ISO TR 22869-2005 Medical laboratories - Guidance on laboratory implementation of ISO 15189 2003《医学实验室 ISO 15189-2003的实验室仪器指南》.pdf
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1、 Reference number ISO/TR 22869:2005(E) ISO 2005TECHNICAL REPORT ISO/TR 22869 First edition 2005-02-15 Medical laboratories Guidance on laboratory implementation of ISO 15189:2003 Laboratoires mdicaux Directives pour la mise en uvre du laboratoire de lISO 15189:2003 ISO/TR 22869:2005(E) PDF disclaime
2、r This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accep
3、t therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the fi
4、le; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2005 All rights
5、 reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the r
6、equester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2005 All rights reservedISO/TR 22869:2005(E) ISO 2005 All rights reserved iiiContents Page Foreword iv Introduction v
7、1 Scope 1 2 Normative references . 1 3 Seeking accreditation for compliance with ISO 15189:2003 1 4 Identifying resources to help a laboratory meet ISO 15189:2003 requirements 1 5 Seeking support for building a quality management system to meet ISO 15189:2003 requirements . 2 6 Implementing a qualit
8、y management system based on ISO 15189:2003 3 6.1 Components of a quality management system . 3 6.2 Assessment Identifying deficiencies in a quality management system. 4 6.3 Planning Correcting deficiencies in a quality management system. 4 6.4 Setting priorities 5 6.5 Implementation Constructing a
9、quality management system. 6 6.6 Evaluating, improving and maintaining the quality management system 6 Annex A (informative) Elements of ISO 15189:2003 for defining a quality management system 7 Bibliography . 14 ISO/TR 22869:2005(E) iv ISO 2005 All rights reservedForeword ISO (the International Org
10、anization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been establi
11、shed has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardizatio
12、n. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
13、Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In exceptional circumstances, when a technical committee has collected data of a different kind from that which is normally published as an International Standard (“state of the art”, for
14、 example), it may decide by a simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not have to be reviewed until the data it provides are considered to be no longer valid or useful. Attention is drawn to the po
15、ssibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TR 22869 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. IS
16、O/TR 22869:2005(E) ISO 2005 All rights reserved vIntroduction This Technical Report provides guidance to laboratories on how to meet the requirements for competence and quality that are particular to medical laboratories contained in ISO 15189:2003 (in the French language, these laboratories are ter
17、med “laboratoires danalyses de biologie mdicale”, while in other languages they might be referred to using a term equivalent to the English “clinical laboratories”). This Technical Report describes the basic principles of a step-by-step process to build and maintain a quality management system withi
18、n a medical laboratory. This Technical Report is equally applicable to newly established and existing laboratories. It encompasses both the management and technical requirements of ISO 15189:2003. It is acknowledged that a country could have its own specific regulations or requirements applicable to
19、 professional personnel, their activities, and their responsibilities in this domain. In countries where accreditation requires adherence to a specific set of requirements, a laboratory seeking such recognition will need to obtain additional guidance from the accreditation body regarding conformity.
20、 This Technical Report also recognizes that each laboratory will be at a different starting point in implementing these requirements. Therefore, each laboratory will need to determine where they are in relationship to building a quality management system that encompasses the various requirements for
21、 medical laboratories. Laboratory management needs to take the first step in building a quality system leading to compliance with ISO 15189:2003 by setting appropriate priorities based on their patient and client needs, their resources, and their local, regional and national mandates. Medical labora
22、tory services are essential to patient care and public health and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients. Such services include arrangements for requisition, patient preparation, patient identification, c
23、ollection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work. Whenever allowed by national regulations, it is
24、 desirable that medical laboratory services include the examination of patients in consultation cases, and that those services actively participate in the prevention of disease in addition to diagnosis and patient management. Each service ought to also provide suitable educational and scientific opp
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