ISO 7101 Healthcare Quality Lead Auditor

Plan and conduct audits of healthcare quality management, evaluate evidence and follow up findings on patient-centred processes, clinical risks and service improvement.

Work through patient-centred processes, clinical risks and service improvement and connect them to the responsibilities of your audit or assessment role. The detailed programme explains the methods and activities covered.

By the end of the course, participants will be able to:

• Understand the principles and requirements of ISO 7101:2023.
• Interpret and apply the requirements of ISO 7101 during audit activities.
• Plan and prepare for HQMS audits effectively, including developing audit programs and checklists.
• Conduct HQMS audits in accordance with ISO 7101 requirements, including gathering evidence, interviewing personnel, and documenting findings.
• Apply audit techniques and methodologies to identify nonconformities and areas for improvement.
• Prepare audit reports and communicate findings to relevant stakeholders.
• Understand the process for audit follow-up and verification of corrective actions.

• Healthcare Quality assurance managers and officers.
• Internal auditors responsible for auditing HQMS within organizations.
• Professionals seeking to become certified lead auditors for ISO 7101 audits.
• Personnel involved in implementing and maintaining HQMS within organizations.

• ISO 7101:2023 - Healthcare Quality Management systems - Requirements.
• They will understand how to apply ISO 19011:2018 and ISO 17011:2017 principles to ensure effective auditing, conformity assessment, and continual improvement within the Artificial Intelligence industry.

• Introduction to ISO 7101:2023
  • Overview of the standard
  • Key concepts and principles of Healthcare Quality Management
• Principles of Auditing According to ISO 19011
  • Fundamental concepts of auditing
  • Roles and responsibilities of auditors
  • Ethical considerations in auditing
• Audit Planning and Preparation according to ISO 17021:2015
  • Developing audit objectives and scope
  • Establishing audit criteria and methods
  • Creating audit programs and checklists
• Conducting Audits
  • Techniques for gathering evidence
  • Interviewing skills and communication techniques
  • On-site audit activities and observations
• Audit Reporting
  • Documentation of audit findings
  • Preparation of audit reports
  • Presentation of findings to management and stakeholders
• Audit Follow-up and Corrective Actions
  • Verification of corrective actions
  • Monitoring and measuring audit performance
  • Continuous improvement of the audit process
• Case Studies and Practical Exercises
  • Application of audit principles and techniques through hands-on exercises and real-world scenarios.

Duration: 5 days
Training Methodologies

• Case Study
• Individual Exercises
• Role Play
• Group Exercises
• Group Presentation
• Examination