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1.
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
2.
Solveig Linko 《Accreditation and quality assurance》2002,7(2):55-59
Internal audits inherently effect quality improvement, and concrete results can be expected by careful planning. As audits
should improve the quality system in situ, the development of audits should not be neglected. ISO/IEC 17025 describes the
objectives of internal audits and management reviews in more detail compared to the former standards EN 45001 and ISO/IEC
Guide 25, although the main features are unchanged. This addresses continuous surveillance of the current practice. A brief
questionnaire on vertical audits was distributed to 74 of 120 employees at a Finnish private medical laboratory, Medix Laboratories
Ltd. A positive feed-back was received from the current management of audits. However, the study revealed that continuous
supervision of audits is needed. Many employees were not willing to perform audits if they had no previous experience. Additionally,
audits performed at the workbench were not considered as the best possible for fruitful discussions.
Received: 20 February 2001 Accepted: 30 November 2001 相似文献
3.
J. Forstén 《Accreditation and quality assurance》2002,7(6):234-236
The first experiences of implementing of ISO/IEC 17025 have been obtained by the accreditation bodies and laboratories following
the standard, and a workshop to discuss the experiences was arranged. This presentation gives the conclusions and recommendations
from the workshop based on the lectures and discussions. In general, the adoption of ISO/IEC 17025 has been a smooth process.
Received: 28 February 2002 Accepted: 2 March 2002 相似文献
4.
Anita Schmidt 《Accreditation and quality assurance》2001,6(6):277-278
The 5th Eurolab Symposium on 4th and 5th October in Edinburgh was the highlight event of Eurolab in 2000, Eurolab’s 10th anniversary
year. Under the title: ”Confidence in Testing Services – new expectations, new rules, new challenges” it reflected recent
changes and developments in the laboratory scene and focussed on new tasks and challenges. The most essential changes for
laboratories are connected with the new standard ISO/IEC 17025 ”General requirements for the competence of testing and calibration
laboratories”. Keywords in this respect are uncertainty of measurement and traceability to SI units, requirements on personnel,
proficiency testing, customer orientation, and management systems. 相似文献
5.
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
6.
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
7.
The experience of implementing a quality system on ISO 17025, and the accreditation of some tests for a university laboratory,
is presented in the example of the Environmental Radiology Laboratory. Such implementation in a university institution is
a difficult task, since the setting and environment are both unfavourable. The particularities are the collaboration of many
independent units of the university, and the involvement of teachers and young researchers who have to coordinate all these
different tasks, which makes the number of people working quite variable. Some specific aspects of the system are discussed.
The conclusion is that implementation of a quality system on ISO 17025 and accreditation are completely achievable, and are
helpful activities to put university members in touch with the real world and broaden their minds, which in the end has a
positive impact on research studies and academic content. 相似文献
8.
Public Health Laboratories (PHL) as part of Public Health Services are involved in law enforcement and ensuring food and water
quality. The laboratories had to go through an organizational and monetary change imposed by the growing and changing needs
of the state of Israel. The laboratories had to become more modern and to implement new and more sophisticated testing methods.
Another requirement was to perform a steadily increasing number of tests and to be more flexible towards customers’ demands.
Yet, the budget was not changed accordingly, as the Public Service to which the laboratories belong to do not respond to changing
needs. Management realization was that the accreditation process could be used as a tool to achieve organizational and cultural
change. Understanding and transformation were required throughout the organization, including management. Proficiency testing
is performed for all testing methods in all areas even for non-accredited tests such as clinical tests. Proficiency testing
was used as a tool for organizational culture change. It is a great index with game elements, that gives employees and managers
the possibility for comparison, fixing problems and corrective action. The demands of ISO 17025 made it necessary to change
peoples’ attitudes and views on both professional and communication levels. Laboratory quality consists now on the four main
principles, described in the 5M&E model which is typical to small organizations and which ensures a constantly improving system:
”Policy statement”, ”Machine”, ”Material”, ”Measurement”, ”Method”, ”Manpower”, and ”Environment” targeted to achieve ”Quality
upgrade”. Slowly we succeeded in providing better and more reliable services and have increased our income on what would hopefully
become our way to financial independence. We hope this process would provide the Ministry of Health with a better chance to
public health using the same financial sources.
Received: 25 October 2000 Accepted: 12 December 2000 相似文献
9.
Dimitris G. Theodorou Panagiotis C. Anastasakis 《Accreditation and quality assurance》2009,14(2):107-110
Management reviews are key processes in many quality-management systems, including laboratory-management systems, in accordance
with ISO/IEC 17025 and ISO 15189. These reviews are fine opportunities to understand and manage all the inputs and outputs
of a quality-management system. Laboratories often meet some difficulties fully exploiting the management-review process because
either they do not realize the importance of this process or they do not have the experience to run this process in a way
producing the intended results. This work presents a management review checklist which helps laboratories carry out an effective
management review going through all the important aspects of the quality-management system. 相似文献
10.
