ISO 9001

Nearly one million organisations around the globe are  ISO 9001 certified.It is the world’s most tested and relied upon quality system…..when there is margin for error.In hospitals, ISO is prized for its unique ability to pinpoint and sustain best practice. It is not a product standard, but applicable to any manufacturing or service industry including healthcare.

The standard applies to the processes in an healthcare organisation which have an impact on quality. It emphasises continual improvement and customer (patient) satisfaction. Certification of your quality management system demonstrates your commitment to consistency, continual improvement and customer satisfaction. To be certified, you must implement an effective quality management system complying with the requirements of the standard.

The existing certificate according to ISO 9001:2008 is valid till the expiration of three years from the publication of the revised (new version) standard, no later than 14.09.2018.

EN 15224

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. EN 15224 is based on the requirements ISO 9001: 2008 and provides interpretations and specifications aligned with the context of cure & care. 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.  It defines a total of eleven quality characteristics for health care, and emphasizes that the management of clinical risk is included in all processes for planning, execution, and control.

Requirements have been added and clarified according to the specific health care context. 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.

We provide relevant training and ISO 9001 and EN 15224 certification services.