Instructor

Cognicert ISO 7101 Healthcare Quality Lead Auditor Course | Master Healthcare Auditing

Curriculum

Learn to audit healthcare quality management systems with the Cognicert ISO 7101 Healthcare Quality Lead Auditor course. Ensure compliance and improve healthcare service quality.

Ratings

( 4.5 Ratings )

Live Online Classes starting on 01 January, 1970

Cognicert - ISO 7101 Healthcare Quality Lead Auditor Course

ISO 7101 Healthcare Quality Management System Lead Auditor Course provides participants with the knowledge and skills necessary to lead audits of quality management systems within healthcare organizations. This comprehensive training program covers the principles, processes, and practices of auditing healthcare quality management systems, focusing on key standards and regulations applicable to the healthcare industry.

 

Target Audience:

  • 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.

 

Reference Standards:

  •  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.

Objectives:

  • 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.

Training Methodologies

  •  Case Study

  •  Individual Exercises

  •  Role Play

  •  Group Exercises

  •  Group Presentation

  •  Examination

 

Course Outline

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

(4.5 Ratings)

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