11.
The practical experience on the implementation of ISO/IEC 17025 compliant quality system in a nuclear analytical laboratory of the Korea Atomic Energy Research Institute (KAERI) is described. This paper summarizes the need for a quality system and accreditation, the process of a quality system implementation, the quality system structures, and the formal accreditation of our laboratory by the Korean Laboratory Accreditation Scheme (KOLAS). Also, the improvements in the management, technical and service quality which resulted from implementation of this system are briefly reported. 相似文献
12.
The motives for and the implementation of a quality system complying with the requirements of the ISO/IEC 17025 standard in a gamma-ray spectrometry laboratory are briefly described, as well as its influence on the laboratory's work and output. The use of the quality system as a tool for managing and controlling the state of the laboratory is described. Two examples of control and improvement of the laboratory's performance are given. 相似文献
13.
Jarl Forstén 《Accreditation and quality assurance》1998,3(6):256-257
Confidence in laboratory operations is discussed based on the ongoing revision of the ISO/IEC Guide 25. Confidence is a subjective
attribute, which also depends on whose interest is considered. New and better-defined quality systems and technical elements
will be included, and these are beneficial to the transparency of laboratory operations, as well as to the accreditation process.
The ultimate aim is, of course, to satisfy customers. The testing laboratories' industrial customers are, however, generally
unfamiliar with the ISO/IEC Guide 25 and accreditation. The main reason for improved confidence in testing and calibration
laboratories is foreseen to come from closer interaction between laboratories and their customers. 相似文献
14.
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
15.
An optional approach in the meteorological service Quality Management System (QMS) based on the case study of the Republic
Hydrometeorological Service (MHS) of Serbia is presented and discussed in this paper. The idea is to use the ISO/IEC 17025
standard as a base for its QMS development. Main reasons for such a decision and the elements of the implemented solution
are presented and discussed. Meteorological testing processes of the MHS of Serbia and relevant ISO/IEC 17025 scope of accreditation
are presented. After establishing competencies in meteorological, environmental, and hydrological testing, the MHS of Serbia
will develop an integrative ISO 9001 QMS. The Serbian case study could be taken into consideration as one of the options related
to the future World Meteorological Organization Quality Management Framework. 相似文献
16.
L. K. Isaev V. M. Lakhov Y. A. Karpov I. V. Boldyrev B. I. Paneva G. I. Fridman 《Accreditation and quality assurance》1999,4(5):169-173
The history and the present state of the national system for accreditation of analytical laboratories in Russia are described.
Received: 1 September 1998 / Accepted: 1 September 1998 相似文献
17.
Klaus Reber 《Accreditation and quality assurance》1999,4(4):156-157
The Swiss Federal Laboratories for Materials Testing and Research (EMPA) have established a quality assurance system based
on EN 45001 which meets the requirements for accreditation of all EMPA's testing activities. As testing is only a part of
EMPA's range of activities, and is performed in decentralised departments, the system does not satisfy the management needs.
The fundamental reorganisation of EMPA's St. Gallen site was used as an opportunity to implement an overall process-oriented
management system which also included quality and the needs for accreditation. Later, an environmental management system was
added and then certified for ISO 9001 and 14001. The system consists of a "Management Manual" for the St. Gallen site and
a customised "Quality Manual" for each department. One of the key elements is a comprehensive review and planning procedure
covering all business aspects. 相似文献
18.
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
19.
Dean A. Flinchbaugh L. F. Crawford David Bradley 《Accreditation and quality assurance》2001,6(12):493-500
A model is presented that correlates historical proficiency test data as the log of interlaboratory standard deviations versus
the log of analyte concentrations, independent of analyte (measurand) or matrix. Analytical chemistry laboratories can use
this model to set their internal measurement quality objectives and to apply the uncertainty budget process to assign the
maximum allowable variation in each major step in their bias-free measurement systems. Laboratories that are compliant with
this model are able to pass future proficiency tests and demonstrate competence to laboratory clients and ISO 17025 accreditation
bodies. Electronic supplementary material to this paper can be obtained by using the Springer LINK server located at http://dx.doi.org/
10.1007/s007690100398-y.
Received: 31 March 2001 Accepted: 11 September 2001 相似文献
20.
Henry F. Steger 《Accreditation and quality assurance》2002,7(4):134-145
This paper looks back on a quarter century of history of the Council Committee on Reference Materials of the International
Organization for Standardization – REMCO. It begins however with the period before its formation in 1976 to describe how the
Committee came into being as a response to a growing need by the analytical community for the number and variety of reference
materials (RMs) as well as a need for the assurance of the quality of RMs and ends with a view of REMCO activities in the
near future. This is not intended as a detailed history but instead to describe the evolution of REMCO by identifying major
activities and accomplishments of REMCO.
Received: 21 January 2002 Accepted: 22 January 2002 相似文献