What are the ISO 9001: 2015 Quality Management System Requirements?

iso 9001 requirements

Introduction to ISO 9001 Requirements

In this article, we have listed the requirements of the ISO 9001 :2015 standard to make it easier to understand and implement. ISO 9001:2015 is the latest revision of ISO 9001. The ISO 9001 requirements consist of 10 sections with supporting subsections. The requirements to be applied to your quality management system (QMS) are covered in sections 4-10. To successfully implement ISO 9001:2015 in your organization, you must meet the requirements in clauses 4-10, in addition to meeting customer and applicable legal and regulatory requirements. One of the biggest changes between ISO 9001:2008 and ISO 9001:2015 was the clause structure. To learn more about the clause structure, stay tuned to the article Clause Structure of ISO 9001:2015 .

Summary of each part 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.

• Chapter 00: Introduction to the Seven Quality Principles (click for details)

Section 1: Scope This section defines the scope of the 9001:2015 standard. In summary, the scope includes specifying the requirements for any organization's QMS.

• Part 01: Scope of ISO 9001: 2015 (more on that later)

Part 2: Normative References The supporting standard referenced in ISO 9001:2015 is ISO 9000:2015, which covers the indispensable terminology and fundamentals for its application. These and other supporting standards form the 9000 series.

• ISO 9001 Support Standards (we will provide the link later)

Part 3: Terms and Definitions The terminology used throughout this standard is taken directly from ISO 9000:2015 , Quality management systems – Fundamentals and vocabulary.

Section 4: Organizational Context When you implement your Quality Manual (QMS) for ISO 9001 requirements, the first step is to carefully align your business objectives and intent with the QMS. It identifies internal and external issues, the needs and expectations of interested parties, and the quality management system scope and processes.

1. Chapter 04: The Content of the Organization (more on that later)

• ISO 9001 Processes , Procedures and Work Instructions

• Scope of Quality Management System

• ISO 9001:2015 Exclusions and Requirements

• Related Interested Parties

• What is the Process Approach?

Part 5: Leadership Part 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 that responsibilities and authorities are assigned, communicated, and understood. Detail headings (more on this later) ;

• Responsibilities and Commitment of Leadership

• Quality policy

iso 9001 Planning

Part 6: Planning Clause 6 of the ISO 9001:2015 requirements covers the planning of the Corporate Quality Management System to address corporate risks, opportunities, changes and quality objectives.

Detail headings (we will go into detail later) ;

• 9001: 2015 Risk Management

• Planning to Achieve Quality Goals

Section 7: Support Clause 7 of the ISO 9001:2015 requirements covers the resources required for the QMS within this scope: resourcing ensures that employees are competent and aware and includes documented information to support your quality management system. Detail headings (more on this later) ;

• ISO 9001 Resource Management

• ISO 9001: 2015 Documented Information

• Comparing Your ISO System to the Certification Problem

Section 8: Operations Section 8 covers the planning and control processes required to meet product and service requirements (design and development, external suppliers, production and service delivery, release of products and services, nonconforming outputs). Detail headings (more on this later) ;

• Control of External Suppliers

• Identification and Traceability

• Objects, Outputs, Products and Services

Part 9: Performance Evaluation ISO 9001 requires your organization to monitor, measure, analyze and evaluate your Quality Management system. Detail headings (more on that later) :

1. Evaluating the Performance of the Quality Management System

• Customer satisfaction

• Effective Management Review

• ISO 9001 Internal Audit

• Audit Without Procedure

Part 10: Improvement The ISO 9001:2015 requirements for Clause 9 are based on continual improvement. Select opportunities for improvement, take action against nonconformities, implement necessary corrective actions, and continually improve your quality management system.

1. Improving the Quality Management System

• Continuous development

• Nonconformity and Corrective Action

• What is Root Cause Analysis (RCA)?

I hope it will be useful..