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RQMIS
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QMS Design & Management

Your Quality Management System (QMS) is the foundation of how you develop, manufacture, and distribute your product.

The design of your QMS is shaped by your product classification and the regulations governing it. At RQMIS, our expert consultants specialize in creating custom QMS solutions that not only align with your business objectives but also ensure full regulatory compliance.

We offer a flexible range of services, from providing ready-to-use templates for building your QMS to designing a comprehensive, fully customized system from the ground up.

However, even the most meticulously designed QMS is only as strong as its compliance. Regular audits are essential to verify that your organization is adhering to established procedures and, more importantly, to ensure those procedures are both effective and efficient in achieving your operational goals.

Let us help you build and maintain a QMS that drives quality, compliance, and success.

Success Story

Medical Device Redesign Reduces Product Delays

Audits don’t always go as planned—but RQMIS is here to help you navigate those challenges.

If your organization receives an FDA Form 483, a Warning Letter, or faces significant noncompliance findings during an ISO audit, our team can step in to design effective corrective action plans. We’ll also work with the appropriate regulatory authorities to negotiate and implement these plans efficiently.

In addition to corrective actions, RQMIS offers a comprehensive suite of auditing services to ensure your Quality Management System (QMS) remains effective and compliant:

  • Supplier Audits
  • Internal Audits
  • Compliance Audits
  • Internal Auditor Training

We can fully manage your internal audit program or train your team to independently conduct future audits with confidence.

Partner with us to ensure your QMS stands up to scrutiny and supports your organization’s long-term success.

Success Story

Successful FDA CAPA Manufacturing Inspection

Your Quality Management System (QMS) serves as the blueprint for how you develop, manufacture, and distribute your product.

The design of your QMS is influenced by your product classification and the specific regulations governing it.

At RQMIS, we specialize in creating custom quality systems that align with both regulatory requirements and your business objectives. Whether you need ready-to-use templates to build your QMS internally or require a fully customized system designed from the ground up, our team is equipped to support your needs.

Let us help you build a QMS that ensures compliance, efficiency, and long-term success.

Want to explore what QMS design and management looks like in your organization?

Our experts are ready to talk it out. Call us today at (978) 358-7307, or just click here:

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