1. Introduction to Quality Management Systems

1.1 Quality Management Fundamentals

• Quality management evolution including (inspection era, quality control, quality assurance, total quality management)

• ISO 9001 family of standards including (ISO 9000 vocabulary, ISO 9001 requirements, ISO 9004 performance improvement)

• Benefits of ISO 9001 implementation including (customer satisfaction, process efficiency, competitive advantage, market access)

• Quality Management System (QMS) structure including (documentation hierarchy, process interaction, system integration)

• Certification process overview including (implementation phases, certification body selection, surveillance audits)

1.2 ISO 9001:2015 Structure and Requirements

• High-Level Structure (HLS) including (Annex SL framework, common terminology, management system integration)

• Context of the organization including (understanding organizational context, interested parties, QMS scope determination)

• Leadership and commitment including (top management responsibilities, quality policy, organizational roles)

• Risk-based thinking including (opportunities and risks, preventive action integration, planning approaches)

• Performance evaluation including (monitoring and measurement, analysis, management review)

2. ISO 9001:2015 Detailed Requirements

2.1 Planning and Support Requirements

• Quality objectives setting including (SMART criteria, alignment with policy, measurable targets)

• Resource management including (competence determination, infrastructure provision, monitoring equipment)

• Documented information control including (creation requirements, update procedures, access control, retention)

• Communication planning including (internal communication, external communication, stakeholder engagement)

• Operational planning and control including (process criteria, change management, outsourced processes)

2.2 Operational and Improvement Requirements

• Product and service requirements including (customer communication, design and development, production control)

• Release of products and services including (conformity verification, acceptance criteria, traceability)

• Control of nonconforming outputs including (identification, containment, disposition, correction)

• Improvement processes including (continual improvement, nonconformity management, corrective action)

• Customer satisfaction monitoring including (feedback collection, complaint handling, satisfaction measurement)

3. Introduction to Auditing

3.1 Auditing Fundamentals

• Audit definition and purpose including (conformity assessment, effectiveness evaluation, improvement identification)

• Audit types including (first-party internal audits, second-party supplier audits, third-party certification audits)

• ISO 19011:2018 principles including (integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach, risk-based approach)

• Audit criteria and evidence including (audit standards, objective evidence, sampling techniques)

• Roles and responsibilities including (audit client, lead auditor, auditee, audit team members)

3.2 Auditor Competencies and Conduct

• Auditor competence requirements including (personal attributes, knowledge, skills, education, work experience)

• Professional behavior including (ethical conduct, objectivity, impartiality, confidentiality)

• Communication skills including (active listening, questioning techniques, interview methods, report writing)

• Conflict management including (handling resistance, managing disagreements, escalation procedures)

• Continuous professional development including (training requirements, experience maintenance, knowledge updating)

4. Audit Program Management

4.1 Audit Program Planning

• Audit program objectives including (compliance verification, system effectiveness, improvement opportunities)

• Audit program scope including (organizational coverage, process inclusion, frequency determination)

• Resource allocation including (auditor competence, time requirements, budget considerations)

• Audit scheduling including (annual planning, process coverage, risk-based prioritization)

• Program monitoring including (performance indicators, effectiveness measures, program review)

4.2 Risk-Based Audit Planning

• Risk assessment for audit planning including (process criticality, past performance, change impact)

• Audit frequency determination including (mandatory requirements, risk levels, resource availability)

• Audit scope adjustment including (focused audits, comprehensive audits, follow-up audits)

• Stakeholder consultation including (management input, process owner engagement, resource coordination)

• Program documentation including (audit schedules, resource plans, approval processes)

5. Individual Audit Planning and Preparation

5.1 Audit Planning

• Audit objectives definition including (specific focus areas, scope boundaries, expected outcomes)

• Audit team selection including (competence matching, independence verification, team composition)

• Document review including (procedures, work instructions, previous audit reports, performance data)

• Audit plan development including (audit schedule, process sequence, time allocation, logistics)

• Checklist preparation including (requirement-based questions, process-specific inquiries, sampling criteria)

5.2 Audit Preparation Activities

• Background research including (organizational context, process understanding, regulatory requirements)

• Opening meeting preparation including (agenda development, attendee identification, presentation materials)

• Audit trail planning including (process flow, document linkages, sampling strategies)

• Communication with auditees including (notification, schedule confirmation, information requests)

• Team briefing including (role assignments, approach alignment, coordination procedures)

6. Conducting the Audit

6.1 Opening Meeting and Initial Activities

• Opening meeting conduct including (introductions, audit objectives, scope confirmation, schedule review)

• Audit methodology explanation including (sampling approach, evidence collection, confidentiality assurance)

• Roles and responsibilities clarification including (guide assignment, access arrangements, communication protocols)

• Questions and concerns addressing including (auditee clarifications, logistical arrangements, special requests)

• Audit trail confirmation including (starting point, process sequence, facility access)

