What are the ISO 9001 Requirements?
Understanding ISO 9001 requirements is essential for organisations seeking certification to this internationally recognised quality management standard. This guide breaks down the ISO 9001 certification requirements, explains the clause structure, and provides a comprehensive checklist. Whether you’re exploring ISO 9001 training courses or preparing for certification, this article covers everything you need to know about what is ISO 9001 and its requirements.
In this article:
ISO 9001 Requirements Checklist
The ISO 9001 2015 requirements are structured around the Plan-Do-Check-Act (PDCA) cycle, comprising four key requirement categories containing ten clauses. Clauses 1-3 provide introductory information, while clauses 4-10 contain the auditable ISO 9001 requirements that organisations must fulfil for certification.
The ten clauses are organised as follows:
- Scope
- Normative references
- Terms and definitions
- Context of the organization
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvement
ISO 9001 Planning Requirements
The planning phase establishes the foundation for your quality management system. These clauses address organisational context, leadership commitment, and strategic planning:
1. Scope – Defines the boundaries and applicability of the standard.
2. Normative references – References to other standards essential for application.
3. Terms and definitions – Refers to ISO 9000 for quality management vocabulary.
4. Context of the organization
- 4.1 Understanding the organization and its context
- 4.2 Understanding the needs and expectations of interested parties
- 4.3 Determining the scope of the quality management system
- 4.4 Quality management system and its processes
5. Leadership
- 5.1 Leadership and commitment
- 5.1.1 Leadership and commitment for the quality management system
- 5.1.2 Customer focus
- 5.2 Policy
- 5.2.1 Establishing the quality policy
- 5.2.2 Communicating the quality policy
- 5.3 Organizational roles, responsibilities and authorities
6. Planning
- 6.1 Actions to address risks and opportunities
- 6.2 Quality objectives and planning to achieve them
- 6.3 Planning of changes
ISO 9001 Doing Requirements
The doing phase covers resource management and operational controls. These clauses ensure organisations have the capability to deliver conforming products and services:
7. Support
- 7.1 Resources
- 7.1.1 General
- 7.1.2 People
- 7.1.3 Infrastructure
- 7.1.4 Environment for the operation of processes
- 7.1.5 Monitoring and measuring resources
- 7.1.6 Organizational knowledge
- 7.2 Competence
- 7.3 Awareness
- 7.4 Communication
- 7.5 Documented information
- 7.5.1 General
- 7.5.2 Creating and updating documented information
- 7.5.3 Control of documented information
8. Operation
- 8.1 Operational planning and control
- 8.2 Requirements for products and services
- 8.3 Design and development of products and services
- 8.4 Control of externally provided processes, products and services
- 8.5 Product and service provision
- 8.6 Release of products and services
- 8.7 Control of nonconforming outputs
ISO 9001 Checking Requirements
The checking phase focuses on monitoring and measuring QMS performance:
9. Performance evaluation
- 9.1 Monitoring, measurement, analysis and evaluation
- 9.1.2 Customer satisfaction
- 9.2 Internal audit
- 9.3 Management review
ISO 9001 Acting Requirements
The acting phase drives continual improvement of the quality management system:
10. Improvement
- 10.1 General
- 10.2 Nonconformity and corrective action
- 10.3 Continual improvement
Non-Applicable ISO 9001 Requirements
Organisations may exclude certain ISO 9001 requirements if they do not apply to their operations, provided this does not affect their ability to ensure product or service conformity. Common exclusions include clause 8.3 (Design and development) for organisations that do not design their own products.
Any exclusions must be justified and documented within the QMS scope. Is a quality manual required for ISO 9001? Under the 2015 version, a formal quality manual is no longer mandatory, though organisations must maintain documented information to support their processes and demonstrate conformity.
Enrol in an ISO 9001 Training Course
Understanding ISO 9001 IT requirements and implementation demands professional training. Our CQI and IRCA certified courses provide the knowledge needed to interpret requirements, conduct audits, and maintain effective quality management systems.
Choose from our range of programmes:
- ISO 9001 Lead Auditor Course – Lead third-party certification audits
- ISO 9001 Internal Auditor Course – Conduct effective internal audits
- ISO 9001 Foundation Course – Build foundational QMS knowledge
Ready to advance your quality management expertise? Explore our ISO 9001 training courses today.
Frequently Asked Questions
The seven principles are: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. These principles underpin the standard’s requirements.
The five core elements align with PDCA: quality policy (Plan), resource management (Do), product realisation (Do), measurement and analysis (Check), and continual improvement (Act).
In the UK, ISO 9001 is adopted as BS EN ISO 9001:2015+A1:2024. The requirements are identical to the international version, with BSI providing the official UK publication. A tracked changes version is also available.
ISO 9001:2015 no longer mandates specific procedures. Instead, organisations must maintain “documented information” as required by the standard. Previously mandatory procedures included control of documents, control of records, internal audit, control of nonconforming product, corrective action, and preventive action.