Quality Matters: Harnessing the Power of ISO 15189:2022 for Clinical Diagnostic Labs
Clinical diagnostic labs are one of the key pillars in healthcare for detecting, preventing, and treating diseases. They are responsible for collecting patient samples, delivering precise test results, and ensuring the quality and reliability of medical diagnoses. To meet the increasing demands and complexities of the field, clinical diagnostic labs must comply with global standards that ensure operational quality. ISO 15189 is a globally recognized standard that outlines the requirements for technical competence, quality control, quality assurance, and continual improvement, enabling clinical diagnostic labs to deliver reliable and accurate results consistently.
This ebook provides clinical diagnostic lab professionals with a comprehensive guide on ISO 15189:2022 to harness its use for quality assurance. It delves into the key elements of the standard, its benefits, and practical strategies for successful implementation.
What is included in the eBook:
- What ISO standards are, their history, and the benefits of complying with these standards
- The evolution of ISO 15189
- Understanding ISO 15189:2022, including new terms and notable updates
- Challenges in implementing ISO 15189:2022
- Setting up technical requirements, responsibility and risk management, risk mitigation, and quality management requirements
- Benefits of ISO 15189:2022 certification
- How a healthcare LIMS facilitates compliance with ISO 15189 in clinical diagnostic labs