ISO 9001:2015 Requirements for a Quality Management System
Here we’ve broken down the ISO 9001:2015 requirements of the standard to make it easier to understand and put into action. ISO 9001:2015 is the latest revision of ISO 9001. The ISO 9001 requirements encompass 10 sections (also known as 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. One of the major changes between ISO 9001:2008 and ISO 9001:2015 was the clause structure. To learn more about the clause structure, read our article: ISO 9001:2015 in Detail: The Clause Structure.
Summary of each section of ISO 9001:2015 Requirements
Section 0: Introduction
This section introduces the purpose, principles and key concepts of the standard, including risk-based thinking and the process approach.
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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.
Learn More: 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.
Learn More: 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.
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Section 4: Context of the Organization
When you are implementing your Quality Manual System (QMS), the first step for ISO 9001 requirements is to thoughtfully align your business objectives and intent with the QMS. Determine external and internal issues, the needs and expectations of interested parties, quality management system scope and its processes.
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Section 5: Leadership
Section 5 of the ISO 9001:2015 requirements covers leadership responsibility. Top management must demonstrate leadership and commitment, establish and communicate a quality policy, and ensure responsibilities and authorities are assigned, communicated and understood.
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Section 6: Planning
Clause 6 of the ISO 9001:2015 requirements covers Organizational Quality Management System planning to address organizational risks, opportunities, changes and quality objectives.
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Section 7: Support
Clause 7 of the ISO 9001:2015 requirements covers the resources needed for the QMS this covers: providing resources, ensures employees are competent and aware, and includes documented information to support your quality management system.
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Section 8: Operation
Clause 8 covers the 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).
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Section 9: Performance Evaluation
ISO 9001 requires your organization’s QMS to monitor, measure, analyze, and evaluate your quality management system.
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Section 10: Improvement
ISO 9001:2015 requirements for clause 10 are based around continual improvement. Select opportunities for improvement, take action against nonconformities, implement corrective actions as necessary, and continually improve your quality management system.
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