• There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

NEN EN ISO 15189 : 2015

Current
Current

The latest, up-to-date edition.

MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
Published date

12-01-2013

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.

DevelopmentNote
2015 Edition incorporates 2012 Edition + C11. (02/2015)
DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.