ISO 15189:2012 (QUALITY MANAGEMENT SYSTEM FOR MEDICAL LABORATORIES)
KEY ELEMENTS:
- Committing to Quality and Effective Strategic Planning
- Service Realization: Identifying and Managing Activities
- Resource Management: Applying Established Plans
- Measurement, Analysis & Improvement.
- Ensuring quality of examination results
- Accommodation and environmental conditions
- Laboratory equipment, reagents, and consumables
- Equipment calibration and metrological traceability
INTRODUCTION: ISO 15189 is a medical laboratory management to achieve accreditation based on International standards. The ISO 15189 standard is the first developed especially for accreditation of medical laboratories and emphasizes the laboratory-client interface.
BENEFITS: By Achieving ISO 15189, the management systems by innovative clinical laboratories and pathology groups enables them to drive impressive gains in quality, customer satisfaction and financial performance. This is a key development at a time when medical laboratory budgets are shrinking and more cuts in lab test prices are expected. ISO 15189 accreditation also reduces risks, encourages the sharing of best practices and stimulates innovation. For payers and healthcare providers, accreditation is a tool that provides assurance that clinical lab services are safe, reliable and good value for patients. It also provides a mechanism for measuring quality improvements and supporting consistency. For patients, accreditation gives confidence that the services they receive are competent and safe, which can be a significant selling point for a medical laboratory.
APPLICABLE TO: ISO 15189 is applicable to all medical organizations (Medical Laboratories & Hospitals) that practices in human healthcare field.
