Norma Internacional Iso-15189

INTERNATIONAL STANDARD

ISO 15189
First edition 2003-02-15

Medical laboratories — Particular requirements for quality and competence
Laboratoires d'analyses de biologie médicale — Exigences particulières concernant la qualité et la compétence

Reference number ISO 15189:2003(E)

© ISO 2003

ISO 15189:2003(E)

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© ISO 2003 — All rights reserved

ISO 15189:2003(E)

Contents

Page

Foreword............................................................................................................................................................ iv Introduction ........................................................................................................................................................ v 1 2 3 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8Scope...................................................................................................................................................... 1 Normative references ........................................................................................................................... 1 Terms and definitions........................................................................................................................... 1 Managementrequirements .................................................................................................................. 4 Organization and management ........................................................................................................... 4 Quality management system............................................................................................................... 4 Document control ................................................................................................................................. 6 Review of contracts .............................................................................................................................. 7 Examination by referral laboratories.................................................................................................. 7 External services and supplies ........................................................................................................... 8 Advisory services ................................................................................................................................. 8 Resolution of complaints...