ISO 7101:2023 Healthcare Quality Management Systems Lead Auditor Training and Certification Program

Programme Summary

Develop the planning, evidence evaluation and team leadership skills needed for healthcare quality management audits against ISO 7101:2023. A hospital and outpatient service case connects people centred care, patient safety and controlled service delivery with realistic audit trails. Participants lead simulated meetings, evaluate conflicting evidence and defend findings, producing a clear audit conclusion while respecting impartiality, confidentiality and the limits of sampled evidence.

Training Objectives

1 Strengthen healthcare quality management audit leadership; 2 Plan defensible assignments and team responsibilities; 3 Evaluate conformity and system effectiveness; 4 Manage findings communication and audit conclusions; 5 Maintain ethical conduct and audit independence.

Learning Outcomes

1 Lead a simulated healthcare quality management audit; 2 Evaluate patient safety and experience reports; 3 Direct risk based sampling and interviews; 4 Defend findings and evidence limitations; 5 Recommend proportionate corrective action follow up.

Target Audience

Audit Team Leaders; Management System Auditors; Healthcare Quality Directors; Patient Safety Managers; Assurance Managers.

Target Industries

Hospitals; Outpatient Clinics; Primary Care Networks; Specialist Healthcare Centres; Community Healthcare Providers.

Course Contents

• Module 1 Audit Leadership and Professional Boundaries: Audit principles impartiality and confidential information; First second and third party distinctions; Auditor competence and certification decision boundaries.
• Module 2 Audit Programme and Assignment Risk: Programme objectives and changing operational risks; Scope criteria resources and team competence; Remote methods feasibility and evidence security.
• Module 3 Auditing Healthcare Context and Quality System Scope: Care services organisational boundaries and stakeholders; Patient workforce and community needs; Healthcare obligations and service quality objectives.
• Module 4 Auditing Leadership Quality Culture and Governance: Leadership accountability and quality policy; Clinical and non clinical governance interfaces; Responsibilities resources and organisational learning.
• Module 5 Auditing People Centred and Equitable Care: Respect dignity and patient participation; Accessible information and communication needs; Patient experience feedback and fair service access.
• Module 6 Auditing Healthcare Risk and Patient Safety: Care process risks and prevention controls; Patient and workforce safety interfaces; Incident reporting escalation and learning culture.
• Module 7 Auditing Controlled Healthcare Service Delivery: Process design continuity and handover controls; Competent people resources and supplier interfaces; Planned changes and service disruption arrangements.
• Module 8 Auditing Healthcare Information and Documented Evidence: Reliable service records and information access; Confidentiality privacy and controlled documentation; Data quality for clinical and nonclinical measures.
• Module 9 Auditing Measuring Healthcare Quality and Experience: Process outcome and experience indicators; Variation trend analysis and improvement priorities; Monitoring controls and meaningful patient feedback.
• Module 10 Auditing Healthcare Assurance and Improvement: Internal audit and management review; Corrective action and evidence of effectiveness; Sustaining improvement and accountable service learning.
• Module 11 Document Review and Readiness Evaluation: Scope documents and process evidence review; Readiness concerns and additional information requests; Audit plan adjustments and communication.
• Module 12 Planning Activities and Directing the Team: Responsibilities schedules and audit trail allocation; Sampling strategy and technical expert interfaces; Team briefings progress checks and coordination.
• Module 13 Opening Meetings and Audit Communication: Confirming scope criteria and practical arrangements; Managing professional disagreement and access issues; Communicating emerging risks and material concerns.
• Module 14 Gathering and Corroborating Audit Evidence: Care process and handover records; Patient safety and experience reports; Service performance and improvement records.
• Module 15 Evidence Judgement and Escalation: Evidence of unmanaged care process risks; Evidence of weak patient information protection; Sampling limitations and additional evidence decisions.
• Module 16 Developing Findings and Audit Conclusions: Linking criteria evidence and supported findings; Evaluating systemic patterns and management effectiveness; Conclusions within scope and evidence limitations.
• Module 17 Reporting and Closing the Audit: Balanced report structure and clear findings; Closing meeting leadership and disagreement records; Confidential distribution and controlled audit records.
• Module 18 Corrective Action Review and Follow Up: Assessing cause analysis and proposed action; Verifying implementation and effectiveness evidence; Follow up escalation and unresolved findings.
• Module 19 Audit Quality and Professional Development: Reviewing audit performance and consistency; Technical competence and experience development; Learning feedback and ongoing ethical conduct.
• Module 20 Lead Audit Team Simulation: Lead assigned meetings and team briefings; Evaluate conflicting evidence and defend findings; Present conclusions and follow up recommendations.

