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1.
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
2.
An open mind is essential for the implementation and improvement of total quality management. Leadership, as such, is of
no value without a vision concerning corporate culture and human resources. Therefore, constant communication between partners
within a corporate body is the cornerstone for empowerment. The evaluation of ideas and complaints is considered to be essential
for the identification of strengths and weaknesses of a system, whereas, competition and benchmarking may reveal surprising
opportunities for improvement. We discuss the idea that customer-oriented efficiency in a hospital environment may be classified
as a critical success factor. 相似文献
3.
P. Bode K. Heydorn R. W. Innes R. Wood R. Zeisler 《Accreditation and quality assurance》1998,3(5):197-202
Laboratory managers are facing the task of altering the attitudes of themselves and their employees in order to implement
a quality lifestyle, which is the prerequisite for successful implementation of a quality system complying with appropriate
international standards. The alterations require a painstaking and constructive approach. Not all laboratories have the resources
to secure the assistance of quality consultants. For those laboratory managers who have to find their way towards quality
management on their own, some recommendations are given for a path towards a self-sustaining quality system. Several practical
aspects of the basic steps in this path, which starts with assessing the current status of the laboratory and is followed
by awareness building, are discussed. The recommendations are derived from the experience of the authors in their own laboratories.
Received: 5 June 1997 · Accepted: 7 December 1997 相似文献
4.
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
5.
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
6.
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
7.
G. M. Overvliet 《Accreditation and quality assurance》1999,4(4):139-142
This article presents an overview of the practical experience acquired in two governmental medicines control laboratories
in the Netherlands which combine the application of EN 45001 and ISO 9002 standards in the regulatory field of quality and
risk assessment, and quality control of medicines and medical devices. This practical experience also includes simultaneous
accreditation and certification. The EN 45001 standard was applied to laboratory testing activities and the ISO 9002 standard
to non-laboratory file assessment activities as these activities are not covered by the scope of EN 45001. It appears that
a combined application of these standards is practicable because they complement each other well. EN 45001 strongly emphasises
technical competence. ISO 9002, on the contrary, emphasises more strongly the efficiency of the management processes and customer
requirements.
Received: 1 October 1998 · Accepted: 21 December 1998 相似文献
8.
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
9.
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
10.
Sara M. Resnizky Rita R. Plá Raquel C. Jasan Sonia E. Hevia Mónica A. Moreno Rodrigo Invenizzi 《Accreditation and quality assurance》2006,10(11):590-593
The implementation of a quality system based on the ISO/IEC 17025:1999 standard is a growing necessity for analytical laboratories to demonstrate their technical competence. In 2001, the Nuclear Analytical Techniques Group of the Argentine Atomic Energy Commission obtained the recognition of the International Atomic Energy Agency in the application of neutron activation analysis and the accreditation by the national accreditation body. The importance of the participation of the group in the Agency's Regional Programme for Latin America, ARCAL XXVI on Quality Assurance in Analytical laboratories is discussed, as well as the activities performed to attain these objectives. Some improvements worth mentioning resulted from the implementation of the quality system and, following the premise of continuous improvement, changes were introduced aiming at the laboratory re-accreditation. 相似文献
11.
L. Burnett D. Chesher D. Groot-Obbink G. Hegedus M. Mackay A. Proos C. Rochester W. Shaw A. Webber 《Accreditation and quality assurance》2002,7(6):237-241
Quality systems can provide a means of measuring the rate of occurrence of defined incidents and non-conformities. We have
studied the application of laboratory quality systems to monitoring the implementation of laboratory information systems (LIS)
in two similar size tertiary hospital pathology laboratories in Australia. At one site, one department implemented a quality
system accredited to ISO 9001–1987 and ISO 9001–1994 while the rest of the organisation did not have a formal quality system;
this site implemented the Cerner PathNet LIS. At the other site, the organisation was in the process of implementing ISO/IEC
Guide 25–1990 and ISO/IEC 17025–1999; this site implemented the PJACC AUSLAB LIS. The rate of quality system incidents and
non-conformities was used to track the progress of implementation of the LIS. We found that different quality systems appeared
equally useful in monitoring the rate of occurrence of incidents. However, the presence of a formal quality system greatly
improved the proportion of incidents that could be investigated and resolved at root cause level. Incident monitoring, as
part of a formal quality system, proved to be a useful tool in monitoring and managing the implementation of these LIS.
Received: 4 August 2001 Accepted: 21 March 2002 相似文献
12.
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
13.
