𝗢𝘃𝗲𝗿𝘃𝗶𝗲𝘄
This comprehensive training package provides everything needed to deliver professional ISO 19011:2018 auditing training for ISO 9001:2015 Quality Management Systems. Designed by experienced IRCA auditors and quality management consultants, this module combines theoretical knowledge with practical application through real-world exercises and sector-specific examples.
𝗪𝗵𝗮𝘁'𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲𝗱
𝟭. 𝟱𝟱 𝗣𝗿𝗼𝗳𝗲𝘀𝘀𝗶𝗼𝗻𝗮𝗹 𝗧𝗿𝗮𝗶𝗻𝗶𝗻𝗴 𝗦𝗹𝗶𝗱𝗲𝘀
• Interactive HTML format (1280×720px, 16:9 aspect ratio)
• 100% PPTX/PDF export compatible
• Modern, elegant design with 40 unique layout templates
• NO gradients, shadows, or SVG icons (export-safe)
• Minimum 20px text for optimal projection
• Professional color palette: Navy #1F3A5F, Blue #3570F0, Green #27AE60, Red #C0392B
𝟮. 𝟳 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝗘𝘅𝗲𝗿𝗰𝗶𝘀𝗲𝘀 𝘄𝗶𝘁𝗵 𝗗𝗲𝘁𝗮𝗶𝗹𝗲𝗱 𝗔𝗻𝘀𝘄𝗲𝗿 𝗞𝗲𝘆𝘀
Exercise 1: Audit Principles Application (brother-in-law scenario)
Exercise 2: Design an Audit Programme (BioMedX GmbH medical devices)
Exercise 3: Writing Nonconformities (construction company)
Exercise 4: Draft Audit Report Section (AlphaLogistics Ltd)
Exercise 5: Auditor Selection (pharmaceutical audit)
Exercise 6: Full Audit Simulation (MediBuild GmbH, 2-day plan)
Exercise 7: Process Audit Simulation (AutoTech purchasing)
𝟯. 𝗙𝗶𝗻𝗮𝗹 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗣𝗮𝗰𝗸𝗮𝗴𝗲
30-question comprehensive exam (Word document)
Multiple choice, True/False, and scenario-based questions
Covers all modules (Clauses 1-7 + Annex A)
Passing score: 70% (21/30)
Detailed answer guide with clause references, rationale, and explanations
𝟰. 𝗦𝗲𝗰𝘁𝗼𝗿-𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰 𝗖𝗼𝗻𝘁𝗲𝗻𝘁
• Manufacturing: Production control, traceability, supplier management
• Healthcare: Competence, safety protocols, sterilization processes
• Construction: Subcontractor control, inspection test plans, site safety
• Service: SLA monitoring, knowledge management, customer satisfaction
• Training Module Structure
• Module 10: Introduction to ISO 19011 (3 slides)
What is ISO 19011? Purpose & 2018 Edition updates
Key definitions (Audit, Audit Programme, Audit Criteria, etc.)
Types of audits (1st, 2nd, 3rd party, combined/joint)
Module 11: The 7 Principles of Auditing (4 slides)
Principles 1-4: Integrity, Fair Presentation, Due Professional Care, Confidentiality
Principles 5-7: Independence, Evidence-based Approach, Risk-based Approach
Exercise 1: Identifying principles at risk in real scenarios
Module 12: Audit Programme Management – Clause 5 (8 slides)
What is an audit programme and its objectives
Managing risks and opportunities in the programme
Establishing, implementing, monitoring, and reviewing programmes
Audit methods (on-site, remote, observation, sampling)
Exercise 2: Design a 12-month audit programme for medical device manufacturer
Module 13: Conducting an Audit – Clause 6 (16 slides)
Complete audit process: Initiate → Prepare → Conduct → Report → Close → Follow-up
Initiating the audit (contact, feasibility, scope)
Preparing audit activities (document review, audit plan, work documents)
Opening meeting techniques
Collecting and verifying information (methods + audit trail diagram)
Audit findings classification (Conformity, Major NC, Minor NC, OFI)
Writing effective NC statements (Formula: Finding + Clause + Evidence)
Good vs weak NC statement comparison
Exercise 3: Writing NCs for construction company observations
Audit conclusions and closing meeting procedures
Audit report mandatory content (9 elements)
Exercise 4: Drafting audit report sections
Audit follow-up and corrective action verification
Module 14: Auditor Competence – Clause 7 (9 slides)
4-pillar competence framework (Personal Behavior, Generic Knowledge, Discipline-Specific, Programme Management)
Personal behavior and attributes (11 key traits)
Knowledge and skills requirements (audit methods, ISO 9001, sector, legal)
Evaluating auditor competence (5 methods)
Maintaining competence through CPD
Exercise 5: Auditor selection for pharmaceutical audit (3 candidates evaluation)
