ISO 7101: Healthcare Quality Management Systems (Udemy.com)
Design and implement a quality management system for healthcare organizations — patient safety, people-centred care, QMS
Created by: Cristian Vlad Lupa
Last updated July 2026
What you will 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
How it compares
Against the other 1,210 rated Udemy courses in Business on CourseDuck:
- Rating4.5 out of 5higher than 46% of them
- Reviews414#708 of 1,211 by number of reviews
- Length5.7 hourslonger than 74% of them
- Last updatedJuly 2026more recently than 78% of them
Course 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.
Instructor Details
- 4.5 Rating
414 Reviews
Cristian Vlad Lupa
Who am I?
I’ve been working in the field of standards, auditing, and certification since the early 2000s. Over the years, I’ve contributed to hundreds of projects across various industries and disciplines. Today, I work with RIGCERT, an accredited certification body based in Europe.
What do I do?
I translate the knowledge and best practices from international standards and recognized compliance frameworks into clear, practical language — to help individuals and organizations improve.
How do I teach?
I design and record every course myself. You will be learning from a human instructor with real-world auditing experience — not from AI-generated content. Since launching my first course in 2016, my focus has always been on extracting the core ideas from complex subjects and delivering them in a clear, concise format. I only build and publish courses that I myself would take.
What are my interests?
My work spans quality management, information security, data protection and privacy, artificial intelligence governance, risk management, business continuity, occupational health and safety, environmental management, energy management, compliance, food safety, and others.
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Reviews
By Cassie Cook on 6/3/2026
It's a great overview for someone like me, who is interested in an auditing career focused on healthcare in particular!
By Gorbanovschi Cristina on 2/12/2026
Very detailed information about ISO 7101. More than I expected. I already started to apply new requirements in practice. Thank you very much!
By Abdullah Omer Baali on 6/23/2025
As a quality and institutional excellence manager in a health facility, I find that I am close to understanding the requirements of the items in practice and in the skills of ISO for total quality
By Rafael Gerardo Rivero Zepeda on 5/28/2025
le falta más contexto y le falta más material descargable, la presentación parece buena pero no tiene bibliografía para poder hacer una implementación más a fondo respecto a la implementación de un sistema de calidad en instituciones de salud, le falta también hablar de las AESP y que nos de información de páginas relevantes para esta materia
By Luis Carlos Ríos Salazar on 5/20/2025
Tengo mucho contexto en relacion a temas de calidad... pero orientado a temas de salubridad es mi primer experiencia y fue fantástico
By Fernando Jorge Costa on 1/12/2025
Boa estrutura, muito boa apresentação e síntese. Muito útil para base de estrutura organizativa de planeamento em qualidade em saúde. Aconselho.
By Eszter Vorosne Baranyai on 1/8/2025
It was great. Scenarios or example for a mock inspection or quality assessment could be useful.
By Gregory Godfrey Mandari on 9/19/2024
As an ISO 9001:2015 lead auditor and a healthcare professional, this course is quite eye opening and couldn't have come at a better time. The instructor is meticulous.
By Paulo Eduardo de Andrade Souza on 9/10/2024
O curso está melhor do que eu esperava. principalmente nos comentários sobre a norma e sugestões de implementação.
By Janez Bencina on 7/26/2024
It is kind of refreshment for my Quality knowledge. I understand as the basis for ISO 7101 requirements.
Quality Score
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Overall Score : 90 / 100












