ISO 7101:2023 Healthcare organization management — Management systems for quality in healthcare organizations — Requirements is the international standard for healthcare quality management. It provides requirements for a quality management system for healthcare organizations.
Who should use the standard?
The target audience is broad, including any healthcare system, organization, or entity that aims to increase the quality of its healthcare delivery and care outcomes. This includes ministries of health, public and private healthcare systems, hospitals, clinics, non-governmental organizations and agencies that provide healthcare services.
What is its purpose?
The purpose of the standard is to enable healthcare organizations deliver high-quality healthcare by specifying requirements for healthcare quality management systems (HQMS) that:
- demonstrate the organisation’s ability to consistently meet service user, stakeholder, and applicable statutory and regulatory requirements;
- enhance service user experience during the continuum of care and continually improve healthcare quality; and
- 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 to:
- create a culture of quality starting with strong top management;
- embrace a healthcare system based on people-centred care, respect, compassion, co-production, equity and dignity;
- identify and address risks;
- ensure patient and workforce safety and wellbeing;
- control service delivery through documented processes and documented information;
- monitor and evaluate clinical and non-clinical performance;
- continually improve its processes and results.
What does it cover?
| 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 |
| 6.2 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 |
| 7.5 Documented information |
| 8 Operation |
| 8.1 Operational planning and control |
| 8.2 Healthcare facilities management and maintenance |
| 8.3 Waste management |
| 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 |
| 8.11 Ethics |
| 8.12 Patient safety |
| 9 Performance evaluation |
| 9.1 Monitoring, measurement, analysis, and evaluation |
| 9.2 Internal audit |
| 9.3 Management review |
| 10 Improvement |
| 10.1 Continual improvement |
| 10.2 Nonconformity and corrective action |
What are the steps in implementing ISO 7101?
Implementing a management system for quality in healthcare organizations in conformity with ISO 7101 involves a number of steps.
1. Leadership and Commitment
- Secure commitment from top management to implement and support the HQMS in accordance with ISO 7101.
- Appoint a Quality Manager or Coordinator to lead the implementation efforts.
2. Scope Determination
Define the scope of the HQMS, including the services, departments, and locations that will be covered by ISO 7101 compliance.
3. Quality Policy and Objectives
- Develop a quality policy that reflects the organization’s commitment to high-quality healthcare services and compliance with ISO 7101.
- Set specific, measurable, achievable, relevant, and time-bound (SMART) quality objectives.
4. Stakeholder Engagement
- Identify and engage key stakeholders, including patients, staff, suppliers, and regulatory bodies.
- Establish effective communication channels to address stakeholder needs and expectations.
5. Legal and Regulatory Compliance
Ensure that the organization is aware of and complies with all applicable healthcare laws, regulations, and standards.
6. Risk Management
- Conduct risk assessments to identify potential risks to patient safety and service quality.
- Develop and implement risk management strategies to mitigate identified risks.
7. Resource Management
- Identify and allocate the necessary resources, including personnel, equipment, and infrastructure, to support the HQMS.
- Ensure that staff are appropriately trained and competent.
8. Process Mapping and Documentation
- Map out all critical healthcare processes and workflows.
- Develop and maintain documentation, including standard operating procedures (SOPs), work instructions, and quality manuals.
9. Patient Care and Safety
- Implement procedures to ensure patient safety and high-quality care.
- Establish mechanisms for monitoring patient outcomes and addressing patient concerns and complaints.
10. Monitoring and Measurement
- Define Key Performance Indicators (KPIs) and metrics to assess the performance of the HQMS.
- Implement monitoring and reporting systems to track quality performance.
11. Internal Audits and Reviews
- Conduct regular internal audits to assess compliance with ISO 7101 and the effectiveness of the HQMS. You can check if you are working in conformity with this standard by using a self-audit tool. You can download your free copy from here (.pdf).
- Review audit findings and implement corrective actions as needed.
12. Continual Improvement
- Foster a culture of continual improvement by encouraging staff to suggest and implement enhancements to healthcare practices.
- Use the Plan-Do-Check-Act (PDCA) cycle for continual improvement.
13. Incident and Complaint Management
- Develop procedures for reporting and investigating incidents, adverse events, and patient complaints.
- Implement corrective and preventive actions to address identified issues.
14. Management Review
- Hold periodic management reviews to evaluate the performance of the HQMS and identify areas for improvement.
- Ensure that management reviews consider the results of audits, patient feedback, and performance data.
15. External Audit and Certification
Engage with a certification body to perform an external audit to assess the HQMS’s conformity with ISO 7101.
16. Certification and Maintenance
- After successfully passing the certification audit, the organization will be granted ISO 7101 certification.
- Maintain and continually improve the HQMS to ensure ongoing compliance.
Some further words of advice…
It is essential to recognize that ISO 7101 compliance is an ongoing process. Organizations should continually monitor and measure their healthcare quality performance, adapt to changing healthcare risks and regulations, and actively promote a culture of quality and patient safety. Regularly review and update the HQMS’s policies, objectives, and procedures to ensure they remain relevant and effective.
ISO 7101:2023 can be purchased through the ISO.org website.
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