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The ISO 9001:2015 standard is a set of requirements that set the framework for an organization's quality management system. Clause 4 of the standard addresses the context of the organization. We'll give you a brief and easy-to-understand overview of this clause.
In clause 4, ISO 9001:2015 sets the requirements for the foundation of the ISO 9001 quality management system. The "context of the organization" is the business environment in which the company operates.
The first requirement is to identify external and internal strengths and weaknesses that are relevant to the company and the ISO 9001 quality management system.
Next, the needs and expectations of not only the customers but a wide range of "interested parties" (or stakeholders) need to be determined, and how they are relevant to the ISO 9001 quality management system.
Here you also need to decide on the scope of the ISO 9001 quality management system (and the certification). While it is possible to exclude functions and certain products or services, the scope will in most cases be the entire company.
Finally, you will need to use the process approach to determine the processes of the ISO 9001 quality management system. The quality management system will need to be implemented, maintained and continually improved upon.
The documentation of the quality management system must include certain procedures, as well as work instructions to ensure the effective operation and control of all processes. This documentation must be controlled to ensure the correct people have current revisions.
Records are established and controlled to provide evidence of a properly maintained quality management system.
There are another six clauses in ISO 9001:2015 that contain requirements for a quality management system. For an overview and an explanation of how they all fit together, please see our article on ISO 9001:2015 Requirements.
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