Get ISO 15189:2012 Certification
ISO 15189:2012 is an international standard that specifies requirements for the competence and quality of medical laboratories. This standard provides a framework for medical laboratories to establish and maintain a Quality Management System (QMS) that ensures the accuracy and reliability of the results they produce.
Key Principles of ISO 15189:2012
- Patient-Centered Approach: Focus on meeting the needs and expectations of patients, ensuring that laboratory services contribute to the provision of high-quality healthcare.
- Quality Management System (QMS): Implement and maintain a comprehensive Quality Management System that covers all aspects of laboratory activities, from pre-examination to post-examination processes.
- Management Responsibility: Establish clear management responsibilities, including the definition of roles, authorities, and accountability for the effectiveness of the quality management system.
- Documented System: Develop and maintain documented procedures and records that ensure the consistent application of policies, processes, and practices within the laboratory.
- Personnel Competence: Ensure that laboratory personnel are competent, qualified, and properly trained for their roles, fostering a culture of continuous professional development.
.png)
