ISO 15189 -standard
ISO 15189 is the quality management standard for medical / clinical laboratories, which places the patient care perspective at its centre.
What is ISO 15189?
The ISO 15189 standard describes the general and technical requirements for medical/clinical laboratories. Compliance with the standard indicates that the organisation is capable of competent, impartial and consistent operation whose focus is on patient care and patient safety.
Kasve’s specialists are experienced in designing, constructing, updating and auditing ISO 15189 compliant quality management systems. We will help you with your quality management needs at the different project stages.
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We have helped a number of medicinal device manufacturers, testing and clinical laboratories, and start-ups develop their operations.