Section 4 - Management requirements

Section 4 of ISO 15189 is essentially ISO 9001 interpeted for a medical laboratory. The contents include:
4.1 Organization and management
4.2 Quality management system
4.3 Document control
4.4 Review of contracts
4.5 Examination by referral laboratories
4.6 External services and supplies
4.7 Advisory services
4.8 Resolution of complaints
4.9 Identification and control of nonconformities
4.10 Corrective action
4.11 Preventive action
4.12 Continual improvement
4.13 Quality and technical records
4.14 Internal audits
4.15 Management review

ISO 15189:2003

Medical laboratories - Particular requirements for quality and competence

ISO 15189 is based upon ISO/IEC 17025 and ISO 9001. It provides the requirements for competence and quality in a medical laboratory.