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Course Details

ISO 7101:2023 Healthcare Quality Management System Requirements Training Course

Course Area

Medical Devices

Course Duration

2 Days

Continuing Education Units


Course Fee

USD $1620.00

Early Bird Price*

USD $1520.00

Upcoming Sessions
Nov 4-5, 2024 - Live Online - Full DayEnroll

View all sessions

* Subject to availability

Course Details

Course description:

ISO 7101:2023 is the inaugural global standard for healthcare quality management. It guides organizations, irrespective of size or structure, in establishing sustainable, high-quality health systems. Emphasizing a people centred approach and risk identification, it ensures patient and workforce safety, controlled service delivery, and continuous improvement. Implementation leads to refined healthcare quality, improved patient safety, cost-efficiency, operational effectiveness, and enhanced reputation with expanded market reach.

This course is designed to provide participants with a comprehensive understanding of the requirements for healthcare quality management systems. The course covers the key principles of ISO 7101:2023, including the creation of a culture of quality, people centred care, risk identification and management, patient and workforce safety, and continual improvement. Participants will learn how to apply these principles in their healthcare organizations to improve the quality of healthcare delivery and care outcomes. The course is suitable for healthcare professionals, quality managers, and anyone interested in healthcare quality management.

Course Aim:

This course aims to provide participants with insights into the purpose and requirements of a healthcare quality management system. Through a systematic framework, it encourages the creation of a culture of quality, effective risk identification and resolution, and the adoption of a people-centred health system founded on values such as respect, compassion, co-production, fairness, and dignity.

How will I benefit?

This course will help you to:

  • Gain an understanding of the purpose and requirements of healthcare quality management systems under ISO standards
  • Familiarize yourself with the implementation framework based on ISO 7101:2023, and develop the ability to tailor it to your specific situation
  • Enhance interactions and communication within medical care processes, acquire skills for operating a structured Management System, and recognize how quality in healthcare contributes to Sustainable Development Goals.

What will I learn?

By the end of the course you’ll be able to:

  • Acquire knowledge of ISO 7101:2023 terminology, concepts, and fundamentals
  • Understand the purpose and applicability of ISO 7101:2023 in healthcare organizations
  • Interpret the requirements and intent of the ISO 7101:2023 standard
  • Recognize the relationship between stakeholder needs and expectations in healthcare processes
  • Apply risk management principles in healthcare processes
  • Understand and apply concepts of people-centred care

Who should attend?

The course is especially suitable for: All staff working in the healthcare industry

Course Duration

2 days

How will I learn?

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.


A basic understanding of quality management systems would be useful, not mandatory.

Related Training

ISO 13485, ISO 9001, ISO 14001, ISO 7101 and other QMS training courses.

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

  • Students need to connect to the class from any internet accessible location.
  • Webcam and Microphone are REQUIRED.
  • ALL course times shown are US EASTERN TIME.

If your class is In-person :

  • You are encouraged to bring a laptop with you to class.
  • Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.

All Upcoming Course Dates

Date and Time Location Fees Enroll
Nov 4, 2024 9:00 AM - 5:30 PM ET
Nov 5, 2024 9:00 AM - 5:30 PM ET
Live Online - Full DayUSD $1620.00Enroll

The venues for scheduled courses are tentative until receipt of a course confirmation from BSI.

Live Online Classes

Certified, convenient, and interactive, with no travel costs.

Private Class

Interested in a private or customized version of this course? Request a quote.


For questions regarding any of our courses, contact us or call 1.800.217.1390.


For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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