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1.
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
2.
Irina Lutinger 《Accreditation and quality assurance》2002,7(11):494-497
As laboratories continue to downsize, commercialize and become more businesslike in today’s managed care environment, their
present and future success will greatly depend on the efficiency and flexibility of their laboratory information system (LIS).
Today, LIS is a primary tool for managing business and communication. Laboratories that hope to remain competitive in today’s
dynamic health care must continue to implement new and innovative approaches with their LISs.
Received: 26 July 2002 Accepted: 6 August 2002
Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium 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.
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
6.
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
7.
I.-L. Popescu H. Y. Aboul-Enein D. V. Napradean G. L. Radu I. G. Tanase 《Accreditation and quality assurance》2001,6(8):376-378
This paper describes the practical implementation of a quality system in the control laboratory of the National Medicines
Agency, Romania, the main aim being the alignment of the requirements of the control of drugs in Romania with European Union
standards. Activity in this field is relatively new in Romania, however, it is of great importance to Romania’s compliance
with international standards.
Received: 13 September 2000 Accepted: 19 February 2001 相似文献
8.
Herfried Kohl 《Accreditation and quality assurance》1998,3(10):422-425
This paper offers a concise overview of the recent draft of ISO 17025, which is expected to replace EN 45001 in 1999. Reference
is made to the general area of related ISO standards for management systems. The main changes compared with EN 45001 are discussed
for testing laboratories. 相似文献
9.
Hans Olav Folke Andersson 《Accreditation and quality assurance》1998,3(7):281-283
The staff of a laboratory, and its pre-conditions in terms of management principles and work procedures, constitute the basis
for customer satisfaction including the quality of the results. It is argued here that there is a rather limited core of principles
and procedures, the relevant elements of which are essential for "laboratory competence". These elements are treated as part
of the requirements in international quality standards, in particular the draft revision of the ISO/IEC-Guide 25. It is suggested
that it should be possible to structure them in a more flexible way and to integrate the elements into the ordinary management
system of a laboratory. 相似文献
10.
R. Wood 《Accreditation and quality assurance》1996,1(4):140-149
The European Union has prescribed strict quality standards for official food laboratories and the methods of analysis to
be used in laboratories when carrying out official food control work. These requirements, which are based on accreditation,
participation in proficiency testing schemes and using validated methods of analysis, are described in detail. The similar
approach being taken within the Codex Alimentarius Commission is also outlined. The procedures prescribed will ensure that
official food control laboratories have in place the measures to ensure that consistently reliable data can be produced.
Received: 29 November 1995 Accepted: 8 January 1996 相似文献
11.
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
12.
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
13.
Yanhui Zhou Zhubao Zhang Meiyun Zhou Xinyuan Xie Miao Meng Jianxin Meng Dan Li 《大学化学》1986,36(1):2008085-0
Combining the highly internationalized character in Jinan University caring for overseas Chinese, we integrate the technologies and platform of multimedia, QR code and WeChat to build an information education platform including management and safety of laboratories, and experimental courses. The interactive platform provides bilingual contents that meets the requirement of domestic and international students and highly arouse the study interest and stimulate the initiative of students, as a result to improve their comprehensive quality and innovative ability. 相似文献
14.
R. Dybkaer 《Accreditation and quality assurance》2003,8(2):46-52
The establishment of a reference examination system necessary for metrological traceability of the many types of sophisticated
examination result in laboratory medicine is a daunting task, which has been made mandatory by the EU Directive on in vitro
diagnostic medical devices and the requirements for accreditation. Following a definition of examinand and allowed examination
uncertainty, a dedicated calibration hierarchy is established from stated reference through alternating reference examination
procedures and calibrators providing a traceability chain from examination result to the reference, often a definition of
a measurement unit. The various types of possible calibration hierarchy are outlined in EN ISO Standards. Recent efforts by
national and international stakeholders to establish a global reference examination system have led to the creation of a Joint
Committee on Traceability in Laboratory Medicine with the International Committee for Weights and Measures, International
Bureau of Weights and Measures, International Federation of Clinical Chemistry and Laboratory Medicine, International Laboratory
Accreditation Cooperation, and World Health Organization as the principal promoters. This structure will identify reference
procedures, reference materials, and reference laboratories, and seek support for further prioritised and coordinated development
of the system.
