ISO 9001:2015 Quality Management System Requirements, We have broken down ISO 9001: 2015 to make it easier to understand and apply. ISO 9001: 2015 is the latest revision of ISO 9001. In this, there are 10 sections or clauses with supporting sub-sections (sub-clauses).
The requirements to be applied to QMS are addressed in sections 4-10. To successfully implement ISO 9001:2015 within your organization, you must meet the requirements in clauses 4 to 10 items.
Here is the summary of each clause.
This section introduces the purpose, principles and key concepts of the standard, including risk-based thinking and the process approach.
This section defines the scope of the 9001:2015 standard. In summary, the scope includes specifying requirements for a QMS of any organization.
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
Clause 3 : Terms and Definitions
Terminology used throughout this standard comes directly from ISO 9000:2015, Quality management systems – Fundamentals and vocabulary.
Determine external and internal issues, the needs and expectations of interested parties, quality management system scope and its processes.
Top management to demonstrate leadership and commitment, establish and communicate a quality policy, and ensure responsibilities and authorities are assigned, communicated and understood
Organizational Quality Management System Planning to address organizational risks, opportunities, changes and quality objectives.
Provide resource needs, ensure employees are competent and aware, and include documented information to support your quality management system.
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).
Monitor, measure, analyze, and evaluate your quality management system.
Select opportunities for improvement, take action against nonconformities, implement corrective actions as necessary, and continually improve your quality management system.