Context of the Organisation Under ISO 9001 Quality Management

ISO 9001 Clause 4 - Context of the Organisation

Clause 4 is where the quality management system starts. It asks the organisation to look outward at the issues and parties that affect its quality activities, then turn those findings into a defined scope for the management system itself. The clause splits into four sub-clauses, each covered in its own article below.

Sub-clauses of ISO 9001 Clause 4

Clause 4.1 - Understanding the Organisation and Its Context requires the organisation to identify the internal and external issues that are relevant to its purpose and that could affect the intended outcomes of the QMS.

Clause 4.2 - Understanding the Needs and Expectations of Interested Parties requires the organisation to identify its interested parties and the relevant requirements of those parties that affect the quality management system.

Clause 4.3 - Determining the Scope of the QMS requires the organisation to set the boundaries and applicability of the QMS as a documented scope statement covering the products, services, sites and activities within the management system.

Clause 4.4 - Quality Management System and Its Processes requires the organisation to establish, implement, maintain and continually improve the QMS, including the processes needed and their interactions across the management system.