ISO 7101:2023 Healthcare Quality Management Systems Foundation Level Training and Certification Program

Programme Summary

Build an understanding of healthcare quality management using ISO 7101:2023. Participants connect people centred care, patient safety and controlled service delivery with responsibilities and performance measures. Exercises based on a hospital and outpatient service case develop requirement interpretation, evidence selection and gap recognition. The programme establishes a foundation for consistent healthcare quality and accountable organisational improvement and further implementation or auditor development.

Training Objectives

1 Explain healthcare quality management requirements; 2 Connect requirements with operational responsibilities; 3 Recognise unmanaged care process risks; 4 Select relevant implementation evidence; 5 Prepare for further practical development.

Learning Outcomes

1 Map care process and governance interfaces; 2 Identify people centred service controls; 3 Prioritise organisational patient safety risks; 4 Evaluate healthcare quality and experience evidence; 5 Define measurable service improvement actions.

Target Audience

Healthcare Quality Directors; Patient Safety Managers; Hospital Operations Managers; Clinical Governance Managers; Management System Coordinators.

Target Industries

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

Course Contents

• Module 1 Standard Purpose and Practical Application: Management system purpose and intended outcomes; Requirement guidance and evidence distinctions; Course case scope and learning responsibilities.
• Module 2 Healthcare Context and Quality System Scope: Care services organisational boundaries and stakeholders; Patient workforce and community needs; Healthcare obligations and service quality objectives.
• Module 3 Leadership Quality Culture and Governance: Leadership accountability and quality policy; Clinical and non clinical governance interfaces; Responsibilities resources and organisational learning.
• Module 4 People Centred and Equitable Care: Respect dignity and patient participation; Accessible information and communication needs; Patient experience feedback and fair service access.
• Module 5 Healthcare Risk and Patient Safety: Care process risks and prevention controls; Patient and workforce safety interfaces; Incident reporting escalation and learning culture.
• Module 6 Controlled Healthcare Service Delivery: Process design continuity and handover controls; Competent people resources and supplier interfaces; Planned changes and service disruption arrangements.
• Module 7 Healthcare Information and Documented Evidence: Reliable service records and information access; Confidentiality privacy and controlled documentation; Data quality for clinical and nonclinical measures.
• Module 8 Measuring Healthcare Quality and Experience: Process outcome and experience indicators; Variation trend analysis and improvement priorities; Monitoring controls and meaningful patient feedback.
• Module 9 Healthcare Assurance and Improvement: Internal audit and management review; Corrective action and evidence of effectiveness; Sustaining improvement and accountable service learning.
• Module 10 Interpreting Requirements in Context: Mandatory requirements and proportionate application; Interfaces with applicable legal obligations; Supported judgements and unresolved interpretation issues.
• Module 11 Selecting Relevant Management System Evidence: Care process and handover records; Patient safety and experience reports; Service performance and improvement records.
• Module 12 Foundation Application Workshop: Map responsibilities within the supplied case; Match controls to relevant requirements; Explain gaps and practical next steps.

Assessment

• 60 single best answer questions, including applied scenarios; one mark per question.
• 90 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 (45 minutes): Using a supplied hospital and outpatient service case, produce a care service process map and quality priorities, link three controls to relevant requirements and explain one unresolved weakness.
• Assessment criteria: Accurate interpretation of healthcare quality management requirements; Relevant use of care process and handover records; Clear connection between controls responsibilities and identified gaps.
• Pass each component separately: 45/60 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 foundation knowledge of healthcare quality management; it does not establish professional auditor status, independent personnel certification or 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

333

Total teaching hoursTotal teaching hoursTotal teaching hours

18 hours; breaks, pre course work and formal final assessments excluded.18 hours; breaks, pre course work and formal final assessments excluded.18 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

No formal qualification required. Familiarity with healthcare quality management activities and everyday business processes is recommended.No formal qualification required. Familiarity with healthcare quality management activities and everyday business processes is recommended.No formal qualification required. Familiarity with healthcare quality management activities and everyday business processes is recommended.

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

Complete a 20-minute diagnostic and identify how care process and handover records support a supplied operational case.Complete a 20-minute diagnostic and identify how care process and handover records support a supplied operational case.Complete a 20-minute diagnostic and identify how care process and handover records support a supplied operational case.

End of course assessmentEnd of course assessmentEnd of course assessment

60 question written exam (90 minutes) and individual applied task (45 minutes).60 question written exam (90 minutes) and individual applied task (45 minutes).60 question written exam (90 minutes) and individual applied task (45 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.