary participation were stressed. In 1986, the Australian Federal Government
adopted the scheme as its measure of the competence of testing by pathology laboratories seeking payment from the Commonwealth
Department of Human Services and Health reimbursement scheme, Medicare. This meant that NATA/RCPA accreditation became mandatory
for such laboratories. The benefits of peer review as a means for establishing professional competence and the challenges
a mandatory accreditation program poses to such a scheme will be discussed.
Received: 6 May 1996 Accepted: 29 May 1996 相似文献
17.
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
18.
Calibration of measuring equipment is conducted by following some normative or applicable documents such as standards, manufacturer manuals and instructions, technical orders issued by defense organizations, or scientific papers. An accreditation body provides its recognition to the calibration laboratories by evaluating their technical competence and their compliance with the quality requirements of ISO/IEC 17025. The accreditation body must have defined criteria in order to evaluate different calibration methods which should ensure that the laboratories are performing the calibration in a technically competent manner when they are fully or even only partially based on the relevant reference documents. A discussion with different points of view about choosing the criteria, as well as the Israel Laboratory Accreditation Authority (ISRAC) policy on this issue, are presented.Presented at the 2nd International Conference on Metrology – Trends and Applications in Calibration and Testing Laboratories, November 4–6, 2003, Eilat, Israel. 相似文献
19.
Brian Belanger 《Accreditation and quality assurance》2001,6(3):100-102
During the last quarter of the twentieth century, The United States National Bureau of Standards (NBS), later the National
Institute of Standards and Technology (NIST), introduced a measurement quality control concept called ”measurement assurance,”
and developed measurement assurance programs, or MAPs, for high-level calibration processes. The measurement assurance approach
has, over time, become increasingly popular in the metrology community, and in recent years has become well accepted both
inside and, to some extent, outside the United States as a rigorous way to ensure the quality of calibrations. The concept
has also found application in defining traceability to national standards. This paper traces the history of the measurement
assurance concept.
Received: 23 October 2000 Accepted: 2 November 2000 相似文献
20.
A. M. H. van der Veen A. Alink D. Verkuil B. van der Lecq 《Accreditation and quality assurance》1996,1(5):207-212
Working group 5 of EuraChem Nederland has developed a framework for the implementation of reference materials in analytical
chemistry. In this discussed paper, the framework is proposed as a tool for the development of standard operation procedures
(SOPs) in laboratories. The implementation of (certified) reference materials in these SOPs is of major importance in establishing
comparability and traceability in measurement results, which in turn play a crucial role in measurement in support of trade,
environmental issues, and characterisation of materials. Recent developments in the field of uncertainty analysis require
the application of reference materials. It is recognised that the calculation of the combined measurement uncertainty becomes
almost impossible without the use of certified reference materials with a stated uncertainty.
Received: 1 December 1995 Accepted: 20 December 1995 相似文献