ISO 9001 Navigator Pro™
Quality management system guidance
Practical knowledge and expert guidance, ISO Navigator Pro™ is a free browser-based resource that gives you instant access to the quality management system knowledge you need.
Access multiple guidance interpretations, across different departments and offices, ideal for employees working remotely.
Planning
4.0 Organizational context
This is the 'Plan' part of the PDCA process. Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizational policies. This is often implemented using stated objectives, work instructions or procedures as required for consistent process output.
- Use the core terms now defined in Clause 3 of ISO 9001:2026, and ISO 9000:2026 for all other quality terms.
- Determine the external and internal issues relevant to the organization's purpose and strategic direction, including whether climate change is a relevant issue. Monitor and review these issues for change.
- Determine the relevant interested parties (stakeholders), their relevant requirements and which of those requirements will be addressed through the quality management system. Monitor and review stakeholder requirements for change.
- Base the scope of the management system on the external and internal issues - Clause 4.1, relevant interested party requirements - Clause 4.2, and the products and services your organization provides.
- Define the quality management system's processes, their sequence and interaction, and the criteria, methods and performance indicators needed to monitor and control them.
How to apply the latest quality management principles
Apply the quality management principles (QMPs) in the context of your business's own particular operations by reviewing and documenting its activities in the context of each quality management principle. The ISO 9000 quality management principles are embodied with in the individual requirements of ISO 9001 and the table below relates these principles to the applicable clauses and requirements:
| ISO 9000 Principles | ISO 9001 Base Clauses | Action & Compliance Summary | ISO 9001 Clauses |
| Process approach and engagement of people | Clause 2 Normative reference (ISO 9000:2026) | Use the 20 core terms now defined in clause 3 (for example, risk as the effect of uncertainty, documented information and continual improvement) and ISO 9000:2026 for all other terms, so that everyone shares the same quality vocabulary. | 3 Terms and Definitions |
| Process approach and Relationship management | 4.4.1 Processes (a, b, & c) | Determine the external and internal issues relevant to your organization's purpose and strategic direction, including whether climate change is a relevant issue. Monitor and review information about these issues. | 4.1 Understanding Context |
| Relationship management | 4.4.1 Processes (a, b, & c) | Determine the relevant interested parties (stakeholders), their relevant requirements, and which of those requirements your quality management system will address. Monitor and review this information for change. | 4.2 Interested Parties |
| Process approach | 4.4.1 Processes (a, b, & c) | Base the scope of the management system on the external and internal issues - 4.1, relevant interested party requirements - 4.2, and your products and services. State the types of products and services covered and justify any requirement you determine is not applicable. | 4.3 Determining Scope |
| Process approach | 4.4.1 Processes (a, b, c & d) | Define the management system processes, their inputs, outputs, sequence and interaction, and the criteria, methods and performance indicators needed to monitor and control them. | 4.4 Management System Processes |
Want to know more?
- Read our customer's feedback
- Client list - who's using our templates?
- How the templates are formatted and download examples
- Why we use turtle diagrams and process maps
- What's the difference between a process and a procedure?
- About documented information
SSL certification
A certificate guarantees the information your internet browser is receiving now originates from the expected domain - https://www.iso9001help.co.uk. It guarantees that when you make a purchase, sensitive data is encrypted and sent to the right place, and not to a malicious third-party.
Free PDCA guidance
ISO Navigator™ is our FREE online training tool that shows you how to apply the principles of PDCA to your operations. We also offer many helpful templates that get you on the road to documenting your management system, please visit the download page.