QM Audit Checker

QM Audit Checker is a tool from CertHub designed for Quality Managers and Regulatory Affairs teams preparing for Quality Management System (QMS) audits. It simulates a real QMS audit, checks documentation against applicable regulatory standards, and produces a corrective actions plan, reducing reliance on manual review processes.

The tool addresses common challenges in audit preparation, including inconsistent manual reviews, slow turnaround, and the risk of overlooking non-conformities. CertHub applies AI agents to perform structural and semantic checks across QMS documentation, flagging issues against ISO 13485, MDR Annex IX, FDA 21 CFR Part 820, ISO 14971, and other applicable standards.

Supported Standards and Scope

• ISO 13485 (Quality Management Systems for medical devices)
• MDR Annex IX
• FDA 21 CFR Part 820
• ISO 14971 and other applicable standards
• Scope is configurable based on device classification and the specific QMS modules under review

Four Stages of QMS Audit Simulation

1. Scope & Standards Definition: Users define device classification, applicable standards, and the QMS modules in scope. The tool guides users through this step to align the simulation with their specific regulatory context.
2. QMS Document Upload: Users upload SOPs, work instructions, procedures, and records. Accepted formats include PDFs, Word files, Excel sheets, and scanned documents, with no reformatting or manual indexing required.
3. Automated Audit Simulation: AI agents perform clause-by-clause checks across the entire QMS, identifying missing links, contradictions, and non-conformities in a manner consistent with how a real auditor would review documentation.
4. Audit-Ready Report & Corrective Actions Plan: The tool generates a full assessment report including severity-ranked findings, specific corrective actions guidance, and a traceable audit trail.

Key Capabilities

• Automated detection of non-conformities against multiple regulatory frameworks
• Severity ranking of audit findings
• Corrective actions guidance included in the output report
• Full traceability throughout the QMS review process
• Support for a wide range of document formats without requiring reformatting

QM Audit Checker is part of CertHub's broader software offering for the MedTech industry, which also includes tools for Conformity Checking and Gap Analysis, UDI management and EUDAMED, Technical Documentation, and QMS support. The platform is available with a demo booking option for teams looking to evaluate the tool in the context of their own QMS.