What is BS EN ISO 15189 - Quality and competence in medical laboratories about?
This established international standard focuses on quality and competence requirements in medical laboratories. BS EN ISO 15189 can be used by medical laboratories to develop their quality management systems and assess their competence.
What does BS EN ISO 15189 - Quality and competence in medical laboratories cover?
BS EN ISO 15189 specifies requirements for quality and competence in medical laboratories and includes requirements for Point of Care Testing (POCT). As the primary considerations are the welfare of patients and the satisfaction of users, BS EN ISO 15189 contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities.NOTE: International, national, or regional regulations or requirements may also apply to specific topics covered in BS EN ISO 15189:2022.
Who is BS EN ISO 15189 - Quality and competence in medical laboratories for?
- Medical laboratories.
- Healthcare facilities.
- Regulating authorities.
- Accreditation bodies.
Why should you use BS EN ISO 15189 - Quality and competence in medical laboratories?
Medical laboratories can use BS EN ISO 15189 to increase the effectiveness of their management system, thereby improving results and preventing negative effects that could result in harm to patients, laboratory personnel, the public and the environment. Laboratory users, regulatory authorities and accreditation bodies can use BS EN ISO 15189 to confirm or recognize the competence of medical laboratories. This standard can also:
- Facilitate cooperation between medical laboratories and other healthcare services.
- Assist in the exchange of information and in the harmonization of methods and procedures.
- Contribute to waste reduction, minimization of repeat testing and sometimes reduced carbon emissions.
- Increase confidence in medical laboratories.
- Strengthen the risk management of medical laboratories.
What’s new about BS EN ISO 15189?
The 2023 edition, BS EN ISO 15189, brings the standard in line with its parent documents and makes it more focused on patient care.
To find out more, read our article 'Quality management standards for clinical laboratories' here.