Received: 1 August 2002 Accepted: 22 November 2002
Based on a lecture at an IUPAC Seminar, EC JRC Institute for Reference Materials and Measurements, Geel, BE, 2001–12–18
Correspondence to R. Dybkaer 相似文献
15.
16.
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
17.
H. M. Ortner 《Accreditation and quality assurance》2000,5(4):130-141
"Quality management is not just a strategy. It must be a new style of working, even a new style of thinking. A dedication
to quality and excellence is more than good business. It is a way of life, giving something back to society, offering your
best to others" (George Bush 1991).
From this statement it becomes immediately clear that the human factor plays an eminent role in quality management. Therefore,
some important relevant aspects of quality management are highlighted which are not so frequently discussed elsewhere. Various
definitions and statements on quality lead to the fact that quality depends essentially on people. Some thoughts are developed
on the Japanese quality culture which contributed essential impulses to the evolution of certain quality installations such
as quality circles. The Japanese also developed a philosophy of quality, Kaizen, which is significantly different from Western industrial quality concepts. Kaizen works well in a slow growth economy, contrary to Western innovation which is more suited to the fast growth economy of the
past.
Some ideas on the quality control of top management as well as on the quality control of ourselves are expressed and it is
shown how this is related to ethical principles. Every human society is as successful as: its intrinsic degree of honesty
and righteousness, its degree of prevention of corruption and nepotism, and its readiness to work hard for personal advancement
and for the sake of the community. Leadership, political or economic, is a special cultural effort – or at least it should
be. But the striving for quality must be everybody's business in a company. It is the old 'pride of workmanship' which is
greatly lost in today's industrial structures, and which is so absolutely important to again find satisfaction and contentment
in our work. It is shown that the human factor in quality management, apart from all the necessary formal and institutional
regulations, is of major importance, but very often neglected, especially in the present situation of over-rationalization.
It is shown that dynamic equilibria do not only regulate chemical and biological systems but also operate in our psychic world.
Unfortunately, there is a tendency to unhealthy extremes in the latter, e.g. to workaholics or neo-capitalism. Installations
of total quality management such as systems, procedural and product audits are important facets of modern quality assurance.
They are again closely related to human behaviour, as well as the procedure of company and laboratory accreditation. Finally
the "Codex Hammurabi" shows that product liability was a clearly regulated issue in ancient Babylon, 2200 BC. This may be
indicative of the fact that many new trends propagated by management gurus usually stem from a very old part of the wisdom
of mankind but they are newly decorated and formed to modern slogans.
Received: 11 May 1999 / Accepted: 24 September 1999 相似文献
18.
Christian Bonk-Kassner J. Ehmann Gudrun Gallhoff David S. Moore Barbara Moos Bernd Siegemund 《Accreditation and quality assurance》1997,2(6):285-293
Since the 1980s, quality systems have become an essential element in successful companies and institutions. Today those systems are indispensable to fulfill the needs of the customers and last but not least the requirements of the society. Depending on the company's activities and fields of services, it is necessary to establish various quality systems. The Institut Fresenius (IF) Group runs a number of analytical laboratories and sampling groups. The whole group was accredited according to DIN EN 45001 in 1994. Good Laboratory Practice (GLP) was introduced in 1992 and was certified by the national authority. For certain customers, IF Group is also obliged to work according DIN EN ISO 9001 or GMP. A comparison of these systems with respect to their different priorities shows the possibility of integrating their rules into one comprehensive quality system. The IF Group has therefore installed a quality system operating in parallel. Multilocation accreditations and/or certifications are taking these efforts into account. The benefits are: high transparency of the system for the customers, auditors and personnel, a reduction of maintenance costs, and great flexibility to react to new standards. Could these activities lead to a new Integrated Management System? 相似文献
19.
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
20.
There is growing interest in setting up a general concept for quality management and quality control in research and development,
which in this case means, for example, research in the fields of medicine and social sciences. This article is a strong plea
for a quality management system in all fields of research and development and will probably initiate broad discussion on this
delicate topic.
Received: 28 June 1998 · Accepted: 13 July 1998 相似文献