Assessment

• 100 single best answer questions, including applied scenarios; one mark per question.
• 150 minute invigilated digital examination with identity verification. Approved accessibility adjustments preserve the assessed competence.
• Clean standard text and supplied case documents permitted; internet, messaging and external AI tools prohibited.
• Individual applied assessment (150 minutes): Lead a simulated healthcare quality management audit, assign team activities, conduct an assessed interview, evaluate conflicting records, present supported findings and defend the audit conclusion and follow up decisions.
• Assessment criteria: Defensible audit scope and sampling of patient safety and experience reports; Effective team direction interviewing and closing meeting leadership; Evidence linked findings conclusions and justified follow up decisions.
• Pass each component separately: 75/100 written marks (75%) and at least 70% on the applied task.
• All mandatory criteria must pass: Do not fabricate evidence or knowingly present unsupported conformity conclusions; Protect confidential or personal information within supplied case material.
• Individual results and feedback are provided. One reassessment may follow coaching under the published enrolment terms.

Certification

• Successful learners receive a TQCSI Arabia digital Certificate of Successful Completion.
• The certificate records the learner name, exact programme title, teaching hours, completion date and unique verification reference.
• Verified identity, full attendance and separate written and applied passes are required; all mandatory critical criteria must be met.
• Proposed issue target: within 30 calendar days of approved results and settlement of applicable fees.
• Records successful lead auditor training in healthcare quality management; auditor registration, certification body appointment and independent personnel certification require separate evaluation.
• Attendance confirmation may record completed hours for unsuccessful learners; it does not certify successful completion.

Programme Profile

Number of daysNumber of daysNumber of days

555

Total teaching hoursTotal teaching hoursTotal teaching hours

35 hours; breaks, pre course work and formal final assessments excluded.35 hours; breaks, pre course work and formal final assessments excluded.35 hours; breaks, pre course work and formal final assessments excluded.

Delegates allowedDelegates allowedDelegates allowed

Maximum 16 delegates.Maximum 16 delegates.Maximum 16 delegates.

Training prerequisitesTraining prerequisitesTraining prerequisites

Working knowledge of ISO 7101:2023, audit fundamentals and relevant healthcare quality management experience is required. Prior internal audit practice is strongly recommended.Working knowledge of ISO 7101:2023, audit fundamentals and relevant healthcare quality management experience is required. Prior internal audit practice is strongly recommended.Working knowledge of ISO 7101:2023, audit fundamentals and relevant healthcare quality management experience is required. Prior internal audit practice is strongly recommended.

Pre course assignment and assessmentPre course assignment and assessmentPre course assignment and assessment

Complete a 45-minute requirements and audit diagnostic; review patient safety and experience reports and identify high risk audit trails.Complete a 45-minute requirements and audit diagnostic; review patient safety and experience reports and identify high risk audit trails.Complete a 45-minute requirements and audit diagnostic; review patient safety and experience reports and identify high risk audit trails.

End of course assessmentEnd of course assessmentEnd of course assessment

100 question written exam (150 minutes) and individual applied task (150 minutes).100 question written exam (150 minutes) and individual applied task (150 minutes).100 question written exam (150 minutes) and individual applied task (150 minutes).

Passing criteriaPassing criteriaPassing criteria

75% written and 70% applied, passed separately; full attendance. All mandatory criteria must pass.75% written and 70% applied, passed separately; full attendance. All mandatory criteria must pass.75% written and 70% applied, passed separately; full attendance. All mandatory criteria must pass.