Module 1: Introduction to Quality Management & ISO 9001

Purpose: Establish a strong foundation in quality management principles.
Key Topics:

Evolution of quality management

What ISO 9001 is (and what it is not)

Benefits of ISO 9001 for organizations

Overview of ISO standards and the Annex SL structure
Practical Exercise: Identifying quality challenges in participants’ organizations

Module 2: ISO 9001:2015 Structure & Clauses Overview

Purpose: Understand the standard clause by clause.
Key Topics:

High-Level Structure (HLS)

Clauses 4–10 explained

Mandatory vs non-mandatory requirements

Understanding “shall” statements
Workshop: Clause-to-process mapping

Module 3: Context of the Organization & Interested Parties

Purpose: Align the QMS with business reality.
Key Topics:

Internal and external context analysis

Identifying interested parties and their needs

Defining QMS scope correctly

Linking strategy to quality
Tool: SWOT & stakeholder analysis for QMS

Module 4: Leadership, Governance & Quality Culture

Purpose: Embed quality at leadership level.
Key Topics:

Leadership responsibilities in ISO 9001

Quality policy and objectives

Roles, responsibilities, and authorities

Building a quality-driven culture
Case Study: Leadership failure vs leadership-driven quality systems

Module 5: Process Approach & Risk-Based Thinking

Purpose: Turn ISO into operational systems.
Key Topics:

Process identification and interaction

Inputs, outputs, KPIs, and controls

Risk and opportunity assessment

Preventive thinking vs corrective thinking
Workshop: Process mapping & risk register development

Module 6: Support Processes & Documented Information

Purpose: Control systems without bureaucracy.
Key Topics:

Competence, awareness, and training

Communication requirements

Documented information control

Avoiding over-documentation traps
Exercise: Designing lean QMS documentation

Module 7: Operational Planning & Control

Purpose: Control quality where work happens.
Key Topics:

Operational controls and procedures

Managing changes

Supplier evaluation and control

Outsourced processes
Case Study: Supplier quality failure and corrective actions

Module 8: Performance Evaluation & Internal Audits

Purpose: Measure and verify QMS effectiveness.
Key Topics:

Monitoring and measurement

Key quality performance indicators

Internal audit planning and execution

Management review requirements
Simulation: Conducting an internal audit

Module 9: Nonconformities, Corrective Actions & Improvement

Purpose: Drive continual improvement.
Key Topics:

Handling nonconformities

Root cause analysis techniques

Corrective vs corrective action

Continual improvement tools
Workshop: Root cause analysis (5 Whys, Fishbone)

Module 10: Certification Readiness & Implementation Roadmap

Purpose: Prepare for certification success.
Key Topics:

Certification process explained

Common audit findings and mistakes

Pre-audit preparation

ISO 9001 implementation roadmap
Output: Action plan tailored to participants’ organizations