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ISO 9001:2015 Quality Management System Requirements

Here we’ve broken down the ISO 9001:2015 standard to make it easier to understand and put into action. ISO 9001:2015 is the latest revision of the ISO 9001 standard. In it, there are 10 sections (clauses) with supporting subsections (subclauses). The requirements to be applied to your quality management system (QMS) are covered in sections 4-10. To successfully implement ISO 9001:2015 within your organization, you must satisfy the requirements within clauses 4-10 along with meeting customer and applicable statutory and regulatory requirements. Expand each section for a summary of the clause and a link to more information.

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Section 0: Introduction
This section introduces the purpose, principles and key concepts of the standard, including risk-based thinking and the process approach. <ISO 9001 Introduction>
Section 1: Scope
This section defines the scope of the 9001:2015 standard. In summary, the scope includes specifying requirements for a QMS of any organization. <ISO 9001 Explained>
Section 2: Normative References
The supporting standard referenced in ISO 9001:2015 and is indispensable for its application is ISO 9000:2015 which covers terminology and fundamentals. This and other supporting standards make up the 9000 series. <ISO 9001 Supporting Standards>
Section 3: Terms and Definitions
Terminology used throughout this standard comes directly from ISO 9000:2015, Quality management systems – Fundamentals and vocabulary. <ISO 9000 Explained>
Section 4: Context of the Organization
Determine external and internal issues, the needs and expectations of interested parties, quality management system scope and its processes. <ISO 9001 Context>
Section 5: Leadership
Top management to demonstrate leadership and commitment, establish and communicate a quality policy, and ensure responsibilities and authorities are assigned, communicated and understood. <ISO 9001 Leadership>
Section 6: Planning
Organizational Quality Management System Planning to address organizational risks, opportunities, changes and quality objectives. <ISO 9001 Planning>
Section 7: Support
Provide resource needs, ensure employees are competent and aware, and include documented information to support your quality management system. <ISO 9001 Support>
Section 8: Operation
Plan and control processes needed to meet the requirements for products and services (Design and development, external providers, production and service provision, release of products and services, nonconforming outputs). <ISO 9001 Operation>
Section 9: Performance Evaluation
Monitor, measure, analyze, and evaluate your quality management system. <ISO 9001 Performance Evaluation>
Section 10: Improvement
Select opportunities for improvement, take action against nonconformities, implement corrective actions as necessary, and continually improve your quality management system. <ISO 9001 Improvement>

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