ISO 9001 Clause 7.5 Documented Information | Auditor Training Online

Understanding Documented Information
Documented information is most often used within organizations as either a form of communication or as a way to provide the evidence required by audits. However, under ISO 9001:2015 standards, documented information must meet four main objectives:

1. Communication of Information - Documentation must be able to communicate information in relation to the organization’s various systems and processes and the steps needed to perform them
2. Evidence of Conformity - ISO 9001 requires that organizations have documentation in the form of records that support that they, in fact, have met ISO 9001 requirements
3. Knowledge Sharing - An organization’s documents must be written in a way that employees across the company will be able to understand
4. Preserve the organization’s Experiences – Documentation should serve as some form of history of the organization’s experiences. For example, one form of documentation may be the technical specifications of an early version of a product. This information can then be used later to serve as a baseline for improving or updating the product

Types of Documented Information

Similarly to how there are several types of mediums that your documentation can be in, there is also a range of the type of formats your information can have as well. Although ISO 9001 does not necessarily require a specific format, you can choose to structure your documentation’s content as the following:

Organizational charts
Process maps, flow charts, and/or process descriptions
Procedures
Work and/or test instructions
Specifications
Internal communications
Production schedules
Approved supplier lists
Test and inspection plans
Quality plans and manuals
Strategic plans
Forms

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