Course Objective
To equip learners with a thorough understanding of ISO 9001:2015 requirements, enabling them to implement, manage, or audit a QMS in any organization.
Module 1: Introduction to ISO 9001
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What is ISO?
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Evolution of ISO 9001
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Benefits of ISO 9001 Certification
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Key Terms and Definitions
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Structure of ISO 9001:2015 (Annex SL)
Outcome: Understand the purpose, history, and importance of ISO 9001.
Module 2: Understanding the ISO 9001:2015 Standard
Breakdown of the Clauses (4–10):
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Clause 4: Context of the Organization
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Clause 5: Leadership
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Clause 6: Planning
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Clause 7: Support
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Clause 8: Operation
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Clause 9: Performance Evaluation
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Clause 10: Improvement
Each clause should include:
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Explanation of requirements
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Practical examples
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Common pitfalls
Outcome: Detailed understanding of each clause and how to apply it.
Module 3: Implementing a QMS
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Steps to implement ISO 9001 in an organization
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Gap analysis
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Documented Information (procedures, policies, work instructions)
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Risk-based thinking
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Quality Objectives & KPIs
Outcome: Learn how to initiate and structure an ISO 9001 implementation project.
Module 4: Internal Audits
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The role of audits in ISO 9001
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Planning and preparing for an internal audit
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Conducting and reporting audits
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Audit findings and corrective actions
Outcome: Ability to perform internal audits aligned with ISO 19011.
Module 5: Certification Process
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Choosing a certification body
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Stage 1 & Stage 2 audits
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Maintaining certification
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Surveillance and recertification audits
Outcome: Know how to navigate and prepare for ISO 9001 certification.
Module 6: ISO 9001 and Continuous Improvement
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Corrective and preventive actions
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Root cause analysis tools
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PDCA (Plan-Do-Check-Act) cycle
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Using QMS for business improvement