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. There are 10 sections (clauses) with supporting sections (subclauses). The requirements to be applied to your quality management system (QMS) are covered in sections 4-10. To successfully implement ISO 9001:2015 quality standard within your organization, you must satisfy the requirements within clauses 4-10. Expand each section for a summary of the clause and a link to more information.

 

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>

ISO 9001 All in One Package

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