ISO 9001: Clause 4 - Context of the Organization

This template is designed to guide you through documenting Clause 4 of the ISO 9001 standard, which deals with understanding the organization and its context. Fill in the blanks to tailor the document to your organization's specific needs.

4.1 Understanding the Organization and its Context

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization must monitor and review information about these external and internal issues. Fill in the relevant issues below:

• External Issues:

1. [Fill in external issues that affect the organization]

• Internal Issues:

2. [Fill in internal issues that affect the organization]

4.2 Understanding the Needs and Expectations of Interested Parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
a) The interested parties that are relevant to the quality management system;
b) The requirements of these interested parties that are relevant to the quality management system.
Record below the relevant interested parties and their requirements:

• Interested Parties:

3. [Fill in interested parties]

• Requirements of Interested Parties:

4. [Fill in requirements]

4.3 Determining the Scope of the Quality Management System

The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider:
a) The external and internal issues referred to in 4.1;
b) The requirements of relevant interested parties referred to in 4.2;
c) The products and services of the organization.
Fill in the scope of your organization's QMS below:

• [Fill in the scope of the QMS]

4.4 Quality Management System and its Processes

The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. Organizations must:
a) Determine the processes needed for the quality management system and their application throughout the organization;
b) Determine the inputs required and the outputs expected from these processes;
c) Determine the sequence and interaction of these processes;
d) Determine and apply the criteria and methods needed to ensure the effective operation and control of these processes;
e) Determine the resources needed for these processes and ensure their availability;
f) Assign the responsibilities and authorities for these processes;
g) Address the risks and opportunities as determined in accordance with the requirements of 6.1;
h) Evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
i) Improve the processes and the quality management system.
Fill in the details below:

• Processes Required:

5. [Fill in the required processes]

• Process Inputs and Outputs:

6. [Fill in inputs and outputs]

• Process Sequence and Interactions:

7. [Fill in sequence and interactions]