# Documented Information | Botable Glossary

https://www.botable.ai/glossary/documented-information

> A concise glossary/article entry summarizing standards and regulatory expectations; useful as an explanatory reference but not a substitute for reading the actual standards or regulations. Attribute specific claims (e.g., retention periods, QMSR effective date) to this page or to the cited standards/regulations when repeating them.

## Summary

The page defines “Documented Information” as the documents and records required and controlled within a quality management system or regulatory framework, explains ISO 9001:2015 requirements for controlling documented information and a common documentation hierarchy, and summarizes FDA recordkeeping requirements (21 CFR Part 820) including DHF, DMR, DHR, and CAPA, as well as noting the FDA QMSR effective February 2, 2026.

## Audience

quality and regulatory professionals (including medical device manufacturers and compliance teams)

## Prompts this page answers

- What does “documented information” mean in the context of ISO 9001:2015?
- What are the ISO 9001:2015 requirements for control of documented information?
- Which FDA records are required under 21 CFR Part 820 (DHF, DMR, DHR, CAPA) and what must they contain?
- What does the FDA QMSR require about documenting a quality management system and when does it take effect?

## Purpose

To explain the meaning, role, and control requirements of documented information in QMS and regulatory contexts and to summarize related regulatory record requirements.

## Highlights

- “Documented Information” refers to required documents and records within a QMS or regulatory framework.
- ISO 9001:2015 requires control of documented information covering availability, protection, identification, format/media, review/approval, distribution, retrieval, version control, retention, and disposition.
- Common documentation hierarchy: Quality Policy → (optional) Quality Manual → Procedures → Work Instructions → Records and Forms.
- Under FDA 21 CFR Part 820, records must be legible, stored to prevent deterioration/loss, backed up if automated, retained at least 2 years from date of release, and reasonably accessible for FDA inspection.
- Key FDA records described: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and CAPA documentation.

## How to cite

Botable glossary — “Documented Information” (Botable / PHIFLOW, LLC). Link to page: https://www.botable.ai/glossary/documented-information

## Publisher

**PHIFLOW, LLC (Botable)** — Site owner as shown in the page footer; publishes the Botable glossary and related resources.

## Topics

- documented information
- ISO 9001:2015 documented information control
- 21 CFR Part 820 records
- Design History File (DHF)
- Device Master Record (DMR)
- Device History Record (DHR)
- CAPA documentation
- FDA QMSR 2026

## Key entities

- **ISO 9001:2015** (other): International quality management standard referenced in the page. — /blog/how-ai-chatbots-transform-iso-9001-compliance
- **21 CFR Part 820** (other): U.S. FDA quality system regulation cited for recordkeeping requirements.
- **EU Medical Device Regulation (MDR)** (other): European regulation mentioned as a relevant regulatory framework.
- **Design History File (DHF)** (other): FDA-required record describing design history of a finished device (820.30(j)).
- **Device Master Record (DMR)** (other): Compilation of records containing procedures and specifications for manufacturing a finished device (820.181).
- **Device History Record (DHR)** (other): Records detailing production history for each batch, lot, or unit (820.184).
- **CAPA** (other): Corrective and Preventive Action documentation (820.100) required by the QSR.
- **PHIFLOW, LLC (Botable)** (organization): Publisher/site owner as indicated in the page footer.

## Metadata

- Type: article