Quality Management and Risk Management

The following committees are responsible for the drafting of standards on quality management and risk management for the below listed areas:

Acronym

Name

Notes

NA 063-01-10 AA

Quality management systems in health care facilities

quality management systems for e.g. hospitals, medical practices, nursing homes, pharmacies - currently inactive

NA 063-01-13 AA

Quality management and corresponding general aspects for medical devices

quality management systems for production

of medical devices, risk management

NA 063-02-11 AA

Quality management systems for primary packaging

quality management systems for primary packaging materials for pharmaceutical and medical applications, taking into account Good Manufacturing Practice (GMP) - currently inactive

NA 063-03-03 AA

Quality management in medical laboratories

NA 080-00-05 AA

Radiotherapy

DKE/UK 811.3

Safety of medical devices/systems/facilities in the networked application

application of risk management to IT network in medical equipment, networks in operating rooms and clinics, software and security





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