6.2 Information Gathering and Evidence Collection

• Interviewing techniques including (open-ended questions, probing questions, follow-up inquiries, neutral language)

• Document examination including (procedure review, record verification, document control assessment)

• Observation methods including (process witnessing, activity monitoring, practice verification)

• Evidence evaluation including (sufficiency, reliability, relevance, verifiability)

• Sampling strategies including (random sampling, representative sampling, statistical methods, judgment sampling)

7. Process-Based Auditing

7.1 Understanding Process Approach

• Process identification including (core processes, support processes, management processes)

• Process interaction including (input-output relationships, interfaces, interdependencies)

• Process performance including (monitoring methods, measurement criteria, targets)

• Process ownership including (responsibilities, authorities, accountability)

• Turtle diagram methodology including (inputs, outputs, resources, methods, measures, risks)

7.2 Auditing Processes Effectively

• Process entry and exit criteria including (starting points, completion verification, handoffs)

• Following the process flow including (sequential verification, parallel activities, decision points)

• Effectiveness assessment including (objective achievement, customer satisfaction, performance trends)

• Efficiency evaluation including (resource utilization, waste identification, cycle time)

• Risk and opportunity identification including (potential failures, improvement areas, best practices)

8. Audit Findings and Nonconformities

8.1 Identifying Nonconformities

• Nonconformity definition including (requirement deviation, system breakdown, process failure)

• Nonconformity classification including (major nonconformity, minor nonconformity, observations, opportunities for improvement)

• Evidence-based determination including (objective facts, requirement traceability, verification)

• Root cause consideration including (systemic issues, isolated incidents, recurring patterns)

• Documenting findings including (clear statements, specific references, factual description)

8.2 Positive Findings and Opportunities

• Conformity recognition including (effective practices, good controls, positive results)

• Best practice identification including (innovative approaches, superior performance, benchmark examples)

• Improvement opportunities including (efficiency enhancements, risk reduction, capability development)

• Balanced reporting including (strengths and weaknesses, context consideration, constructive feedback)

• Value-added auditing including (business insight, strategic alignment, competitive advantage)

9. Audit Reporting and Follow-up

9.1 Closing Meeting and Immediate Reporting

• Closing meeting preparation including (findings summary, evidence review, team consensus)

• Closing meeting conduct including (findings presentation, classification explanation, auditee response)

• Audit conclusions including (overall conformity, system effectiveness, improvement trends)

• Corrective action discussion including (timeframe expectations, responsibility assignment, verification planning)

• Acknowledgment and appreciation including (cooperation recognition, commitment confirmation, next steps)

9.2 Audit Report Development

• Report structure including (executive summary, scope and objectives, methodology, detailed findings)

• Findings description including (nonconformity statements, evidence references, requirement citations)

• Report clarity including (objective language, specific details, unambiguous statements)

• Distribution and communication including (stakeholder notification, confidentiality maintenance, access control)

• Report retention including (record keeping, retrieval systems, archiving procedures)

10. Corrective Action and Verification

10.1 Corrective Action Process

• Immediate correction including (problem containment, temporary fixes, symptom addressing)

• Root cause analysis including (Five Whys, Fishbone Diagram, Fault Tree Analysis, Is/Is Not Analysis)

• Corrective action planning including (permanent solutions, preventive measures, implementation schedules)

• Resource allocation including (personnel, budget, time, equipment)

• Effectiveness criteria including (problem elimination, recurrence prevention, performance improvement)

10.2 Follow-up Auditing

• Verification planning including (timing determination, scope definition, evidence requirements)

• Corrective action review including (implementation verification, documentation assessment, completion confirmation)

• Effectiveness evaluation including (performance monitoring, trend analysis, sustainability assessment)

• Closure criteria including (satisfactory evidence, requirement compliance, management acceptance)

• Follow-up reporting including (verification results, outstanding issues, recommendations)

11. Advanced Auditing Techniques

11.1 Integrated Management System Auditing

• IMS concept including (ISO 9001, ISO 14001, ISO 45001 integration, common requirements)

• Combined audit approach including (unified planning, simultaneous assessment, consolidated reporting)

• Synergy identification including (shared processes, common documentation, integrated objectives)

• Efficiency gains including (reduced audit time, resource optimization, stakeholder convenience)

• Cross-functional assessment including (multiple perspectives, holistic evaluation, system interaction)

11.2 Remote and Digital Auditing

• Remote audit technologies including (video conferencing, screen sharing, document repositories, digital workflows)

• Remote audit planning including (technology testing, security arrangements, participant coordination)

• Virtual evidence collection including (electronic records, real-time observation, recorded demonstrations)

• Remote audit challenges including (communication limitations, trust building, technical difficulties)

• Hybrid audit approaches including (combining on-site and remote activities, phased execution, flexible adaptation)

12. Case Studies & Group Discussions

• Regional audit scenarios including (manufacturing processes, service delivery, project management, support functions)

• The importance of proper training in developing competent internal auditors and maintaining effective quality management systems