Key benefits of ISO 15189
Introduction
This International Standard, based upon ISO/IEC 17025 and ISO 9001, specifies requirements for competence and quality that are particular to medical laboratories). 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.
Medical laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients. Such services include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.
Whenever allowed by national, regional or local regulations and requirements, it is desirable that medical laboratory services include the examination of patients in consultation cases, and that those services actively participate in the prevention of disease in addition to diagnosis and patient management.
Each laboratory should also provide suitable educational and scientific opportunities for professional staff working with it.
While this International Standard 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 could also find it useful and appropriate. 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. If a laboratory seeks accreditation, it should select an accrediting body which operates in accordance with ISO/IEC 17011 and which takes into account the particular requirements of medical laboratories.
This International Standard is not intended to be used for the purposes of certification, however a medical laboratory’s fulfilment 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. The management system requirements in Clause 4 are written in a language relevant to a medical laboratory’s operations and meet the principles of ISO 9001:2008, Quality management systems — Requirements, and are aligned with its pertinent requirements (Joint IAF-ILAC-ISO
Communiqué issued in 2009).
The correlation between the clauses and subclauses of this third edition of ISO 15189 and those of ISO 9001:2008 and of ISO/IEC 17025:2005 is detailed in Annex A of this International Standard.
Environmental issues associated with medical laboratory activity are generally addressed throughout this International Standard, with specific references in 5.2.2, 5.2.6, 5.3, 5.4, 5.5.1.4 and 5.7.
Basic requirements
The difference between ISO 9001 and ISO 15189 approach is that ISO 15189 is direct presence of medical technical laboratory requirements. The 15189 framework provides a quality management system close to the ISO 9001:2008 management requirements, supplemented by specifications for technical competence that are unique to medical laboratories.
ISO 15189 technical requirements are applied for personnel, accommodation and environmental conditions, laboratory equipment, reagents, and consumables, pre-examination processes, examination processes, ensuring the quality of testing processes results, post-examination processes, reporting of results, the release of results, and laboratory information management.
Advantages for ISO 15189
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The only global standard for the accreditation of medical laboratory results.
- Based on good laboratory practices.
- Focused on technical specifications in medical laboratory.
- Process approach matching the pre-analytical, analytical, and post-analytical phases.
- Oriented to support accurate clinical decisions.
- Identification and traceability information of the different phases of the medical laboratory process.
- Monitoring and measuring of devices that significantly contribute to the trueness and uncertainty of the reported results.
- Training and competence assessment of the staff which is critical to good management and good laboratory practices, and infrastructure to correctly support the operation practices.
Our services
Certification – We provide assessment and certification to ISO 15189 Industrial Standards.
Gap analysis & preliminary assessments – We offer gap analysis and preliminary assessments to prepare you for certification.
Training – TATC provides on-site introduction and internal audit training which will prepare you and your staff prior to and after the certification process.