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

Programme Summary

Practise leading a structured healthcare quality management implementation project against ISO 7101:2023. Working through a hospital and outpatient service case, participants translate people centred care, patient safety and controlled service delivery into accountable controls, resources and measurable milestones. The programme develops an implementation portfolio, tests operational feasibility and prepares management review evidence to support consistent healthcare quality and accountable organisational improvement.

Training Objectives

1 Structure healthcare quality management implementation leadership; 2 Translate requirements into workable controls; 3 Coordinate ownership resources and project milestones; 4 Establish meaningful measures and review evidence; 5 Prepare implementation priorities for management approval.

Learning Outcomes

1 Build a healthcare quality management implementation roadmap; 2 Specify controls for unmanaged care process risks; 3 Design care process and handover records; 4 Assign accountable owners and measurable milestones; 5 Present a justified management review proposal.

Target Audience

Healthcare Quality Directors; Patient Safety Managers; Hospital Operations Managers; Implementation Project Managers; Management System Consultants.

Target Industries

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

Course Contents

• Module 1 Implementation Leadership and Project Mandate: Business case scope and intended benefits; Sponsor responsibilities and implementation team roles; Constraints resources and governance decisions.
• Module 2 Diagnostic Review and Implementation Priorities: Requirements mapping and baseline evidence; Risk based gaps and priority decisions; Implementation milestones and acceptance criteria.
• Module 3 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 Leadership Quality Culture and Governance: Leadership accountability and quality policy; Clinical and non clinical governance interfaces; Responsibilities resources and organisational learning.
• Module 5 People Centred and Equitable Care: Respect dignity and patient participation; Accessible information and communication needs; Patient experience feedback and fair service access.
• Module 6 Healthcare Risk and Patient Safety: Care process risks and prevention controls; Patient and workforce safety interfaces; Incident reporting escalation and learning culture.
• Module 7 Controlled Healthcare Service Delivery: Process design continuity and handover controls; Competent people resources and supplier interfaces; Planned changes and service disruption arrangements.
• Module 8 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 Measuring Healthcare Quality and Experience: Process outcome and experience indicators; Variation trend analysis and improvement priorities; Monitoring controls and meaningful patient feedback.
• Module 10 Healthcare Assurance and Improvement: Internal audit and management review; Corrective action and evidence of effectiveness; Sustaining improvement and accountable service learning.
• Module 11 Designing the Implementation Architecture: Process interactions and accountable control owners; Integration with existing management arrangements; Proportionate documentation and practical control design.
• Module 12 Operational Control Design Workshop: Preventing unmanaged care process risks; Addressing weak patient information protection; Responding to unresolved patient safety concerns.
• Module 13 Building the Required Evidence Portfolio: Care process and handover records; Patient safety and experience reports; Service performance and improvement records.
• Module 14 Competence Communication and Organisational Adoption: Role based competence and learning needs; Operational communication and stakeholder engagement; Resistance escalation and management support.
• Module 15 Resources Suppliers and Implementation Scheduling: Resource estimates and implementation dependencies; External support and supplier accountability; Controlled milestones and progress reporting.
• Module 16 Piloting Controls and Managing Changes: Pilot objectives and realistic acceptance checks; Operational feedback and control adjustments; Approval communication and controlled change records.
• Module 17 Monitoring Performance and Demonstrating Effectiveness: Measurable indicators and reliable data sources; Control performance and exception reporting; Evidence based decisions and corrective action.
• Module 18 Internal Assurance and Management Review: Internal audit planning and independence; Review inputs decisions and resource commitments; Readiness gaps and continuing improvement priorities.
• Module 19 Maintaining the Management System: Ownership handover and ongoing monitoring; Changing risks obligations and operating conditions; Learning mechanisms and improvement programme.
• Module 20 Implementation Portfolio and Leadership Simulation: Present controls responsibilities and milestones; Defend priorities using supplied evidence; Respond to management challenge and feedback.

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 (90 minutes): Using a hospital and outpatient service case, develop a healthcare quality implementation roadmap and governance control plan, assign resources and milestones, demonstrate one control and defend implementation priorities in a brief panel review.
• Assessment criteria: Workable design of controls for unmanaged care process risks; Relevant evidence portfolio including care process and handover records; Feasible sequencing ownership and measurable implementation acceptance criteria.
• 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 assessed implementation planning skills in healthcare quality management; it does not confer independent personnel certification or guarantee organisational certification.
• 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 20 delegates.Maximum 20 delegates.Maximum 20 delegates.

Training prerequisitesTraining prerequisitesTraining prerequisites

Working knowledge of ISO 7101:2023, relevant healthcare quality management experience and familiarity with project planning are required. Participants should understand process ownership and operational controls.Working knowledge of ISO 7101:2023, relevant healthcare quality management experience and familiarity with project planning are required. Participants should understand process ownership and operational controls.Working knowledge of ISO 7101:2023, relevant healthcare quality management experience and familiarity with project planning are required. Participants should understand process ownership and operational controls.

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

Complete a 45-minute gap diagnostic using supplied care process and handover records; identify priorities, process owners and implementation constraints.Complete a 45-minute gap diagnostic using supplied care process and handover records; identify priorities, process owners and implementation constraints.Complete a 45-minute gap diagnostic using supplied care process and handover records; identify priorities, process owners and implementation constraints.

End of course assessmentEnd of course assessmentEnd of course assessment

100 question written exam (150 minutes) and individual applied task (90 minutes).100 question written exam (150 minutes) and individual applied task (90 minutes).100 question written exam (150 minutes) and individual applied task (90 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.