共查询到20条相似文献,搜索用时 654 毫秒
1.
Qiao Dong 《Accreditation and quality assurance》2002,7(4):171-172
This document gives a brief introduction to CNACL (China National Accreditation Committee for Laboratories). Laboratory accreditation
in China is integrally administrated by the China State Bureau of Quality and Technical Supervision, a government administrative
department of China State Council, which authorizes CNACL to implement Chinese laboratory accreditation activities. CNACL
was established on September 20, 1994. It is a full member of both ILAC (International Laboratory Accreditation Cooperation),
and APLAC (Asia Pacific laboratory Accreditation Cooperation), and signed the APLAC MRA (Mutual Recognition Arrangement) in
New Delhi, India on December 3, 1999. CNACL carries out laboratory accreditation activities in full compliance with international
general criteria. Its operation complies with ISO/IEC Guide 58 (1993), ISO/IEC 17025 (1999), ISO/IEC Guide 43 (1997) and other
international standards. 相似文献
2.
An interlaboratory comparison study for the determination of 5 residual organochlorine pesticides (hexachlorobenzene and 4 hexachlorocyclohexane isomers) in ginseng root was performed. This program [Asia Pacific Laboratory Accreditation Cooperation (APLAC) T049] was the first of its kind for an herbal matrix and involved the participation of 70 laboratories from 26 countries worldwide. Consensus mean values were computed statistically from the reported results, which were eventually used to assess the performance of individual laboratories in terms of the z-scores. The distribution of analytical data was found to be widespread, with standard deviation ranging from 43.9 to 55.9%, and the result patterns obtained were similar to those residue pesticide programs using other matrixes. Although the estimation of measurement uncertainty is a crucial requirement for all quantitative tests for laboratories that meet the requirements of International Organization for Standardization/International Electrotechnical Commisssion (ISO/IEC) 17025, some laboratories in this program had difficulties and showed unfamiliarity with respect to that quality criterion. It was recommended that laboratories review and rectify the situation promptly so that they would have a better understanding of measurement uncertainty or the test service provided. 相似文献
3.
Accreditation of testing and calibration laboratories is the most frequently used type of accreditation. European Co-operation
for Accreditation (EA) as the European network of recognised national accreditation bodies covers accreditation of all types
of conformity assessment bodies. In Europe, the number of accredited testing and calibration laboratories covered under the
EA Multilateral Agreement is about 15,000 nowadays. 相似文献
4.
Khalid Saeed 《Accreditation and quality assurance》2016,21(4):305-308
ISO/IEC 17025:2005 states that its requirements are “applicable to all laboratories regardless of the number of personnel” and would therefore include single-operator laboratories. However, there are reservations as to whether these laboratories can comply with all of the requirements without jeopardizing independence of judgement and impartiality. Similarly, there are some requirements of ISO/IEC 17025:2005 including staff supervision, internal communication processes and appointment of deputies that are considered unlikely to apply to a single-operator laboratory. The ISO/IEC 17025:2005 is widely used as the international standard of quality assurance by which accreditation bodies assess the competency of testing and calibration laboratories. There does, however, appear to exist, disagreement amongst accreditation experts when considering single-operator laboratories. Some accreditation bodies accredit single-operator laboratories, whilst others require additional human resources prior to granting accreditation. This discrepancy leads to unfair competition amongst laboratories as a single-operator laboratory by definition needs less resources (both human and financial) to achieve and maintain accreditation, compared with a laboratory where additional human resources need to be sought prior to and in order to maintain accreditation. The ISO/IEC 17025:2005 is in the process of being revised, and this is an opportune moment to address the issues aforementioned with the aim of removing ambiguity and enhancing clarity. In addition, the hope is to assist the accreditation bodies themselves to adopt a consensus approach when granting accreditation towards single-operator laboratories. 相似文献
5.
Gotthard Staats 《Fresenius' Journal of Analytical Chemistry》1993,345(12):739-743
Summary The relationships between Quality, Quality Assurance and Third Party Approval by accreditation based on formal application of EN 29002, EN 45001 and ISO Guide 25 are briefly outlined for analytical chemical laboratories working in the non-regulated area. The roles of human beings in laboratories and accreditation bodies are discussed and recommendations are made on how to minimize friction during accreditation processes. The structures of the European Accreditation Systems are reviewed and the efforts towards mutual recognition of the national accreditation bodies are described and critically assessed. The lack of competition based on free market conditions in the framework of company law is deplored. The assessment of laboratory systems, rather than assessing the activity of laboratories against technical standards, is recommended (unless it is otherwise requested). The beneficial effects of the process of accreditation on competence and quality of the activity of the laboratory are emphasized. 相似文献
6.
