This RTI training provides a deep dive into the requirements of the ISO 9001:2015 standard. It is designed to help organizations transition from older versions or implement a brand-new QMS from scratch, focusing on Risk-Based Thinking and the Process Approach.

Who Should Attend?

• Quality Professionals: Quality Managers, QA/QC Inspectors, and Management Representatives.

• Leadership: Business owners and Senior Executives who need to understand their role in the “Leadership” clause.

• Department Heads: Managers responsible for operational processes (Production, HR, Sales, Procurement).

• Aspiring Auditors: Individuals looking to become internal or external QMS auditors.

2. Learning Objectives

By the end of this training, participants will be able to:

• Interpret the clauses of the ISO 9001:2015 standard in the context of their specific business.

• Apply the PDCA (Plan-Do-Check-Act) cycle to organizational processes.

• Identify and manage organizational risks and opportunities.

• Develop and maintain the necessary documented information (manuals, SOPs, records).

• Prepare for successful 3rd-party certification audits.

3. Training Methodology

To ensure maximum retention and practical application, the course utilizes a blended learning approach:

• Interactive Lectures: Instructor-led sessions focused on the “why” and “how” of the standard.

• Case Studies: Real-world scenarios where participants identify non-conformities and suggest corrective actions.

• Workshops: Hands-on exercises for drafting Quality Policies, Objectives, and Risk Registers.

• Quizzes & Roleplay: Knowledge checks and mock audit simulations to build confidence.

4. Course Outline

Module 1: Introduction to QMS & The High-Level Structure

• History and evolution of ISO 9001.

• The 7 Quality Management Principles.

• Understanding the Annex SL (High-Level Structure) is common to all new ISO standards.

Module 2: Context & Leadership (Clauses 4 & 5)

• Determining internal and external issues (SWOT/PESTLE analysis).

• Identifying “Interested Parties” and their requirements.

• Leadership commitment: Policy, roles, and responsibilities.

Module 3: Planning & Support (Clauses 6 & 7)

• Risk-Based Thinking: How to build a Risk Register.

• Setting SMART Quality Objectives.

• Resource management: People, infrastructure, and environment.

• Competence, awareness, and communication.

Module 4: Operation (Clause 8)

• Operational planning and control.

• Customer communication and requirements review.

• Design and development of products/services.

• Control of externally provided processes (Suppliers).

Module 5: Performance Evaluation & Improvement (Clauses 9 & 10)

• Monitoring, measurement, and analysis.

• Customer satisfaction surveys.

• The Internal Audit process.

• Management Review meetings.

• Non-conformity and corrective actions.

5. Summary Table of the ISO 9001:2015 Structure