ISO 9001 - Clause 7.5.1 General

ISO 9001 Clause 7.5.1 requires organizations to maintain documented information that defines:

1. Characteristics of the products and services to be produced or provided:
- This includes documentation specifying the product/service requirements, such as design specifications, customer requirements, regulatory requirements, etc.

2. Activities to be performed:
- Documented procedures, work instructions, or process maps outlining the steps and activities required for production and service provision.

3. Results to be achieved:
- Documentation specifying the expected outcomes, including quality objectives, performance indicators, or acceptance criteria for the products/services.

The documented information serves as a basis for communicating requirements, ensuring consistent operations, facilitating monitoring and measurement, and providing evidence of conformity.

It is important to note that the extent of documented information required depends on the size and complexity of the organization, as well as the competence of personnel involved in the processes. The documented information should be maintained, controlled, and made available to the relevant personnel to support the effective planning, operation, and control of the production and service provision processes.

By maintaining documented information, organizations can ensure that their production and service provision activities are carried out in a controlled and consistent manner, contributing to the overall effectiveness of their Quality Management System (QMS) and the ability to consistently deliver conforming products and services.