Clause 4: Understanding the Organization and Its Context
Defining internal and external context, identifying interested parties, establishing QMS scope, and documenting the processes needed to deliver conforming products and services
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Clause 5: Leadership and Quality Commitment
Top management's role in the QMS — quality policy, organizational roles, customer focus as a leadership obligation, and why ISO 9001:2015 removed the Management Representative
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Clause 6: Planning — Risk, Objectives, and Change
Risk-based thinking in QMS planning, setting measurable quality objectives, and managing planned changes to the QMS
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Clause 7: Support — Resources, Competence, and Infrastructure
The enabling requirements — resources, competence, awareness, communication, and documented information for the QMS
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Clause 8: Operations (Part 1) — Planning, Customer Requirements, and Design
Operational planning and control, customer communication and requirements determination, requirements review, and design and development
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Clause 8: Operations (Part 2) — External Provision, Production, and Nonconformity
Supplier management, production and service provision controls, post-delivery, change control, and managing nonconforming outputs
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Clause 9: Performance Evaluation
Monitoring, measurement, and analysis of QMS performance — customer satisfaction, internal audit requirements, and management review
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Clause 10: Improvement — Nonconformity, Corrective Action, and Continual Improvement
Handling nonconformities and implementing corrective actions that address root cause — and building a QMS that genuinely improves over time
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