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
7.
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
8.
The analytical laboratories accreditation system (SAAL) began its work in 1992. At first, SAAL was created for laboratories
performing quantitative chemical analysis, but its activities have constantly expanded. SAAL presently covers laboratories
determining oil and petroleum properties, properties of construction materials, parameters of dangerous and harmful industrial
goods, precious stones, rubber, plastic, metals etc. Today, SAAL comprises over 3,000 accredited laboratories, 34 accreditation
bodies and over 200 assessors united under the Federal Agency on Technical Regulating and Metrology. Within the Russian Federation,
SAAL is recognized by various bodies and organizations as a reliable tool in the demonstration of technical competence of
laboratories. This report is devoted to the history of SAAL, describing the separate stages of its development, evolution
of its requirements for laboratories and accreditation procedures, the principles on which SAAL was based, and conformity
of these principles to the legal requirements of the Russian Federation.
Presented at the 3rd International Conference on Metrology, November 2006, Tel Aviv, Israel. 相似文献
9.
Stephen W. C. Chung Jeff C. H. Tran W. W. Wong 《Accreditation and quality assurance》2012,17(1):35-44
A proficiency test (PT) to assess the capabilities of laboratories to determine nutrients in a biscuit sample was carried
out in September 2009. The need for such interlaboratory comparison arose from an increasing nutrition labeling requirements
of different countries around the world. Forty-eight laboratories worldwide participated in this PT program for the determination
of total lipids, saturated fat, trans-fat, protein, sugars, total dietary fiber (TDF), ash and sodium in food. This program
was organized under the auspices of the Asia-Pacific Laboratory Accreditation Cooperation (APLAC). APLAC considers PT programs
as one of the objective means of assessing the performance of the accredited laboratories. The program is one of the APLAC
PT series whose primary purposes are to establish mutual agreement on the equivalence of the operation of APLAC member laboratories
and to provide an opportunity to identify testing deficiency so that corrective actions can be taken, if necessary. The results
of this program indicated that the consensus mean values estimated by robust statistics were in good agreement with the corresponding
values obtained in the homogeneity tests except for trans-fat and TDF. The relative standard deviations of participant results
for trans-fat and TDF were also found to be higher (19 and 24%, respectively) than the other test parameters. The relative
standard deviations for other test parameters were less than 10%. One-half of the laboratories obtained satisfactory z-scores
(| z | < 3) (\left| z \right| < 3) for all their reported results. Although participants were instructed to provide the measurement uncertainties of their reported
results, only 27.5% of them had done so. Albeit many of the measurement uncertainties appear to be reasonable, some of them
were found to vary widely, indicating that some laboratories still have difficulties in estimating measurement uncertainties.
Although the overall measurement capability can be considered to be satisfactory, there is still room for improvement of analytical
procedures. 相似文献
10.
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
11.
Valentina Biasini 《Accreditation and quality assurance》2012,17(6):621-626
In recent decades, it has become increasingly important for public research centres to attract external clients, including government, private and public bodies and companies. They do this by demonstrating their research excellence. A research centre??s ability to provide professional research services can be assessed by competent technical bodies which verify that the research centre??s laboratories operate according to certain predetermined criteria or standards. Although there is no set of generally accepted standards, some regional accreditation bodies already offer accreditation assessment for the R&D laboratories which are in their territory. This article analyses the successful application of a quality management system in a public research centre employing 57 people including researchers, technicians and administrative staff. This system is based on the scheme of regional accreditation of industrial research laboratories which was inspired by ISO 9001:2008 and ISO 17025:2005 and set up by the regional authority. The overall aim of the management system is to monitor all of the industrial research and services which the centre offers to external users, such as government, private and public bodies and companies, and to guarantee that final products, usually technical reports and prototypes, respond to their needs. The accreditation applies to all of the activity of the research centre except for basic research. In this article, the critical factors influencing the success of the implementation of the management system are outlined together with benefits and opportunities. Weak points and problems are analysed, and the actions which were undertaken in order to prevent and manage problems are described. 相似文献
12.
