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ISO 7101: Healthcare Quality Management Systems

Name: ISO 7101: Healthcare Quality Management Systems
Rating: 4.4 (393 reviews)

Design and implement a quality management system for healthcare organizations — patient safety, people-centred care, QMS

Created byCristian Vlad Lupa, rigcert.education

Last updated 5/2026

English

Arabic [Auto],English

What you'll learn

The requirements of ISO 7101:2023
How to ensure patient safety
About the elements of a quality management system in healthcare
What means people-centered care
How to manage risks and opportunities in a healthcare organization

Course content

8 sections • 65 lectures • 5h 42m total length

Introduction4:29
Quality management and the healthcare sector6:22
About the definition of "quality", generic aspects about what is a quality management system and the difference between "effective" and "efficient"
About ISO 71015:16
About the purpose, the intended audience and the structure of ISO 7101:2023
A management system for quality in healthcare organizations9:06
About what is a management system for quality in healthcare, a key aspect for the success of a management system in a healthcare organization and the concept of PDSA (Plan - Do - Study - Act)

Understanding the organization and its context6:47
About the internal and external issues that make up the context of the healthcare organization
Understanding the needs and expectations of stakeholders5:16
About the relevant stakeholders and their needs and expectations
Determining the scope of the management system for quality5:44
About what represents the scope of the management system and what are the requirements of ISO 7101 about the determination of the scope
Management system for quality in healthcare organizations5:23
About the requirements on the establishment, implementation, maintenance and continual improvement of the management system for quality
Recapitulation clause 4 of ISO 7101:20233:39
A recapitulation of the requirements in clause 4 of ISO 7101:2023 - Context of the organization

Leadership and commitment7:17
About the requirements for the top management to demonstrate leadership and commitment with respect to the management system for quality in healthcare
Healthcare quality policy4:15
About the content of the healthcare quality policy and other requirements of ISO 7101 about this document
Roles, responsibilities and authorities6:10
About establishing the relevant roles, responsibilities, authorities and accountabilities for the management system for quality
Service user focus4:15
About the requirements of ISO 7101 on service user focus
Access to care5:34
About the requirements of ISO 7101 on the accessibility of health services, including affordability of services and minimizing the financial risks of service users
Recapitulation clause 5 of ISO 7101:20234:06
A recapitulation of the requirements in clause 5 in ISO 7101:2023 - Planning

Actions to address risks and opportunities8:15
About determining risks and opportunities relevant for the management system for quality
Risk culture3:26
About developing a risk culture in the healthcare organization and what this culture involves
Risk management process8:55
About managing risks and opportunities, including the options available for risk treatment
Healthcare quality objectives and planning to achieve them6:39
About establishing and monitoring healthcare quality objectives
Planning of changes3:34
About planning and implementing changes to the management system for quality
Recapitulation clause 6 of ISO 7101:20233:55
A recapitulation of the requirements in clause 6 of ISO 7101:2023 - Planning

Resources2:58
About the requirements of ISO 7101 on the availability of resources for the management system for quality
Competence5:28
About the process of ensuring an adequate level of competency for the persons who can affect the performance of the management system for quality and the conformity of healthcare services
Awareness2:53
About ensuring that the persons who work for the healthcare organization maintain an adequate level of awareness
Communication6:11
About the internal and external communication processes, including clinical communication and service user communication
Documented information (part 1)7:59
About the different types of documents that the management system for quality include. About creating and updating management system documents and the controls for documented information
Documented information (part 2)6:32
About the information management system, the control and management of electronic information and the audit of records
Recapitulation clause 7 of ISO 7101:20234:05
A recapitulation of the requirements in clause 7 of ISO 7101:2023 (Support)

Operational planning and control5:34
Generic requirements about controlling the processes of the management system for quality
Healthcare facilities management and maintenance6:20
About maintaining the facilities and the physical infrastructure of the healthcare organization
Contingency planning for facilities and services6:09
About the preparations necessary to respond to emergency situations
Equipment4:18
About the requirements of ISO 7101 on the maintenance of the necessary equipment to provide healthcare services
Waste management6:36
About managing the different categories of wastes generated by the healthcare organization
Handling and storage of materials4:13
The requirements of ISO 7101 on the handling and storage of the products and materials needed to provide healthcare services
Service user belongings4:04
About managing the goods that service users may bring to the healthcare facility
Emerging technologies4:53
The requirements of ISO 7101 for when new technologies (like robots, cobots, digital platforms or artificial intelligence) are used to deliver healthcare services
Service design in healthcare6:35
The requirements for designing new healthcare services of making significant changes to the existing services
Supplies and services from external providers5:54
About the requirements of ISO 7101 about products and services from external suppliers, including the evaluation and selection of providers
Provision of services7:27
About the requirements of ISO 7101 on the provision of safe, effective, efficient and timely healthcare services
People-centered care2:26
About the concept of people-centered care and what it involves
Service user experience6:36
About assessing service user experience, collecting feedback from patients and using this information to improve the services
Compassionate care4:20
About what means compassionate care and how the healthcare organization should develop an environment that emphasises compassion
Inclusivity and diversity2:58
About the requirements of ISO 7101 for fostering inclusivity and diversity
Health literacy2:51
About the efforts that the healthcare organization shall make to educate its workforce and services users to be health literate
Co-production3:29
About co-producing health services and how is the organization expected to involve stakeholders in the design and provision of services
Workforce wellbeing5:42
About the requirements of ISO 7101 for protecting the health and safety and promoting the wellbeing of workers
Ethics4:53
About managing ethical dilemmas and ethical concerns, including human subject research
Patient safety4:35
About the aspects that the healthcare organization shall focus on to ensure patient safety
Knowledge and learning in safety2:19
About the requirements for learning and the development of knowlege in safety matters
Patient identification3:16
About the system that the healthcare organization should apply to identify correctly its patients
Medication safety4:20
About the requirements of ISO 7101 that refer to medication safety, including the prevention of errors and adverser reactions
Surgical safety4:18
About the requirements for ensuring the safety of patients while undertaking surgical procedures
Infection prevention and control7:01
About the requirements of ISO 7101 for the prevention and control of healthcare-acquired infections
Prevention of falls, pressure ulcers and thromboembolism4:02
Requirements to ensure the safety of patients in relation to the risks of falls, pressure injuries and thromboembolsim
Diagnostic safety4:51
Requirements for diagnostic safety to ensure accurate and timely laboratory testing, pathology, and imaging services
Blood transfusions6:31
The requirements of ISO 7101 on blood transfusions including donor education, cross-matching or screening for transfusion-transmissible diseases
Recapitulation clause 8 of ISO 7101:20236:36
A recapitulation of the requirements in ISO 7101, clause 8 - Operation