Exercise 6: Full audit simulation – MediBuild GmbH (2-day plan, opening questions, risk areas)
Module 15: Auditing ISO 9001 in Practice (10 slides)
Auditing Clause 4: Context of the Organization (issues, interested parties, scope, process approach)
Auditing Clauses 5 & 6: Leadership and Planning (commitment, policy, risks/opportunities, objectives)
Auditing Clause 7: Support (resources, competence, documented information, knowledge)
Auditing Clause 8: Operation (customer requirements, suppliers, production/service, nonconforming outputs)
Auditing Clauses 9 & 10: Performance Evaluation and Improvement (monitoring, internal audit, management review, corrective action)
Common audit traps and how to avoid them (4 warning strips)
Good audit practice checklist (pre-audit, during, closing, post-audit)
Sector focus areas (4 sectors with specific clause priorities)
Exercise 7: Process audit simulation – Purchasing department (3 NCs with root causes and corrective actions)
Module 16: Closing & Key Takeaways (4 slides)
ISO 19011 vs ISO 9001 relationship (How vs What)
6 key takeaways for effective auditing
Complete module summary table (Modules 10-16 mapped to clauses)
Training complete transition slide
Design Features
Modern Varied Layouts (40 Unique Templates)
Two-tone split layouts with navy accent panels
Numbered rows with large bold numbers (48px)
Horizontal process flows (4-step and 6-step)
Side-by-side contrast panels (red/green for risks/opportunities)
Audit trail diagrams with vertical flow visualization
KPI bars with CSS progress indicators
Horizontal timelines with numbered milestones
Formula bars with good/bad comparison layouts
Profile cards for candidate evaluation
Warning strips with color-coded alerts
4-column phase-based checklists
Comparison tables with statement bars
Day-plan tables with side-by-side info boxes
Status strips with colored left accents
Export Compatibility Guaranteed
NO gradients, NO box-shadow, NO backdrop-filter
NO SVG icons – Unicode symbols only (●, ▶, ✓, ✗, ★)
Strict overflow control (no scroll issues on export)
System fonts (Inter, Arial, Helvetica)
Solid colors and borders only
Tested for perfect PPTX/PDF conversion
Learning Outcomes
𝗕𝘆 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗶𝗻𝗴 𝘁𝗵𝗶𝘀 𝘁𝗿𝗮𝗶𝗻𝗶𝗻𝗴, 𝗽𝗮𝗿𝘁𝗶𝗰𝗶𝗽𝗮𝗻𝘁𝘀 𝘄𝗶𝗹𝗹 𝗯𝗲 𝗮𝗯𝗹𝗲 𝘁𝗼:
✓ Apply the 7 principles of auditing in real audit situations
✓ Plan and manage effective audit programmes (Clause 5)
✓ Conduct audits systematically from initiation to follow-up (Clause 6)
✓ Write clear, objective NC statements with proper evidence (Finding + Clause + Evidence formula)
✓ Evaluate auditor competence against ISO 19011 requirements (Clause 7: 4-pillar framework)
✓ Audit all ISO 9001:2015 clauses with confidence (Clauses 4-10)
✓ Identify red flags and avoid common audit traps
✓ Adapt auditing techniques to different industry sectors
Target Audience
Internal Auditors – Building or refreshing ISO 9001 audit skills
Lead Auditors – Training audit teams on ISO 19011 methodology
Quality Managers – Managing internal audit programmes
Certification Body Auditors – Professional development & CPD
Consultants – Delivering auditor training to clients
Operations Managers – Understanding the audit process as auditees
Training Providers – Ready-to-use training material for courses
Corporate Quality Departments – In-house auditor training
Technical Specifications
Format: Interactive HTML5 (1280×720px, 16:9 aspect ratio)
Compatibility: All modern browsers, PPTX export via platform
File Size: Optimized for fast loading (~15 MB complete package)
Fonts: Google Fonts (Inter) + system fallbacks (Arial, Helvetica)
Language: English
Accessibility: High-contrast design, readable fonts (20px minimum body text)
Delivery: Instant digital download (HTML package + Word documents)
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Source: Best Practices in ISO 9001, ISO 19011 PowerPoint Slides: ISO 19011:2018 Auditing ISO 9001 QMS PowerPoint (PPTX) Presentation Slide Deck, Smail Imzourh
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