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
Bibliography