Monitoring, measurement, analysis and evaluation4:27
About the healthcare quality monitoring system of the organization, about establishing quality indicators
Internal audit7:39
The requirements of ISO 7101 for the internal audits of the management system for quality in a healthcare organization
Management review7:07
The requirements of ISO 7101 about the management review, including the input elements and the expected results of the management review
Recapitulation clause 9 of ISO 7101:20233:26
A recapitulation of the requirements in clause 9 of ISO 7101 - Performance evaluation

Continual improvement4:42
About the requirements of ISO 7101 for improving continually the suitability and adequacy of the management system for quality in healthcare
Management of nonconformity and corrective action7:58
About managing nonconformities and addressing their effects and their causes with corrections and corrective actions, respectively
Certification according to ISO 71014:35
About the certification process for a management system for quality in healthcare and about the certification of individuals as evidence of their competence in quality management
Thank you and good bye!4:44
A few thoughts at the end of the course
ISO 7101:2023. Quality management in healthcare organizations

Requirements

Familiarity with quality management concepts is useful, but not mandatory

Description

ISO 7101 is the world's first international standard for quality management systems in healthcare organizations.

Published in 2023, it defines the requirements for a healthcare quality management system built around people-centred care, patient safety and continual improvement — applicable to any organization delivering healthcare services, from hospitals and clinics to laboratories, care homes and telehealth providers.

This course offers an in-depth exploration of ISO 7101 and equips you with the knowledge and tools to enhance quality of care, patient safety, cost-effectiveness and reputation in a healthcare institution.

You will understand what people-centred care means in practice, what a healthcare organization must focus on to ensure patient safety, how risks and opportunities are managed, and what documentation supports the effective operation of a healthcare quality management system.

Course structure

An introductory section covering how quality is defined in healthcare, what a quality management system (QMS) is, and the benefits of adopting one in a healthcare organization
The following sections mirror the clauses of ISO 7101:2023:
- Context of the organization (Clause 4)
- Leadership (Clause 5)
- Planning (Clause 6)
- Support (Clause 7)
- Operation (Clause 8)
- Performance evaluation (Clause 9)
- Improvement (Clause 10)

Course highlights

Comprehensive coverage of the requirements of ISO 7101:2023
Practical solutions for implementing a healthcare quality management system
Detailed explanations of healthcare risk management, quality policy and objectives, documentation control, ethics in healthcare, patient safety, waste management and environmental responsibility, service design, facilities maintenance, internal audits, management review and handling nonconformities
The certification process — both for a healthcare organization seeking ISO 7101 certification and for quality management professionals

Who this course is for

Quality managers and quality coordinators in hospitals, clinics and other healthcare organizations
Healthcare administrators and managers responsible for patient safety and service quality
Doctors, nurses and clinical staff involved in quality improvement initiatives
Quality professionals from other sectors (ISO 9001) moving into healthcare
Consultants and auditors extending their scope to healthcare quality management

Whether your organization is considering ISO 7101 certification or you want to build expertise in healthcare quality management, this course gives you a clear, structured and practical understanding of the standard.

Who this course is for:

Quality managers
QMS auditors and consultants
Healthcare quality professionals
Healthcare risk managers
Healthcare educators
Quality management professionals

ISO 7101: Healthcare Quality Management Systems

What you'll learn

Explore related topics

Course content

Introduction4 lectures • 25min

Context of the organization (clause 4)5 lectures • 27min

Leadership (clause 5)6 lectures • 32min

Planning (clause 6)6 lectures • 35min

Support (clause 7)7 lectures • 36min

Operation (clause 8)29 lectures • 2hr 23min

Performance evaluation (clause 9)4 lectures • 23min

Improvement (clause 10)4 lectures • 22min

Requirements

Description

Who this course is for: