ISO 9001: Quality Management Systems

 

Course Objectives

1. To provide an in-depth understanding of ISO 9001:2015 standards and requirements.
2. To equip participants with the skills to develop, implement, and maintain a Quality Management System (QMS).
3. To foster the ability to conduct internal audits and identify non-conformities.
4. To enhance participants' understanding of continual improvement within a QMS.

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Learning Outcomes

By the end of the course, participants will be able to:

1. Interpret the principles, clauses, and requirements of ISO 9001:2015.
2. Develop and document a QMS aligned with ISO 9001 standards.
3. Conduct effective internal audits, including planning, execution, and reporting.
4. Identify risks and opportunities for improvement within a QMS framework.
5. Lead or support an organization in achieving ISO 9001 certification.

 

Day 1: Foundations and QMS Requirements

8:30 AM – 9:00 AM

• Registration and Welcome Session
• Introduction of Trainer(s) and Participants

9:00 AM – 10:30 AM

Module 1: Introduction to ISO 9001

• Overview of ISO 9001:2015
• Importance of Quality Management Systems (QMS)
• Structure and Key Principles of ISO 9001

10:30 AM – 10:45 AM

• Coffee/Tea Break

10:45 AM – 12:30 PM

Module 2: Understanding ISO 9001 Requirements (Part 1)

• Context of the Organization
• Leadership and Commitment
• Risk-Based Thinking and Strategic Planning

12:30 PM – 1:30 PM

• Lunch Break

1:30 PM – 3:00 PM

Module 2: Understanding ISO 9001 Requirements (Part 2)

• Support Processes: Competence, Awareness, and Communication
• Operational Planning and Control

3:00 PM – 3:15 PM

• Coffee/Tea Break

3:15 PM – 5:00 PM

Workshop: Applying ISO 9001 Requirements

• Group Exercise: Identifying Organizational Context and Scope
• Discussion: Leadership Roles and Responsibilities

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Day 2: Implementation, Audits, and Certification

8:30 AM – 9:00 AM

• Recap of Day 1 and Q&A

9:00 AM – 10:30 AM

Module 3: Developing and Documenting a QMS

• Creating Quality Policies and Procedures
• Setting Quality Objectives
• Record-keeping Requirements

10:30 AM – 10:45 AM

• Coffee/Tea Break

10:45 AM – 12:30 PM

Module 4: Internal Audits and Non-Conformity Management

• Steps to Conduct an Effective Internal Audit
• Identifying and Managing Non-Conformities
• Developing Corrective and Preventive Actions

12:30 PM – 1:30 PM

• Lunch Break

1:30 PM – 3:00 PM

Module 5: Certification Process and Maintaining a QMS

• Steps to Achieve ISO 9001 Certification
• Auditor Expectations and Assessment Criteria
• Maintaining and Improving a Certified QMS

3:00 PM – 3:15 PM

• Coffee/Tea Break

3:15 PM – 4:30 PM

Module 6: Practical Workshop and Role Play

• Mock Internal Audit: Planning, Execution, and Reporting
• Risk Assessment and Action Planning Exercise

4:30 PM – 5:00 PM

• Course Summary, Evaluation, and Closing Remarks
• Certificate Distribution

Methodology

1. Lectures & Presentations
   • Interactive sessions with visual aids and examples.
2. Group Activities
   • Discussions and collaborative exercises to apply theoretical knowledge.
3. Workshops & Case Studies
   • Real-world scenarios to simulate QMS challenges and solutions.
4. Practical Exercises
   • Hands-on tasks like developing policies, risk analysis, and mock audits.
5. Assessments
   • Quizzes, assignments, and practical tests to evaluate understanding and application.
6. Q&A Sessions
   • Dedicated time for addressing participant queries and challenges.

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Target Audience

• Quality Managers and Quality Assurance Professionals
• Process Managers and Supervisors
• Business Owners and Entrepreneurs
• Internal Auditors and ISO Coordinators