ISO 9001:2015 standard requirements

Course Outline & Duration

Total Recommended Duration:

• Day 1 – Introduction & Quality Management Framework

Duration: 6–7 Hours

1. Course Introduction

Duration: 30 minutes

Topics:

• Course objectives and agenda
• Introduction to quality management systems
• Benefits of implementing ISO 9001
• Overview of certification process

2. Overview of the Standard

Duration: 45 minutes

Topics:

• Structure of ISO management system standards (Annex SL)
• Key terms and definitions
• The Quality Management Principles
• Process approach and risk-based thinking
• Plan–Do–Check–Act (PDCA) model

3. Clause 4 – Context of the Organization

Duration: 1 hour

Topics:

• Understanding the organization and its context
• Identifying interested parties
• Determining the scope of the QMS
• Establishing and documenting the quality management system

4. Clause 5 – Leadership

Duration: 1 hour

Topics:

• Leadership and commitment
• Customer focus
• Quality policy
• Organizational roles, responsibilities, and authorities

5. Clause 6 – Planning

Duration: 1.5 hours

Topics:

• Actions to address risks and opportunities
• Quality objectives and planning
• Planning changes in the QMS

6. Workshop / Exercise

Duration: 1 hour

Activities:

• Identifying interested parties
• Risk and opportunity identification
• Developing quality objectives

Day 2 – QMS Implementation & Improvement

Duration: 6–7 Hours

7. Clause 7 – Support

Duration: 1 hour

Topics:

• Resources
• Competence and training
• Awareness
• Communication
• Documented information

8. Clause 8 – Operation

Duration: 2 hours

Topics:

• Operational planning and control
• Customer requirements and communication
• Design and development (if applicable)
• Control of externally provided processes, products, and services
• Production and service provision
• Control of nonconforming outputs

9. Clause 9 – Performance Evaluation

Duration: 1.5 hours

Topics:

• Monitoring and measurement
• Customer satisfaction
• Internal audit
• Management review

10. Clause 10 – Improvement

Duration: 1 hour

Topics:

• Nonconformity and corrective action
• Continual improvement
• Improvement tools and techniques

11. Implementation Roadmap

Duration: 30–45 minutes

Topics:

• Steps to implement ISO 9001
• Required documentation and records
• Preparing for certification audit

12. Final Exercise / Case Study

Duration: 45 minutes

Activities:

• QMS implementation scenario
• Group discussion and review