NEN EN ISO 15189 : 2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
  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
5 Technical requirements
  5.1 Personnel
  5.2 Accommodation and environmental conditions
  5.3 Laboratory equipment
  5.4 Pre-examination procedures
  5.5 Examination procedures
  5.6 Assuring quality of examination procedures
  5.7 Post-examination procedures
  5.8 Reporting of results
Annex A (normative) - Correlation with ISO 9001:2001 and
                        ISO/IEC 17025:1999
Annex B (informative) - Recommendations for protection of
                        laboratory information systems (LIS)
Annex C (informative) - Ethics in laboratory medicine
Bibliography

Defines requirements for quality and competence in medical laboratories.