ISO 15189:2012 - Medical Laboratories

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about ISO 15189:2012

What is the ISO 15189:2012 Certifiaction?

ISO 15189:2012 is an international standard for medical laboratories' competence and quality, specifying requirements for quality management and technical aspects of laboratory services to ensure accuracy and reliability of results.

Key elements of ISO 15189:2012 include:

Quality Management System: Maintaining QMS for testing competence demonstration.

Document Control: Implementing document control procedures for accuracy and availability.

Personnel Competence: Ensuring personnel have required qualifications, training, competence.

Equipment and Facilities: Ensuring equipment and facilities maintain accuracy.

Management Reviews: Regular management reviews for QMS effectiveness, improvement opportunities.

Continuous Improvement: Committing to continuous improvement in laboratory services quality.

What is the goal of ISO 15189:2012?

The primary goal of ISO 15189:2012 is to ensure medical laboratories demonstrate competence, reliability, and accuracy in testing and calibration activities, enhancing patient care and safety.

Who needs ISO 15189:2012 Certifiaction?

ISO 15189:2012 certification is essential for medical laboratories seeking to demonstrate competence, reliability, and accuracy in testing and calibration activities, ensuring patient safety and quality care.

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