This standard incorporates EN ISO 9001:2015 and adds interpretations, explanations, examples and additional requirements for healthcare organizations. The standard also includes aspects related to clinical risk management throughout the planning, operation and control of processes.
The standard identifies eleven basic quality aspects that by clinical experience are known to be relevant in healthcare organizations. To assess fulfilment of quality requirements the organization need to specify quality characteristics related to these requirements. These aspects are:
- appropriate, correct care
- availability, continuity of care
- effectiveness, efficiency, equity
- evidence/knowledge based care
- patient centred care including physical, psychological and social integrity (ICF)
- patient involvement
- patient safety
- timeliness/accessibility