医学实验室质量要求资料精.pdfVIP

NATIONAL PATHOLOGY ACCREDITATION ADVISORY COUNCIL REQUIREMENTS FOR QUALITY MANAGEMENT IN MEDICAL LABORATORIES (2007 Edition) ISBN: 1 74186 160 8 Online ISBN: 1 74186 161 6 Publications Approval Number: 3958 © Commonwealth of Australia 2007 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth available from the Department of Communications, Information Technology and the Arts. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Intellectual Property Branch, Copyright Law Branch, Attorney-General’s Department, Robert Garran Offices, National Circuit, Baron ACT 2600 or posted at .au/cca First published 2001 Second edition 2007 reprinted with major revisions and name change from Guidelines for Quality Systems in Medical Laboratories Publications Production Unit Australian Government Department of Health and Ageing ii Requirements for Quality Management in Medical Laboratories Contents Introduction1 G1 Organisation and management2 G2 Quality management system5 G3 Document control8 G4 Review of contracts for medical test requests10 G5 Examination by referral laboratories13 G6 External services and supplies15 G7 Advisory services17 G8 Resolution of complaints19 G9 Identification and control of nonconformities 21 G10 Corrective action23 G11 Preventive action27 G12 Continual improvement29 G13 Quality and technical records31 G14 Internal audits33 G15 Management review37 Bibliography39 Requirements for Quality Management in Medical Laboratories iii National Path