What is ISO 15189 - Quality and competence requirements in medical laboratories about?
ISO 15189 is an international standard that focuses on quality and competence requirements in medical laboratories. ISO 15189 can be used by medical laboratories in developing their quality management systems and assessing their competence.
Note: International, national or regional regulations or requirements may also apply to specific topics covered in ISO 15189.
Who is ISO 15189 - Quality and competence requirements in medical laboratories for?
ISO 15189 on quality and competence requirements in medical laboratories is useful for:
- Medical laboratories
- Healthcare facilities
- Regulating authorities
- Accreditation bodies
Why should you use ISO 15189 - Quality and competence requirements in medical laboratories?
Medical laboratory services are essential to patient care and therefore must be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients. ISO 15189 specifies requirements for competence and quality that are particular to medical laboratories.
ISO 15189 is acknowledged that a country could have its specific regulations or requirements applicable to some or all its professional personnel and their activities and responsibilities in this domain. ISO 15189 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.