P. Schmidt 《Accreditation and quality assurance》1999,4(4):129-132
The Analytical Laboratory of BASF is a central service unit for chemical analysis which can be used by all departments within
the company. It carries out routine as well as non-routine work and has a high amount of R&D orders. A quality system conforming
with GMP rules was installed in the 1970s, followed by a GLP system about 6 years later. In 1995 an EN 45001 certificate was
granted, which also stated the conformity with ISO 9002. A "types of test" orientated system was chosen for accreditation.
This was better suited to the needs of a testing laboratory with a high amount of non-routine work than a purely test-procedure
orientated accreditation. An integrated quality system has now been developed from these activities. It has partly common
elements and partly differing elements taking into account specific regulations. For example, instrument calibration, staff
training, validation of test procedures and the use of computerized systems are covered by uniform rules. Other elements such
as handling of samples and report generation are arranged according to the individual requirements of the various standards.
Rules and regulations are laid down in a system of documents which comprise the quality manual, general standard operating
procedures (SOPs), laboratory-specific SOPs and test procedures. The quality system has been accepted by other accreditiation
bodies on application of special accreditations (workplace safety, biodegradable polymers). But it has had no advantageous
influence on getting GLP certification. An integrated system is very complex and requires appreciable resources. Management
of processes and documentation can only be handled by extensive use of computers. Frequent training of staff and internal
audits are necessary to keep the system at an acceptable level. In order to reduce the complexity of quality management regulations
a harmonization of the different quality systems would be desirable.
Received: 1 October 1998 · Accepted: 10 January 1999 相似文献
14.
This article is devoted to the role of reference materials (RMs) in chemical analysis and their main applications in analytical
laboratories. The principal requirements of the RMs used in accredited laboratories in the Russian Analytical Laboratories
Accreditation System (SAAL) are presented. These include the basic regulatory and metrological requirements of RMs. Finally,
a review of the provision of RMs used for the analytical control of various test objects is presented.
Received: 9 August 1998 / Accepted: 9 November 1998 相似文献
15.
L. Burnett Colin Rochester Mark Mackay Anné Proos Warwick Shaw Gabe Hegedus 《Accreditation and quality assurance》1997,2(2):76-81
The Department of Clinical Chemistry and Molecular Genetics, within the Institute of Clinical Pathology and Medical Research
at Westmead Hospital, is a medical testing laboratory operating within the public sector health system of New South Wales,
Australia. It provides acute-care pathology services to Westmead Hospital (a 900-bed tertiary referral university teaching
hospital) as well as to three district hospitals and three rural hospitals. In addition to these core clinical chemistry services,
it offers approximately 150 specialised biochemistry, pharmacology, toxicology, trace metal and molecular genetics assays
as a reference laboratory service. In 1993, the Department became Australia's first medical testing laboratory to be registered
to ISO 9001-1987/AS3901-1987. In 1995, this certification was extended to AS/NZS ISO 9001-1994. We are currently preparing
for further accreditation to ISO/IEC Guide 25-1990, with additional supplementary requirements for medical testing. This paper
describes the Quality System that the Department developed and which has been successfully maintained and extended since original
certification. Important features of the Quality System are:
1. Primary design of the Quality System to meet medical and customer needs, with subsequent addition of required ISO elements.
2. Use of national Quality Award criteria to identify key business processes.
3. Development of integrated technical non-conformance, customer complaint, staff suggestion, and quality system corrective
action procedures.
4. Implementation without external resources.
Our conclusions are that ISO 9000 Quality Systems can be applied to medical testing laboratories, and can be implemented with
minimum resource costs. Improvements in technical and service quality and business performance have resulted from this process.
However, implementation of ISO 9000 at the level of individual Departments is not ideal. Greater improvements are possible
when this process is undertaken at the level of the entire organisation.
Received: 9 September 1996 Accepted: 5 October 1996 相似文献
16.
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
17.
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
18.
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
19.
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
20.
C. L. Burns 《Accreditation and quality assurance》1997,2(7):327-331
The accreditation procedure that the Department of Laboratory Sciences, CHPPM-Europe underwent is described. The laboratory
obtained ISO/IEC 25 accreditation through the American Association for Laboratory Accreditation (A2LA) and the Deutsches Akkreditierungssystem
Prüfwesen (DAP) as well as EN 45001 from DAP following the A2LA and DAP joint inspection. The accreditation process and the
importance of obtaining national and international accreditation are discussed.
Received: 30 May 1997 · Accepted: 16 June 1997 相似文献