documented information

Documented information is a formal term used in management system standards for information that an organization must control and maintain, and in some cases retain, to ensure that its processes are planned, carried out, and demonstrated as intended.

It includes both the information itself and the medium used to store it. In industrial and regulated environments, documented information can be paper-based, electronic, or held in specialized systems such as MES, QMS, ERP, LIMS, PLM, or electronic batch record systems.

What documented information typically includes

Depending on the management system and standard, documented information commonly covers:

• Maintained documented information that describes how work should be done, such as procedures, work instructions, specifications, recipes, test methods, and drawings.
• Retained documented information that provides evidence that work was done as required, such as records, logs, batch or device history records, calibration and maintenance reports, inspection results, PPAP submissions, and training records.

In practice, documented information also includes associated metadata needed to show control and traceability, such as version, author, approval status, effective date, and applicable process or product.

Use in manufacturing and regulated operations

In manufacturing environments, documented information commonly appears as:

• Controlled SOPs, work instructions, and job aids used on the shop floor.
• Approved product and process specifications tied to part numbers or routings.
• Quality records such as nonconformance reports, CAPA records, and inspection data.
• Production records, including batch records, route cards, build histories, and test results.
• Supplier-related documents such as PPAP packages, certificates of analysis, and change notifications.
• System configuration and validation evidence for MES, QMS, and other critical systems.

These items are usually managed through document control and records management processes, including version control, change review, approval workflows, access control, retention rules, and archival or disposal.

Operational meaning

Operationally, treating something as documented information typically means:

• It is created according to a defined process, often with identified roles and approvals.
• It is stored in a controlled location (document management system, QMS, DMS, or similar).
• It is versioned so that obsolete information is identified and withdrawn from use.
• It is retrievable as objective evidence during internal reviews, customer audits, or regulatory inspections.

Common confusion

• Documented information vs. documents: In many standards, “documented information” replaced separate references to “documents” and “records.” Documents that describe what should be done and records that show what was done are both forms of documented information.
• Documented information vs. data: Not all data in a system is necessarily treated as documented information. Only the data that an organization decides or is required to control and retain as part of its management system falls under documented information.

Link to PPAP and quality system context

In contexts such as PPAP or sector-specific requirements built on top of a general quality standard, the PPAP submission and supporting evidence (process flow diagrams, control plans, FMEAs, measurement system studies, capability data, and approvals) are treated as documented information. They are typically integrated into the broader document control, change control, and records retention processes defined by the organization’s quality or integrated management system.