Wilmington, Delaware – September 14, 2023, CloudLIMS, a leading provider of lab informatics, today published a free, open-access eBook titled “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. Meeting the ISO 15189:2022 guidelines enables clinical diagnostic labs to enhance their overall operations, optimize patient care, and achieve greater efficiency and accuracy of test results.
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
“The ISO 15189 standard is a testament to a lab’s commitment to excellence and positions labs at the forefront of quality-driven healthcare delivery. This complimentary eBook serves as a comprehensive guide, providing clinical diagnostic lab professionals with insights to implement ISO 15189:2022 and, in turn, update laboratory processes to deliver reliable and consistent results,” said Arun Apte, CEO at CloudLIMS. “The book is an invaluable resource for labs seeking to optimize their operations and achieve accreditation for meeting global quality standards,” he continued.
CloudLIMS.com offers a secure, in-the-cloud SaaS LIMS purpose-built for clinical diagnostic labs. CloudLIMS offers a range of complimentary services, including technical support and training, instrument integration, reporting templates, product upgrades, legacy data migration, and automatic data backups. CloudLIMS helps labs maintain user access for PHI control, manage clinical data, automate workflows, and meet compliance such as CLIA, HIPAA, ISO 15189, and EU GDPR. CloudLIMS.com is a SOC 2 Type 2 compliant and ISO 9001:2015 certified informatics company.
Mrinal Kanti Chatterjee