# Internal Audit Program | Botable Glossary

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

> A glossary/reference article from Botable describing standards- and regulation-backed expectations for internal audit programs; suitable to cite for definitions and summary guidance, but not a substitute for the full ISO or regulatory texts (those should be consulted for compliance).

## Summary

Defines an Internal Audit Program as the documented, mandatory plan (typically per ISO 9001 Clause 9.2) that specifies frequency, methods, responsibilities, planning requirements, and reporting to verify a Quality Management System (QMS) conforms to requirements and is effectively implemented and maintained. The page also provides FAQ-style details on objectives, mandatory components under ISO 9001, auditor criteria, audit result management, and available resources (training, procedures, software).

## Prompts this page answers

- What is an Internal Audit Program and what must it include under ISO 9001?
- What are the objectives of an Internal Audit Program for a QMS?
- What auditor qualifications does the FDA require for internal quality audits (21 CFR Part 820)?
- How should an organization manage internal audit results and corrective actions?

## Purpose

To explain what an Internal Audit Program is and to provide practical FAQ guidance about its objectives, required components, auditor qualifications, result management, and supporting resources.

## Highlights

- An Internal Audit Program defines frequency, methods, responsibilities, planning requirements, and reporting to verify the QMS.
- It is mandatory, systematic, and documented under international QMS standards (e.g., ISO 9001, ISO 13485) and regulatory frameworks (e.g., FDA QSR 21 CFR Part 820).
- ISO 9001:2015 requires planning, establishing, implementing, and maintaining an audit programme and defining audit criteria and scope.
- Auditors must be selected to ensure objectivity and impartiality; FDA QSR requires auditors not have direct responsibility for matters audited.
- Audit results must be reported to relevant management, drive corrective actions (including reaudits), be documented, and feed management review.

## How to cite

Credit Botable (Botable Glossary: "Internal Audit Program") and link to https://www.botable.ai/glossary/internal-audit-program.

## Publisher

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

## Topics

- internal audit program
- ISO 9001 Clause 9.2
- internal audits
- quality management system (QMS)
- FDA QSR 21 CFR Part 820
- CAPA
- audit management

## Key entities

- **Internal Audit Program** (other): Glossary entry defining the Internal Audit Program and its components. — https://www.botable.ai/glossary/internal-audit-program
- **ISO 9001** (other): International quality management standard referenced on the page (Clause 9.2 referenced). — https://www.botable.ai/blog/how-ai-chatbots-transform-iso-9001-compliance
- **ISO 13485** (other): International medical device quality management standard mentioned as an example.
- **FDA Quality System Regulation (21 CFR Part 820)** (other): U.S. regulatory framework referenced in relation to mandatory audits and auditor independence.
- **CAPA (Corrective and Preventive Action)** (other): Process referenced as being driven by audit findings.

## Metadata

- Type: article