You want to manage your processes and implement efficient quality management system, but you feel ISO 9001 does not meet your expectations?
EN 15224, also known as ‘ISO 9001 for the Healthcare’ is a quality management standard, intended for all organizations in the healthcare sector. This is a stand-alone document and can be used for multi-disciplinary certification in health care.The requirements in this standard incorporate those from EN ISO 9001 with additional interpretations and specifications for health care.
This standard also includes aspects related to clinical risk management throughout the planning, operation and control of processes.
Cross border healthcare is becoming increasingly important within Europe. The application therefore extends far beyond the medical activity, namely to detect diseases to cure, mitigate or prevent them, also on the care, physiotherapy and health. The EN 15224 can be used to certify health care organizations in the European conformity assessment procedure.
If you are with a healthcare organization currently certified to ISO 9001 or one considering certification to the EN 15224 standard, AACI can help keep you up to date with the important changes to structure and requirements.
Meeting EN 15224 requirements is an accomplishment recognised with the awarding of AACI’s Blue Mark of Certification.