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
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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
25、ortunities for its professional staff. While this Technical Report is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other health services and disciplines could also find it useful and appropriate. In addition, accreditation bodies t
26、hat recognize the competence of medical laboratories may be able to use this Technical Report as the basis to assist laboratories in meeting requirements to establish a quality management system. International, national or regional guidance documents may also help a laboratory in meeting both local
27、requirements as well as those in ISO 15189:2003. This Technical Report provides guidance on how the requirements of ISO 15189:2003 fit within a medical laboratorys quality management system and on the relationship between various ISO documents that concern building a quality management system and IS
28、O 15189:2003. A detailed outline of how the elements of ISO 15189:2003 help define a quality management system is provided in Annex A. Finally, links to additional resources materials, including international and national standards setting and accreditation bodies, are provided in the Bibliography.
29、TECHNICAL REPORT ISO/TR 22869:2005(E) ISO 2005 All rights reserved 1Medical laboratories Guidance on laboratory implementation of ISO 15189:2003 1 Scope This Technical Report provides guidance to medical laboratories describing how a medical laboratory can implement a quality system to meet the spec
30、ific technical and management requirements for quality and competence in ISO 15189:2003. Bodies engaged in the recognition of the competence of medical laboratories may also be able to use this Technical Report as a basis to assist laboratories in establishing a quality system to meet national requi
31、rements, while at the same time conforming to appropriate International Standards. This guidance applies both to newly established and existing laboratories and encompasses both the management and technical requirements of ISO 15189:2003. 2 Normative references The following referenced documents are
32、 valuable resources for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 15189:2003, Medical laboratories Particular requirements for quality and compe
33、tence (corrected and reprinted in July 2003) 3 Seeking accreditation for compliance with ISO 15189:2003 If accreditation to ISO 15189:2003 is the ultimate goal, seeking the advice of experts can help a laboratory avoid many of the pitfalls of either inadequate preparation or wasted effort. A prelimi
34、nary audit of where the laboratory is on its pathway to building a quality management system and accreditation to a standard can be extremely helpful. A laboratory already adhering to best technical and management medical laboratory practices may only have to document its practices, while a laborato
35、ry just starting on the path of building a quality management system needs to recognize the time and resources required to achieve the goal of accreditation. The focus of this Technical Report is to help a laboratory put in place a management system that will address both the management and technica
36、l requirements of ISO 15189:2003. As management implements a quality management system, it is necessary for management to consider ways to meet the technical requirements for personnel, environment conditions, equipment, and pre-examination, examination, and post-examination procedures described in
37、the ISO 15189:2003. 4 Identifying resources to help a laboratory meet ISO 15189:2003 requirements Each laboratory is likely to have a unique set of resources available to assist it in meeting requirements. Laboratory management can generally find help from other local laboratories who have already a
38、chieved compliance with requirements, or from professional laboratory organizations (local, regional, national and international), or from government, accrediting bodies (where permitted or provided), or international organizations offering quality assurance support for medical laboratories or from
39、a consultant with appropriate expertise. If a laboratory is uncertain about a place to start, the countrys Ministry of Health, or equivalent ISO/TR 22869:2005(E) 2 ISO 2005 All rights reservednational health organization may be the best place to begin. Also, refer to the Bibliography for additional
40、resource materials. 5 Seeking support for building a quality management system to meet ISO 15189:2003 requirements Laboratory management should recognize that there is a hierarchy of concepts used to describe a quality management system for health care services. These concepts, arranged from a manag
41、ers perspective, begin with a total quality management philosophy, which strives to achieve quality (safe, effective, timely and patient-oriented) service within the health care delivery system. This philosophy generally encompasses quality management, which strives to maintain coordinated and compr
42、ehensive efforts to meet the quality objectives of the health care system. These efforts are referred to as the “quality system”, which includes all of the quality assurance activities (part of quality management focused on providing confidence that quality requirements will be fulfilled) (ISO 9000:
43、2000) as well as quality control activities (part of quality management focused on fulfilling quality requirements) (ISO 9000:2000) (see Figure 1). Figure 1 The quality pyramid In the absence of this hierarchal quality management scheme (quality pyramid) a laboratory may achieve highly accurate and
44、reliable testing results that meet all of its analytical goals, but fail to deliver needed patient care results because of other flaws in the delivery of services in the health care system. For example, if the wrong test is performed on the correct patient sample or if the right test is performed on
45、 the wrong patient sample, the laboratory examination may be detrimental to patient care even if the results are analytically accurate and reliable. Since it is necessary that the quality system respond to a constantly changing health care environment, it is necessary for laboratory management to de
46、velop a plan for continuous improvement of its management practices (including staff training), and quality assurance, and quality control procedures to maintain a high level of readiness to respond to medical needs. Benefits of implementing a quality management system can include better resource al
47、location and reductions in operational costs. Accreditation to ISO 15189:2003 incorporates and defines essential elements in the quality management system for medical laboratories. If a laboratory wants to be recognized as an organization that meets worldwide standards for quality, it needs to compl
48、y with this set of requirements. Achieving compliance within a framework of a quality system allows stepwise progress towards the goal of compliance with ISO 15189:2003, without wasting precious resources. A laboratory should stress to whomever it is accountable that their goal is to provide adequat
49、e laboratory service to support health care needs. Accomplishing compliance with ISO 15189:2003 within a quality management system permits an efficient way to meet service delivery and patient care goals. By implementing a quality management system the quality in an entire cycle of delivery of laboratory services can be assured (see Figure 2). It is necessary that this cycle be continuously examined for opportunities to improve laboratory services, for example, by reducing the number of samples the laboratory receives that are inadequate
