ISO 9001:2015 Requirements for a Quality Management System

ISO 9001 states the requirements for your Quality Management System (QMS). There are 10 sections (clauses) in ISO 9001, with additional subclauses related to the Plan-Do-Check-Act system. However, only sections 4-10 contain requirements that are auditable. 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. Learn more about ISO 9001:2015 requirements with our Online Requirements Training.

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.  Learn More:

Section 00: Introduction

• Seven Quality Principles

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:

• Section 01: Scope of ISO 9001:2015

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.

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. Learn more:

Section 04: Context of the Organization

• Considering Climate Change in ISO 9001
• ISO 9001 Processes, Procedures and Work Instructions
• Quality Management System Scope
  • ISO 9001:2015 Exclusions and Requirements
• Relevant Interested Parties
• What is a Process Approach?

Section 5: Leadership
Section 5 of the ISO 9001:2015 requirements cover 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. Learn More:

Section 05: Leadership’s Responsibilities

• Leadership’s Responsibilities and Commitment
• Quality Policy

Section 6: Planning
Clause 6 of the ISO 9001:2015 requirements cover Organizational Quality Management System planning to address organizational risks, opportunities, changes and quality objectives. Learn More:

Section 06: Planning for the Quality Management System

• ISO 9001:2015 Risk Management
• Planning to Achieve Quality Objectives

Section 7: Support
Clause 7 of the ISO 9001:2015 requirements cover 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. Learn More:

Section 07: Supporting the Quality Management System

• ISO 9001 Resource Management
• ISO 9001:2015 Documented Information
  • Facing the Challenge of Documenting your ISO System

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). Learn More:

Section 08: Quality Management System Operations

• Control of External Providers
• Customer Communication
• Identification and Traceability
• Incoming Inspection: Do we have to inspect everything?
• Objects, Outputs, Products and Services

Section 9: Performance Evaluation
ISO 9001 requires your organization’s QMS to monitor, measure, analyze, and evaluate your quality management system. Learn More:

Section 09: Evaluating the Quality Management System’s Performance

• Customer Satisfaction
• Effective Management Review
• ISO 9001 Internal Audit
  • Auditing without a Procedure

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. Learn More:

Section 10: Improving the Quality Management System

• Continual Improvement
• Nonconformity and Corrective Action
• What is Root Cause Analysis (RCA)?