ISO 7101:2023
Healthcare organization management — Management systems for quality in healthcare organizations — Requirements
The purpose of this document is to provide organizations with requirements to deliver high-quality healthcare and specifies requirements for management systems for quality in healthcare organizations when an organization desires to:
a) demonstrate its ability to consistently meet service user, stakeholder, and applicable statutory and regulatory requirements;
b) enhance service user experience during the continuum of care and continually improve healthcare quality; and
c) create and maintain processes that ensure timely, safe, effective, efficient, equitable, and people-centred care.
The requirements of this document are based on recognized best practices and are intended to be applicable to any organization providing healthcare services, regardless of its type, size, or the services it provides.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of stakeholders
4.3 Determining the scope of the management system for quality in healthcare organizations
4.4 Management system for quality in healthcare organizations
5 Leadership
5.1 Leadership and commitment
5.2 Healthcare quality policy
5.3 Roles, responsibilities and authorities
5.4 Service user focus
5.5 Access to care
6 Planning
6.1 Actions to address risks and opportunities
6.1.1 General
6.1.2 Risk culture
6.1.3 Risk management processes
6.2 Healthcare quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.4.1 General
7.4.2 Service user communication
7.4.3 Clinical communication
7.4.4 External communications
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating documented information
7.5.3 Control of documented information
7.5.4 Information management systems
7.5.5 Control and management of electronic information
7.5.6 Audit of records
8 Operation
8.1 Operational planning and control
8.2 Healthcare facilities management and maintenance
8.2.1 General
8.2.2 Contingency planning for facilities and services
8.2.3 Equipment
8.3 Waste management
8.3.1 General
8.3.2 Waste reduction
8.3.3 Environmental responsibility
8.4 Handling and storage of materials
8.5 Service user belongings
8.6 Emerging technologies
8.7 Service design in healthcare
8.8 Supplies and services from external providers
8.9 Provision of services
8.10 People-centred care
8.10.1 General
8.10.2 Service user experience
8.10.3 Compassionate care
8.10.4 Inclusivity and diversity
8.10.5 Health literacy
8.10.6 Co-production
8.10.7 Workforce wellbeing
8.11 Ethics
8.12 Patient safety
8.12.1 General
8.12.2 Knowledge and learning in safety
8.12.3 Patient identification
8.12.4 Medication safety
8.12.5 Surgical safety
8.12.6 Infection prevention and control (IPC)
8.12.7 Prevention of falls, pressure ulcers and thromboembolism
8.12.8 Diagnostic safety
8.12.9 Blood transfusions
9 Performance evaluation
9.1 Monitoring, measurement, analysis, and evaluation
9.1.1 General
9.1.2 Healthcare quality indicators
9.1.3 Methods
9.1.4 Results
9.2 Internal audit
9.2.1 General
9.2.2 Internal audit programme
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review results
10 Improvement
10.1 Continual improvement
10.2 Nonconformity and corrective action
10.2.1 General
10.2.2 Management of nonconformity and corrective action
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of stakeholders
4.3 Determining the scope of the management system for quality in healthcare organizations
4.4 Management system for quality in healthcare organizations
5 Leadership
5.1 Leadership and commitment
5.2 Healthcare quality policy
5.3 Roles, responsibilities and authorities
5.4 Service user focus
5.5 Access to care
6 Planning
6.1 Actions to address risks and opportunities
6.1.1 General
6.1.2 Risk culture
6.1.3 Risk management processes
6.2 Healthcare quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.4.1 General
7.4.2 Service user communication
7.4.3 Clinical communication
7.4.4 External communications
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating documented information
7.5.3 Control of documented information
7.5.4 Information management systems
7.5.5 Control and management of electronic information
7.5.6 Audit of records
8 Operation
8.1 Operational planning and control
8.2 Healthcare facilities management and maintenance
8.2.1 General
8.2.2 Contingency planning for facilities and services
8.2.3 Equipment
8.3 Waste management
8.3.1 General
8.3.2 Waste reduction
8.3.3 Environmental responsibility
8.4 Handling and storage of materials
8.5 Service user belongings
8.6 Emerging technologies
8.7 Service design in healthcare
8.8 Supplies and services from external providers
8.9 Provision of services
8.10 People-centred care
8.10.1 General
8.10.2 Service user experience
8.10.3 Compassionate care
8.10.4 Inclusivity and diversity
8.10.5 Health literacy
8.10.6 Co-production
8.10.7 Workforce wellbeing
8.11 Ethics
8.12 Patient safety
8.12.1 General
8.12.2 Knowledge and learning in safety
8.12.3 Patient identification
8.12.4 Medication safety
8.12.5 Surgical safety
8.12.6 Infection prevention and control (IPC)
8.12.7 Prevention of falls, pressure ulcers and thromboembolism
8.12.8 Diagnostic safety
8.12.9 Blood transfusions
9 Performance evaluation
9.1 Monitoring, measurement, analysis, and evaluation
9.1.1 General
9.1.2 Healthcare quality indicators
9.1.3 Methods
9.1.4 Results
9.2 Internal audit
9.2.1 General
9.2.2 Internal audit programme
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review results
10 Improvement
10.1 Continual improvement
10.2 Nonconformity and corrective action
10.2.1 General
10.2.2 Management of nonconformity and corrective action
Bibliography