When quality management is on the agenda in healthcare organisations, the most pressing issue is clarifying how objectives can be integrated into daily operations. Policies and procedures alone are not sufficient. Processes must be defined, responsibilities assigned, risks monitored, and a system of evidence established.
ISO 9001 and ISO 7101 standards are addressed through the management needs of healthcare organisations. The aim is to clearly outline the areas in which quality management activities can take shape within the organisation.
What Does ISO 9001 Regulate in Healthcare Organisations?
ISO 9001 defines the requirements of a quality management system. The objective in healthcare organisations is to deliver services consistently and to implement an improvement system.
The objectives of implementing ISO 9001 within an organisation are:
- Identifying processes and clarifying process responsibilities,
- Establishing documentation and record-keeping systems,
- Recording and monitoring risks,
- Creating an internal audit plan and managing findings,
- Verifying management decisions with records.
This structure helps establish a common working order in the planning and execution of services.
What does ISO 7101:2023 regulate in healthcare organisations?
ISO 7101:2023 contains requirements for quality management in healthcare services. It defines a systematic approach for healthcare organisations to manage quality in service delivery.
Key management areas in healthcare organisations generally fall under the following categories:
- Ownership by senior management and strengthening of the organisational culture,
- Establishment of a people-centred care approach,
- Identification and management of risks,
- Monitoring of patient safety and staff safety and well-being,
- Documentation of processes and control of services,
- Monitoring and evaluation of performance in clinical and non-clinical processes,
- Implementation of a continuous improvement system.
The critical point here is that the organisation can manage not only clinical processes but also non-clinical processes with a system of records and evidence. Thus, quality management is carried out systematically through planning, monitoring, and improvement steps.
Quality System within the Organisation
To link quality management efforts to a clearer goal, the following three questions are a good starting point. These questions help the organisation strengthen its measurement, monitoring, and evidence system.
- Which indicators are used to monitor patient safety, and what management decisions are based on them?
- Which measurements are used to track employee well-being, and what improvements are planned?
- Which records verify continuity in non-clinical processes?
ISO 9001 manages quality through general processes, while
ISO 7101 defines quality using specific metrics, such as clinical safety, patient experience, and health outcomes, in line with the nature of healthcare services.
Although ISO 7101 is built on ISO 9001, it offers a more in-depth approach to quality management by adding specific requirements tailored to the complexity and people-oriented structure of the healthcare sector.
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