Lesson 1Competence, training and awareness records: designing a minimal QMS training matrixThis part explains setting competence needs, making a simple effective QMS training matrix, planning and logging training, and ensuring staff know policies, steps, and their roles in quality and safety.
Defining competence for clinical and support rolesDesigning a minimal QMS training matrixPlanning induction and refresher trainingRecording attendance and competence evidenceEvaluating training effectiveness in practiceLesson 2Continuous improvement: CAPA process, PDSA cycles and small tests of changeThis part details setting up CAPA, using PDSA cycles, and running small change tests so hospitals handle incidents, check roots, fix actions, and build steady improvement into daily clinical practice.
Standard CAPA workflow for hospital eventsRoot cause analysis tools for clinical issuesDesigning and running PDSA cyclesSmall tests of change on pilot unitsMeasuring and sustaining improvementsLesson 3Performance monitoring: defining KPIs, internal audit program and management review inputsThis part covers setting useful KPIs, planning and doing internal audits, and prepping management review inputs so leaders check QMS performance, spot gaps, and rank fixes across hospital services.
Selecting hospital-wide and unit-level KPIsDesigning an annual internal audit programConducting risk-based clinical auditsPreparing data for management review meetingsTracking actions from reviews and auditsLesson 4Understanding ISO 9001 clauses relevant to healthcare (context, leadership, planning, support, operation, performance evaluation, improvement)This part puts key ISO 9001 clauses into hospital terms, showing how context, leadership, planning, support, ops, evaluation, and improvement fit clinical and non-clinical services.
Analyzing internal and external hospital contextLeadership roles and quality culture in hospitalsRisk-based quality planning for clinical servicesSupport processes for safe, reliable careOperational control of clinical and support servicesLesson 5Process mapping and standardization: critical clinical and non-clinical process flows (medication cycle, perioperative pathway, patient admission/discharge)This part guides mapping and standardizing key clinical and non-clinical processes like med handling, peri-op care, and patient in/out, to cut variation, clear roles, and back safe, smooth care.
Basics of process mapping in hospitalsMedication management end-to-end flowPerioperative pathway mapping and controlsAdmission, transfer and discharge workflowsStandardizing handoffs and documentationLesson 6Establishing scope, quality policy, quality objectives and key roles (Quality Coordinator responsibilities)This part explains defining QMS scope, writing a practical quality policy, setting measurable goals, and setting key roles, stressing the Quality Coordinator’s duties in running and keeping the system.
Defining hospital QMS scope and boundariesDrafting a clear, relevant quality policySetting SMART quality objectives for careAssigning QMS governance and committeesQuality Coordinator duties and authorityLesson 7Risk-based thinking and documented risk registers for clinical processesThis part shows embedding risk thinking into daily ops by spotting, rating, and logging clinical risks in neat registers, linking to controls, audits, KPIs, and fix priorities.
Identifying clinical and process risksRisk assessment scales and criteriaBuilding and maintaining risk registersLinking risks to controls and KPIsReviewing and updating risks routinelyLesson 8Documented information: creating mandatory procedures, work instructions and forms tailored to hospital needsThis part explains designing, writing, and managing lean compliant records like must-do procedures, work guides, and forms that match real hospital flows and back safe, steady patient care.
Identifying mandatory ISO 9001 documentsStructuring clear, usable hospital proceduresCreating concise clinical work instructionsDesigning simple, reliable hospital formsDocument control, versioning and access rulesLesson 9Operational controls and control of nonconforming services: incident handling and correctionThis part focuses on ops controls for clinical and support services and handling off-spec services, covering incident spotting, containing, fixing, logging, and linking to CAPA and risk work.
Defining operational controls for key processesDetecting and recording nonconforming careImmediate containment and safe correctionDocumentation and communication of incidentsInterface with CAPA and risk registersLesson 10Implementation timeline, responsibilities and simple outputs for each step (who, what, deliverable)This part gives a real ISO 9001 rollout plan for hospitals, setting phases, duties, and simple outputs per step so teams know who does what, when, and what to produce.
Phased ISO 9001 rollout plan for hospitalsRACI for key QMS implementation tasksDefining simple outputs for each project stepProgress tracking and status reporting toolsManaging resistance and change fatigue
