Quality System Audits

A Quality Management System (QMS) is only as strong as its compliance.

Regular audits are essential—not just to confirm that your organization is following established procedures, but to ensure those procedures are effective in achieving your operational objectives.

At RQMIS, we provide comprehensive internal auditing services aligned with:

ISO 13485
21 CFR 820
2017/745 EU MDR
Other international regulations

We also offer pre-certification readiness audits to prepare your organization for:

Notified Body certification audits
FDA inspections

Additionally, our consultants conduct Gap Analyses, which involve a thorough internal audit of your quality system to assess compliance with specific standards, such as ISO 13485.

This process often begins with a one-day desk audit of your quality system documentation. The goal is to ensure your organization has the necessary processes in place to meet regulatory requirements effectively.

Partner with RQMIS to ensure your QMS remains compliant, efficient, and ready for any audit or inspection.

After the initial desk audit, RQMIS conducts a three-day on-site audit to evaluate your quality system's compliance with current regulations and internal documentation. This process includes a thorough review of quality records to ensure alignment between documented procedures and actual practices.

At the conclusion of the audit, we hold a final management discussion to highlight the strengths and weaknesses of your system. A detailed final report will outline:

Major and minor noncompliance issues
Actionable recommendations for improvement

Comprehensive Audit Services

RQMIS offers a full range of audit services to ensure your Quality Management System (QMS) remains effective, compliant, and ready for scrutiny:

Internal Audits (based on a scheduled cadence)
Supplier Audits
Compliance Audits
External Audits (conducted on your behalf for due diligence or gap assessment in new business arrangements)

Additionally, our experts can: