# A Deep Dive Into ISO 13485 Audits | Botable

https://www.botable.ai/blog/iso13485-audits

> Informational blog post from a company (Botable) offering practical guidance; useful as introductory guidance and checklist-style advice but should be treated as general informational content rather than formal regulatory text or certification guidance. Attribute claims to the Botable Field Notes post when quoting.

## Summary

This Field Note explains what to expect in ISO 13485 audits for medical device manufacturers, outlines common nonconformities auditors find, describes the CAPA process, and offers practical preparation tips such as documentation review, staff training, supplier evaluation, design checks, and mock audits.

## Audience

Quality and regulatory professionals in medical device manufacturing

## Prompts this page answers

- What should a medical device manufacturer do to prepare for an ISO 13485 audit?
- What are common nonconformities found in ISO 13485 audits?
- How does CAPA work in the context of ISO 13485 audits?
- What checklist items should I include when running a mock ISO 13485 audit?

## Purpose

To inform and guide medical device manufacturers and quality teams on preparing for and responding to ISO 13485 audits.

## Highlights

- Audits (internal and external) are essential to verify a medical device QMS meets ISO 13485.
- Key audit preparation steps: review QMS documentation, train staff, evaluate suppliers, check product design, and run a mock audit.
- Common nonconformities include lack of documentation, poorly trained staff, insufficient control of outsourced processes, product design issues, and non-conforming product.
- CAPA involves identification, investigation (root cause), implementation of corrective action, and preventive actions to stop recurrence.

## How to cite



## Publisher



## Topics

- ISO 13485 audits
- medical device QMS
- CAPA (corrective and preventive actions)
- audit preparation
- common nonconformities

## Key entities

- **ISO 13485** (other): International standard for quality management systems for medical devices (mentioned throughout the article).
- **CAPA** (other): Corrective and preventive actions process described in the article.
- **Botable** (organization): Publisher of the Field Notes blog post (site branding and navigation). — https://www.botable.ai
- **1351 Washington Boulevard, Stamford, CT 06902** (location): Address displayed in the site footer.

## Metadata

- Type: article