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1.
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
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.
Medical laboratories of the public sector as well as of the private sector on the island of Mauritius are preparing for accreditation. The clinical laboratory of the Central Health laboratory of the Ministry of Health and Quality of Life has undergone a pre-assessment by experts of the International Atomic Energy Agency (IAEA) through the aegis of a project targeted to members of the Africa Region. Several shortcomings were identified and respective corrective actions were recommended for implementation within a given time frame. In addition to ensuring the competence of the laboratory, accreditation has various positive aspects such as an increased awareness of the staff to quality and better training opportunities. The pre-assessment exercise has provided a gap analysis, which is an important aspect in the preparation towards accreditation. 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.
Alain G. Verstraete 《Accreditation and quality assurance》1999,4(3):82-83
A multiple-choice questionnaire was submitted to medical technologists in two medical laboratories, 10 months after the laboratories
had obtained an EN 45001 (Beltest) accreditation. The majority of the technologists (85–90%) considered that their workload
had been increased by the accreditation process but they did not think that the process had improved the quality of their
results. The major advantages were: traceability, the fact that the technologists felt more confident about the procedures
followed, they also received more responsibility and had a better knowledge of the tests performed. The major disadvantages
were the increased paperwork, discrepancies between written procedures and the same procedures in practice, the fact that
more attention was paid to the formalities rather than to the quality of the results and that the accreditation process decreased
the technologists' adaptability. A small majority of the technologists prefered working in an accredited laboratory rather
than in a non-accredited one.
Received: 5 October 1998 · Accepted: 20 October 1998 相似文献
7.
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
8.
9.
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
10.
Hamid Ravaghi Nazanin Abolhassani Parisa Dahim Nasrin Shaarbafchizadeh Soghra Anjarani Nooshafarin Safadel 《Accreditation and quality assurance》2014,19(4):301-305
To establish a national accreditation system for medical laboratories, Iran has set national standards based on the international standard ISO 15189. Central to the accreditation process are the technical assessors. Their attitude in this regard and their experiences should be identified. This study aims to explore assessors’ attitudes toward national laboratory accreditation and their experiences of assessment process in order to identify current gaps and suggest required interventions to solve them. A qualitative study using an open-ended questionnaire was employed. A total of 150 assessors working in the General Directorate of Laboratory Affairs participated in the study. While almost all Iranian laboratory accreditation assessors were generally supportive about the necessity of laboratory accreditation and cited benefits of this process, they pointed to improvement areas including developing assessor selection and appraisal criteria, continuous training, taking into consideration the heterogeneity of laboratories throughout the country, participation of professional associations and adopting measures to increase laboratories’ involvement. 相似文献
11.
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
12.
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
13.
Accreditation of GMO detection laboratories: Improving the reliability of GMO detection 总被引:4,自引:0,他引:4
Jana Žel Katarina Cankar Maja Ravnikar Marjana Camloh Kristina Gruden 《Accreditation and quality assurance》2006,10(10):531-536
Reliable and efficient methods for detecting genetically modified organisms (GMOs) are essential for establishing an effective system for traceability all along the supply chain from seed producers to final consumers. The latter is especially meaningful in European Union and other countries where strict legislations on GMOs were set up. Performance of the methods used in laboratories around the world should be uniform, in order to obtain reliable and comparable results. Accreditation is a suitable system for harmonising procedures in each testing laboratory. In this paper, key elements for the accreditation of molecular biology methods for GMO detection according to ISO/IEC 17025 are described. The procedures described are also valuable for the accreditation of molecular methods for all laboratory diagnostics where qualitative and quantitative characterisation of nucleic acids is needed. 相似文献
14.
Joint Commission International accreditation (JCIA) offers the international community a standards-based, objective process
for evaluating healthcare organizations. The eleven JCIA standards are functionally organized. The standards are grouped by
functions related to the provision of patient care and functions covering the provision of a safe, effective, and well-managed
organization. The focus of the JCIA survey process is on the whole organization rather than on individual departments/services.
The survey is carried out by trained and experienced healthcare peers. Healthcare organizations worldwide should be encouraged
to seek accreditation such as that offered by JCIA. Where affordable, laboratories that are part of larger healthcare organizations
should strive to achieve independent laboratory accreditation. The perspective of a laboratory undergoing a JCIA survey is
briefly presented.
Presented at the conference Quality in the Spotlight, March 2007, Antwerp, Belgium. 相似文献
15.
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
16.
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
17.
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
18.
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
19.
A. Leclercq 《Accreditation and quality assurance》2002,7(7):299-304
Beltest, the Belgian accreditation body, has investigated flexibilization of the scope of accreditation for chemistry laboratories
and food and water microbiology laboratories. This flexibilization, synonymous with test-type accreditation, allows a laboratory
to add new test methods or retry previous test methods without having to undergo a new audit by Beltest. It has been used
for nearly ten years by German and Swiss accreditation bodies. Flexibilization permits the validation of methods and results,
given that the competence of the particular laboratory is already well established. This new concept in microbiology allows
client’s needs to be adequately met, and facilitates the quick establishment of a method in several laboratories at once in
case of a public health crisis. The first laboratory to participate at this investigation on the flexibilization concept,
as a test of the concept, was the Belgian reference laboratory for food microbiology. 相似文献
20.
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