As iso 15189 2009 medical laboratories - particular requirements for quality and competence
AS ISO 15189—2009 ISO 15189:2007 AS ISO 15189—2009 Australian Standard®This is a free 7 page sample. Access the full version online. Medical laboratories—Particular requirements for quality and competence
This Australian Standard® was prepared by Committee HE-029, Clinical Laboratory Testing and In Vitro Diagnostic Test Systems. It was approved on behalf of the Council of Standards Australia on 21 July 2009. This Standard was published on 11 August 2009. The following are represented on Committee HE-029: • Australasian Association of Clinical Biochemists • Australian Association of Pathology Practices • Australian Institute of Medical Scientists • Australian Society for Microbiology • Consumers Federation of Australia • Human Genetics Society of Australasia • Medical Technology Association of Australia • National Association of Testing Authorities Australia • National Coalition of Public Pathology • National Pathology Accreditation Advisory Council •This is a free 7 page sample. Access the full version online. Royal College of Pathologists of Australasia • Therapeutic Goods Administration Additional Interests: • Ausbiotech This Standard was issued in draft form for comment as DR AS ISO 15189. Standards Australia wishes to acknowledge the participation of the expert individuals that contributed to the development of this Standard through their representation on the Committee and through the public comment period. Keeping Standards up-to-date Australian Standards® are living documents that reflect progress in science, technology and systems. To maintain their currency, all Standards are periodically reviewed, and new editions are published. Between editions, amendments may be issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current Standard, which should include any amendments that may have been published since the Standard was published. Detailed information about Australian Standards, drafts, amendments and new projects can be found by visiting www.standards.org.au Standards Australia welcomes suggestions for improvements, and encourages readers to notify us immediately of any apparent inaccuracies or ambiguities. Contact us via email at firstname.lastname@example.org, or write to Standards Australia, GPO Box 476, Sydney, NSW 2001.
ii ii PREFACE This Standard was prepared by the Standards Australia Committee HE-029, Clinical Laboratory Testing and In Vitro Diagnostic Test Systems to supersede AS 4633—2004. This Standard is identical to, and has been reproduced from ISO 15189:2007, Medical laboratories—Particular requirements for quality and competence. The objective of this Standard is to provide requirements for quality and competence that are particular for medical/clinical laboratories. As this Standard is reproduced from an International Standard, the following modifications apply: (a) Its number does not appear on each page of the text, and its identity is shown only on the cover and title page. (b) In this reproduced text, ‘this International Standard’ should be read as ‘this Australian Standard’.This is a free 7 page sample. Access the full version online. The reference to International Standards should be replaced by references to the following Australian or Australian/New Zealand Standards: Reference to International Standard or other Australian Standard/New Zealand Standard publication ISO AS 31 Quantities and units (all parts) 2900 Quantities and units (all parts) AS/NZS ISO 9000 Quality management systems— 9000 Quality management systems— Fundamentals and vocabulary Fundamentals and vocabulary 9001 Quality management systems— 9001 Quality management systems— Requirements Requirements ISO/IEC AS/NZS ISO 17025 General requirements for the 17025 General requirements for the competence of testing and competence of testing and calibration laboratories calibration laboratories Guide 43-1 Proficiency testing by HB 18.43.1 Guidelines for third-party interlaboratory comparisons certification and accreditation Part 1: Development and Guide 43: Proficiency testing by operation of proficiency testing interlaboratory comparisons— schemes Part 1: Development and operation of proficiency testing schemes International vocabulary of basic and general — terms in metrology (VIM). BIPM, CLSI, IEC, IFCC, ISO, IuPAC, IUPAP, OIML The term ‘informative’ has been used in this Standard to define the application of the annex to which it applies. An ‘informative’ annex is for information or guidance only.
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