DD-ISO-TS-22367-2008.pdf
《DD-ISO-TS-22367-2008.pdf》由会员分享,可在线阅读,更多相关《DD-ISO-TS-22367-2008.pdf(20页珍藏版)》请在三一文库上搜索。
1、DRAFT FOR DEVELOPMENT DD ISO/TS 22367:2008 Medical laboratories Reduction of error through risk management and continual improvement ICS 11.100.01 ? Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI DD ISO/TS 22367:2008 This Draft for Development was publishe
2、d under the authority of the Standards Policy and Strategy Committee on 30 June 2008 BSI 2008 ISBN 978 0 580 54506 1 National foreword This Draft for Development is the UK implementation of ISO/TS 22367:2008. This publication is not to be regarded as a British Standard. It is being issued in the Dra
3、ft for Development series of publications and is of a provisional nature. It should be applied on this provisional basis, so that information and experience of its practical application can be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience c
4、an be reported to the international organization responsible for its conversion to an international standard. A review of this publication will be initiated not later than three years after its publication by the international organization so that a decision can be taken on its status. Notification
5、of the start of the review period will be made in an announcement in the appropriate issue of Update Standards. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into an international Standard, to extend the
6、 life of the Technical Specification or to withdraw it. Comments should be sent to the Secretary of the responsible BSI Technical Committee at British Standards House, 389 Chiswick High Road, London W4 4AL. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs. A
7、list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Amendments/corrigenda issued since publication DateComments Lic
8、ensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI Reference number ISO/TS 22367:2008(E) TECHNICAL SPECIFICATION ISO/TS 22367 First edition 2008-05-01 Medical laboratories Reduction of error through risk management and continual improvement Laboratoires mdicaux R
9、duction derreurs par gestion du risque et amlioration continue DD ISO/TS 22367:2008 Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI ii Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv I
10、ntroduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 Management responsibility in preventive and corrective actions, and continual improvement . 2 4.1 General. 2 4.2 Management responsibility in preventive actions 2 4.3 Management responsibility in corrective actions . 2
11、4.4 Management responsibility in continuous improvement. 3 5 Identification of potential and actual laboratory non-conformities, errors and incidents 3 6 Classification of laboratory non-conformities, errors and incidents 3 7 Preventive action and corrective actions. 4 8 Assessment of risk arising f
12、rom actual and potential laboratory non-conformities. 5 9 Review of collected laboratory non-conformities, errors and incidents 6 10 Preventive action and corrective action plans 6 11 Preventive action and corrective action plan files 6 12 Continual improvement plan . 6 Annex A (informative) Failure
13、 modes and effects analysis . 7 Annex B (informative) Model for assessing risk of harm. 8 Annex C (informative) Ranking of severity levels. 9 Bibliography. 10 DD ISO/TS 22367:2008 Licensed CopyChinese University of Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI iv Foreword ISO (the Internat
14、ional Organization 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 bee
15、n established 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 stand
16、ardization. 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
17、 voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of document: an ISO Pu
18、blicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreemen
19、t between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an I
20、nternational Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. Attention is drawn to the possibility that some of the elements of this document m
21、ay be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TS 22367 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. DD ISO/TS 22367:2008 Licensed CopyChinese University of
22、Hong Kong, 20/10/2008 08:35, Uncontrolled Copy, (c) BSI v Introduction It is a requirement of ISO 15189 that laboratories have an investigative process to identify aspects that do not conform with their own procedures or with predetermined requirements in the quality management system. ISO 15189 spe
23、cifies that this be linked both to corrective actions and to preventive actions. In addition, it specifies that management review the suitability and effectiveness of the system and its activities in support of patient care, and that they introduce necessary changes. This can best be done by conside
24、ring potential risks introduced at each step of each process. Preventive actions are planned and appropriate anticipatory processes, based upon verifiable information, are undertaken to prevent a potential action from occurring. Corrective actions are similarly planned together with appropriate reac
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- DD ISO TS 22367 2008
链接地址:https://www.31doc.com/p-3752980.html