BS EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence

BS EN ISO 15189:2012

Medical laboratories. Requirements for quality and competence

Status : Current, Under review   Published : November 2012
Conformity to regulation : Designated



Medical laboratory services are essential to patient care and therefore must meet the needs of all patients and the clinical personnel responsible for their care.

To help achieve this, BSI has developed BS EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence which specifies the needs for quality and competence within medical laboratories.

This International Standard can be applied by medical laboratories to develop their quality management systems whilst assessing their own competence. It can also be used for recognizing the proficiency of medical laboratories by customers, regulating authorities and accreditation bodies.

BS EN ISO 15189:2012 is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines such as clinical physiology, medical imaging and medical physics may also find it useful. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities.

The standard offers insight into the arrangements for:

  • Examination requests
  • Patient preparation & identification
  • Collection of samples
  • Transportation storage 
  • Safety & ethics in medical laboratory work.

It is acknowledged that a country could have its own specific regulations or requirements applicable to some or all its professional personnel and their activities and responsibilities in this domain.

Whilst this International Standard is not intended to be used for the purposes of certification; however a medical laboratory’s fulfillment of the requirements of this International Standard means the laboratory meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid results. 

Contents Page

1 Introduction
2 Normative references
3 Terms and definitions
4 Management requirements
4.1 Organization and management responsibility
4.2 Quality management system
4.3 Document control
4.4 Service agreements
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 Control of records
4.14 Evaluation and audits
4.15 Management review
5 Technical requirements
5.1 Personnel
5.2 Accommodation and environmental conditions
5.3 Laboratory equipment, reagents, and consumables
5.4 Pre-examination processes
5.5 Examination processes
5.6 Ensuring quality of examination results
5.7 Post-examination processes
5.8 Reporting of results
5.9 Release of results
5.10 Laboratory information management
Annex A (informative) Correlation with ISO 9001:2008 and ISO/IEC 17025:2005
Annex B (informative) Comparison of ISO 15189:2007 to ISO 15189:2012

Standard NumberBS EN ISO 15189:2012
TitleMedical laboratories. Requirements for quality and competence
StatusCurrent, Under review
Publication Date30 November 2012
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)ISO/IEC Guide 2, ISO/IEC 17025:2005, ISO/IEC Guide 99, ISO/IEC 17000
Informative References(Provided for Information)ISO/TS 22367, CLSI C24-A3, CLSI H26-A2, ISO 15194, CLSI C28-A3, CLSI C54-A, ISO 15190, CLSI GP35-P, ISO 3534-1, CLSI GP26-A4, CLSI M29-A3, CLSI GP32-A, CLSI GP17-A2, CLSI GP27-A2, CLSI EP17-A, ISO/IEC 27001, ISO/IEC 17011, CLSI GP29-A2, ISO 1087-1, ISO 9000:2005, CLSI H57-A, CLSI GP09-A, CLSI EP15-A2, CLSI GP02-A5, ISO Guide 30, CLSI I/LA33-P, CLSI GP21-A3, CLSI C03-A4, ISO/IEC 80000, CLSI X05-R, CLSI GP31-A, ISO 5725-1, EN 1614:2006, BS EN ISO 19011:2018, EN 12435:2006, ISO 19011:2018, CLSI GP29-A, CLSI GP37-A, CLSI GP18-A2, ISO/IEC 17043:2010, CLSI GP33-A, ISO 27799, CLSI H04-A6, CLSI H18–A4, CLSI AUTO08-A, CLSI H03-A6, ISO 22870:2006, CLSI GP16-A3, CLSI GP22-A3, ISO 9001:2008, ISO 19011, CLSI AUTO10-A
ReplacesBS EN ISO 15189:2007
Amended ByCorrigendum, October 2014
DescriptorsQuality, Laboratory testing, Medical sciences, Medical technology, Quality management, Quality assurance, Laboratory accreditation, Laboratories, Medical laboratory equipment, Quality assurance systems, Management
Title in FrenchLaboratoires de biologie médicale. Exigences concernant la qualité et la compétence
Title in GermanMedizinische Laboratorien. Anforderungen an die Qualität und Kompetenz
ISBN978 0 580 88018 6
File Size1.912 MB

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