# Internal Audit | Botable Glossary

https://www.botable.ai/glossary/internal-audit

> Use this page as a glossary-style reference for the definition and high-level requirements of internal audits within QMS contexts; it summarizes regulatory and standards references and FAQ-style explanations but is not a primary legal/regulatory source — attribute claims to Botable and consult official standards/regulations for compliance decisions.

## Summary

An internal audit is a systematic, independent examination of an organization’s quality system or processes performed at defined intervals to verify compliance with procedures and effectiveness in achieving quality objectives. The page explains objectives, regulatory/standard requirements (FDA QSR, ISO 9001, ISO 13485), auditor criteria (independence and training), audit program planning and documentation, links to CAPA, and available training resources.

## Audience

quality and regulatory professionals (teams responsible for QMS compliance)

## Prompts this page answers

- What is an internal audit in a quality management system and what are its main objectives?
- What regulatory standards require internal audits for medical device manufacturers?
- Who should conduct internal audits to ensure objectivity and what auditor qualifications are expected?
- What must an organization include when planning and documenting an internal audit program?
- How do internal audits relate to CAPA and management review?

## Purpose

To define and explain the concept, requirements, objectives, planning, roles, and regulatory context of internal audits within quality management systems.

## Highlights

- Internal audit: a systematic, independent examination performed at defined intervals to determine compliance and effectiveness of the quality system.
- Regulatory/standards referenced include FDA Quality System Regulation (21 CFR Part 820), ISO 9001:2015, and ISO 13485.
- Audits must be planned, with defined frequency, methods, responsibilities, criteria, scope, and documented results.
- Audits are a primary trigger for corrective and preventive actions (CAPA) and feed management review; reaudits may be required to verify corrective actions.
- Auditors should be independent of the activities being audited and organizations must provide trained personnel and adequate resources for audits.

## How to cite

Credit Botable and link to https://www.botable.ai/glossary/internal-audit.

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- internal audit
- quality audit
- ISO 9001 internal audit
- FDA Quality System Regulation 21 CFR Part 820
- internal audit program

## Key entities

- **FDA Quality System Regulation (QSR)** (organization): Regulatory framework referenced (21 CFR Part 820) governing quality system requirements for medical devices.
- **ISO 9001:2015** (other): International standard referenced for internal audit requirements (Clause 9.2).
- **ISO 13485** (other): Medical device quality management standard referenced in the page.
- **HCT/P** (other): Human Cells, Tissues, or Cellular or Tissue-Based Products — the page references quality audit requirements for HCT/P establishments and CGTP.
- **CGTP** (other): Core Current Good Tissue Practice — mentioned in the HCT/P context.

## Metadata

- Type: article