P. S. Unger 《Accreditation and quality assurance》2001,6(12):521-522
As of August 2001, 38 laboratory accreditation bodies of the International Laboratory Accreditation Cooperation (ILAC) have
signed the multi-lateral, mutual recognition arrangement (the ”ILAC Arrangement”) to promote the acceptance of accredited
test and calibration data. This Arrangement provides significant technical underpinning to international trade. Until now,
there has been no international mutual recognition agreement in laboratory accreditation, which has been a hindrance for some
types of international trade. The key to the Arrangement is the developing global network of accredited testing and calibration
laboratories that are assessed and recognised as being competent by ILAC Arrangement signatory accreditation bodies. The signatories
have, in turn, been peer-reviewed and shown to meet ILAC’s criteria for competence. Now that the ILAC Arrangement is in place,
governments can take advantage of it to further develop or enhance trade agreements. The ultimate aim is increased use and
acceptance by industry, as well as government, of the results from accredited laboratories, including results from laboratories
in other countries. In this way, the free-trade goal of ”a product tested once and accepted everywhere” can be realised. 相似文献
13.
The proficiency testing (PT) program for 97 worldwide laboratories for determining total arsenic, cadmium, and lead in seawater shrimp under the auspices of the Asia-Pacific Laboratory Accreditation Cooperation (APLAC) is discussed. The program is one of the APLAC PT series whose primary purposes are to establish mutual agreement on the equivalence of the operation of APLAC member laboratories and to take corrective actions if testing deficiencies are identified. Pooled data for Cd and Pb were normally distributed with interlaboratory variations of 21.9 and 34.8%, respectively. The corresponding consensus mean values estimated by robust statistics were in good agreement with those obtained in the homogeneity tests. However, a bimodal distribution was observed from the determination of total As, in which 14 out of 74 participants reported much smaller values (0.482-6.4 mg/kg) as compared with the mean values of 60.9 mg/kg in the homogeneity test. The use of consensus mean is known to have significant deviation from the true value in bi- or multimodal distribution. Therefore, the mode value, a better estimate of central tendency, was chosen to assess participants' performance for total As. Estimates of the overall uncertainty from participants varied in this program, and some were recommended to acquire more comprehensive exposure toward important criteria as stipulated in ISO/IEC 17025. 相似文献
14.
In the view of the Deutscher Kalibrierdienst (DKD) , a certifying body for reference materials can be considered to be a calibration laboratory. Therefore, accreditation of calibration laboratories in accordance with ISO/IEC 17025 is the most appropriate way to establish confidence in certificates for reference materials. If necessary, the criteria of ISO/IEC 17025 can be tailored to specific cases. There is no need to provide any new kind of reference-material specific accreditation. However, in view of the variety of reference materials and the practice existing in other countries, accreditation of testing laboratories and product certification bodies may optionally be acceptable as long as the same stringent principles with respect to traceability and measurement uncertainty are applied. Such accreditations but not accreditations of reference material producers (ISO Guide 34) are also covered by existing international mutual recognition arrangements (MRA). 相似文献
15.
Saloua Ghedamsi 《Accreditation and quality assurance》2009,14(11):619-621
The concept of metrology first appeared in Tunisia towards 1909. At the end of the 1990s, bodies for evaluating conformity
of measurement at different levels have been instituted to meet calibration and testing needs of the national industry. These
bodies were divided into three categories: Class A where we find mainly the Central Laboratory for Analysis and Testing LCAE
and the National Defence Laboratory DEFNAT; these two laboratories are in charge of the technological upgrading of the other
bodies of Class B which, in turn, would transfer their knowledge to the industries, the latter constituting Class C. Nowadays,
the accreditation of Tunisian laboratories at the international level by recognized reference foreign bodies and participation
in the European proficiency network enabled the national laboratories of Tunisia to establish the degree of equivalence between
their measurement results and those of other foreign laboratories. 相似文献
16.
Nick Boley Adriaan van der Veen Andreas Müller Angelika Recknagel Bernd Steffen M. Golze 《Accreditation and quality assurance》2001,6(4-5):205-207
Because proficiency testing (PT) is increasingly used for the accreditation of testing laboratories and as a tool for backing
up existing multilateral recognition arrangements between accreditation bodies, the question of performance and comparability
of the proficiency-test providers arises. In this paper different approaches to assess the equivalence of European PT schemes
and the competence of their providers are presented. As a first step a workshop is proposed to agree on a pilot study. The
final aim is to create confidence in the existing PT schemes in Europe and to use them as common European tools. 相似文献
17.
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
18.
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
19.
K. J. Albutt 《Accreditation and quality assurance》1998,3(7):279-280
Accredited laboratories are the accreditation bodies customers – all other interested parties are stakeholders. The ultimate
consumer expects his product to be safe, reliable and good value for money. All other expectations in the supply chain relate
to the consumer's expectations. 相似文献
20.
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