Quality System Audits

A quality system is nothing without compliance. Periodic checks, or audits, of your quality system effectiveness, are critical. Audits do not simply confirm that your organization is following its procedures - an audit should confirm that your procedures are effective in achieving your intended operational objectives.

We offer internal auditing in accordance with ISO 13485, 21 CFR 820, 2017/745 EU MDR, and most international regulations. In addition, we offer pre-certification readiness audits to make sure your company is ready for a certification audit by the Notified Bodies and/or periodic FDA inspections.

Our consultants often perform Gap Analyses for clients, which consist of internal audits of their quality systems to determine the level of compliance with certain standards, for example, ISO13485. The process typically begins with a one-day desk audit of the client's quality system documentation. The goal of this audit is to confirm that the client has the necessary processes in place to address the regulatory requirements.

After this desk audit, a three-day on-site audit will be conducted to determine how compliant their quality system is with both the current regulations and their own documentation through a review of their quality records. At the end of the audit, a final management discussion will occur to identify the strengths and weaknesses of the system. A final report will identify major and minor noncompliance, as well as recommendations for improvement.

RQMIS provides audits of quality systems including complete management of the internal audit program, and can also train internal personnel on auditing processes. We can perform the following types of audits for your organization:

  • Internal Audit based on a schedule or cadence
  • Supplier Auditing
  • Compliance Audits
  • External Auditing on your behalf for due diligence and gap assessment development for new business arrangements

We're also happy to be your audit representative during FDA Inspection Audits, Notified Body Audits, and Customer Audits.

Not sure what type of audit you need?

We can help you with that. Give us a call today at (978) 358-7307, or just click here:

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