Self-Learning Course Structure for ISO 9001:2015 Quality Management System (QMS)

Module 1: Introduction to ISO 9001:2015

1. Overview of ISO 9001:2015
2. History and Evolution of ISO 9001
3. Key Changes in ISO 9001:2015
4. Benefits of ISO 9001 Certification
5. Structure of ISO 9001:2015 (Annex SL)

Module 2: 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

Module 3: PDCA (Plan-Do-Check-Act) Cycle

1. Introduction to PDCA
2. Plan: Setting objectives and planning processes
3. Do: Implementing and managing the processes
4. Check: Monitoring and measuring performance
5. Act: Taking corrective actions and improvements
6. PDCA Cycle and Its Role in ISO 9001:2015
7. Integrating PDCA into QMS
8. Tools and Techniques for PDCA Implementation
9. Benefits of PDCA
10. Challenges and Best Practices

Module 4: Clause 1: Scope

1. Purpose of the Standard
2. Applicability of ISO 9001:2015
3. Exclusions and Limitations

Module 5: Clause 2: Normative References

1. Understanding Normative References
2. Importance of Normative References in ISO 9001:2015

Module 6: Clause 3: Terms and Definitions

1. Key Definitions in ISO 9001:2015
2. Glossary of Relevant Terms

Module 7: Clause 4: Context of the Organization

1. Understanding the Organization and Its Context
2. Identifying Internal and External Issues
3. Understanding the Needs and Expectations of Interested Parties
4. Defining the Scope of the QMS
5. The PDCA Approach in Context

Module 8: Clause 5: Leadership and Commitment

1. Role of Top Management
2. Leadership Responsibilities
3. Quality Policy and Objectives
4. Organizational Roles and Responsibilities

Module 9: Clause 6: Planning for QMS

1. Actions to Address Risks and Opportunities
2. Quality Objectives and Planning to Achieve Them
3. Planning of Changes
4. The Role of PDCA in Planning

Module 10: Clause 7: Support Processes

1. Resources Needed for the QMS
2. Competence and Awareness of Employees
3. Communication Within the Organization
4. Documented Information (Records and Documentation)

Module 11: Clause 8: Operations – Delivering Quality

1. Operational Planning and Control
2. Requirements for Product and Service Delivery
3. Risk Management in Operations

Module 12: Clause 9: Evaluating Performance

1. Monitoring, Measurement, Analysis, and Evaluation
2. Internal Audits
3. Management Review

Module 13: Clause 10: Driving Improvement

1. Corrective Actions and Preventive Actions (CAPA)
2. Continuous Improvement Strategies
3. Nonconformity and Improvement

Module 14: Case Studies and Practical Applications

1. Real-life Examples of ISO 9001 Implementation
2. Industry-specific Use Cases (Manufacturing, Service, Healthcare)
3. Lessons Learned and Best Practices

Module 15: ISO 9001 Certification Process

1. Understanding the Certification Process
2. Stages of Certification
3. Preparing for Certification
4. Auditing and Documentation Requirements

Module 16: Mock Exercises and Sample Templates

1. Mock ISO 9001 Audits
2. Sample Quality Policy
3. Risk Matrix Templates
4. Action Plan Templates for Non-conformities
5. Corrective Action Requests (CAR) Templates

Module 17: Certification Opportunities and Career Growth

1. Internal Auditor Certification
2. Lead Auditor Certification
3. ISO 9001 Practitioner Certification
4. ISO 9001:2015 Certificate Offered by Accredited Certification Bodies
5. Standards and Guidelines

Appendix A: Glossary of Key Terms

1. Definitions of Key Terms Used in ISO 9001

Appendix B: Example Documentation Templates

1. Quality Policy Template
2. Risk Assessment Matrix Template
3. Process Flowcharts

Appendix C: Checklist for Internal Audits

1. Internal Audit Procedure
2. Checklist for Different ISO 9001 Clauses
3. Audit Report Templates

Appendix D: Reference Books and Resources

1. Books and Resources