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ISO 9001:2015 requirements are primarily contained in Clauses 4 to 10:

Clause 4 – Context of the Organization

The organization determines internal and external issues, interested parties, the scope of the QMS, and the processes needed for the QMS.

Clause 5 – Leadership

Top management demonstrates leadership and commitment, establishes the quality policy, assigns responsibilities, and promotes customer focus.

Clause 6 – Planning

The organization addresses risks and opportunities and establishes quality objectives and plans for achieving them.

Clause 7 – Support

This covers resources, competence, awareness, communication, and documented information.

Clause 8 – Operation

This addresses operational planning and control, customer requirements, design and development where applicable, external providers, production/service provision, release, and control of nonconforming outputs.

Clause 9 – Performance Evaluation

The organization monitors, measures, analyzes, and evaluates its QMS performance through activities such as customer satisfaction monitoring, internal audits, and management review.

Clause 10 – Improvement

The organization addresses nonconformities, implements corrective actions, and continually improves the QMS.