Module 1: Introduction to ISO 9001:2015 (45–60 min)

• What is ISO and the purpose of ISO 9001
• Evolution to the 2015 version; compatibility with Annex SL
• Benefits of a QMS: customer satisfaction, consistency, risk reduction, efficiency
• Key terms: QMS, context, interested parties, risk, nonconformity, corrective action, competence
• Seven Quality Management Principles:
  1. Customer focus
  2. Leadership
  3. Engagement of people
  4. Process approach
  5. Improvement
  6. Evidence-based decision making
  7. Relationship management
• Exercise: Identify quality objectives aligned to your business goals

Deliverables:

• Quick reference guide to QMS terms

Module 2: High-Level Structure and Process Approach (45 min)

• Annex SL structure: Clauses 1–10 overview
• PDCA cycle and how ISO 9001 aligns with Plan–Do–Check–Act
• The process approach: defining inputs, outputs, owners, KPIs, and interactions
• Risk-based thinking: identifying risks/opportunities in processes
• Exercise: Map a core process and define KPIs

Deliverables:

• Process map template
• Risk/opportunity register template

Module 3: Clause-by-Clause Deep Dive (3–3.5 hours)

• Clause 4: Context of the organization
  • Internal/external issues; needs/expectations of interested parties
  • Determining QMS scope; QMS processes and interactions
  • Activity: Context and stakeholder analysis
• Clause 5: Leadership
  • Quality policy, roles, responsibilities, and organizational alignment
  • Activity: Drafting or reviewing a quality policy
• Clause 6: Planning
  • Addressing risks and opportunities; quality objectives and planning changes
  • Activity: Writing SMART quality objectives and plans
• Clause 7: Support
  • Resources, competence, awareness, communication, documented information
  • Documentation: what’s required vs. what’s useful; control of documents/records
  • Activity: Define competence matrix and document control
• Clause 8: Operation
  • Operational planning and control; requirements for products/services
  • Design and development (when applicable)
  • Control of externally provided processes/products/services (supplier control)
  • Production/service provision; release; nonconforming outputs
  • Activity: Build a simple control plan for a key process
• Clause 9: Performance Evaluation
  • Monitoring and measurement, analysis and evaluation
  • Internal audits: planning, conducting, reporting
  • Management review: inputs, outputs, records
  • Activity: Draft an internal audit plan and checklist
• Clause 10: Improvement
  • Nonconformity and corrective action; continual improvement mechanisms
  • Root cause analysis tools (5 Whys, Fishbone)
  • Activity: Complete a corrective action form with root cause

Deliverables:

• Clause quick sheets
• Documented information matrix (which docs/records to keep)

Module 4: Building and Implementing Your QMS (60–75 min)

• Gap assessment against ISO 9001:2015 requirements
• QMS implementation roadmap and project plan
• Aligning processes, KPIs, and objectives; change management and culture
• Integrating QMS with existing systems (e.g., ISO 14001, ISO 45001)
• Activity: Draft a phased implementation plan with milestones

Deliverables:

• Gap analysis checklist (editable)
• QMS implementation project plan template

Module 5: Internal Auditing Essentials (60 min)

• Audit terms and ethics; auditor competence and independence
• Audit planning, sampling, and objective evidence
• Conducting interviews, tracing process flows, and documenting findings
• Writing clear nonconformity statements; grading findings
• Activity: Role-play audit scenario and write a finding

Deliverables:

• Internal audit plan and schedule template
• Audit checklist examples (process-based)

Module 6: Certification Journey and Maintaining Compliance (30–45 min)

• Selecting a certification body; Stage 1 vs. Stage 2 audits
• Handling audit findings and corrective actions
• Post-certification surveillance audits and continual improvement cycle
• KPIs dashboarding and management reviews cadence
• Activity: Prepare a certification readiness pack

Deliverables:

• Certification readiness checklist
• Management review agenda/template

Capstone Assessment (30–45 min)

• Case study: Assess a fictional company’s QMS
• Tasks: Identify gaps, propose corrective actions, prioritize improvements
• Final quiz: 30–40 questions covering all clauses and key concepts

Certification:

• Pass mark: 70% on final quiz + completion of activities
• Issued: Certificate of Completion (PDF)

Target Audience

• Quality Managers, Process Owners, Operations Managers
• Internal Auditors and Compliance Officers
• SMEs and startups implementing their first QMS
• Teams preparing for ISO 9001 certification or recertification

Learning Materials Included

• Slide decks (per module)
• Templates: policy, objectives, process map, R&O register, audit checklist, NC/CAPA form, management review, gap checklist, project plan
• Case studies and sample documented procedures