QMS Audits and Inspections

How RQM+ Delivers Value

RQM+ acts as a strategic partner and an extension of your business when conducting audits. We provide business value with a dedicated team of seasoned, certified ISO 13485 and biomedical auditors. Whether you engage us for individual audits, remediation strategies, or fully outsourced audit programs, your organizational goals are our goals. This allows us to deliver transformative solutions that balance regulatory risk with your business objectives and provide strategic direction on preparing your quality management system to meet evolving regulations and standards.

A Proactive Approach to Audits and Inspections

When possible, we recommend proactively preparing for the inevitable audit or inspection. You know it’s coming, so why not delight inspectors with your readiness and reduce the burden on everybody? This can be a difficult undertaking, especially when your internal teams are managing multiple responsibilities.

RQM+ can provide the necessary resources to identify the weaknesses and gaps, create a strategy to fill them, implement the plan, and validate it with a mock audit. The result is not just a comprehensive response to findings, but also improved systems and processes that help you reach business goals. 

Learn more about our quality management system services.

Audit and Inspection Strategy

Whether you have just started implementing new requirements such as MDR, need guidance on creating a quality management system that works for you rather than you working for it, or are preparing for an upcoming external audit, we can be your strategic partner. Many members of our team have been on both sides of audits, so we understand how to balance business needs and regulatory requirements.

For scheduled audits, our team can help you develop a risk-balanced strategy that allows you to invest the appropriate level of resources into preparation. We can also help you maintain a schedule for required internal and supplier audits to help you stay compliant with all regulatory requirements.

When an inspector arrives unannounced, give us a call and we will dispatch an emergency team to guide you through it. Regulators have also started performing simultaneous inspections of multiple sites. When this happens, our scalable team will be right by your side, no matter where your facilities are located. 

	Certified and Seasoned Auditors With specialized training and decades of experience, our certified and seasoned auditors have seen it all. No matter what audit findings and deficiencies arise, we’ll help you through it.
	Global Team Our global team of auditors will support you both remotely and onsite for as long as necessary to guide you through your audit or inspection. We’ll even send our rescue team within hours of an unannounced audit so you don’t have to go it alone.
	Dedicated Audit Teams Internal audit teams rarely have the head count needed, and shared resources from other departments are already overwhelmed with their day jobs. With a dedicated RQM+ audit team, you can outsource specific audits based upon site location, product lines, acquisition, and so on, and apply your internal resources where they are needed the most. Whether you just want to augment your team or have us handle it all, RQM+ has a dedicated team of resources ready to support you.
	Industry insights With former FDA regulators and notified body leadership on staff, in addition to seasoned subject matter experts who have experienced just about every scenario you can think of, we know what inspectors and auditors are expecting and best practices and strategies for responses. Onsite, we have a presence in both the front room and the back room to facilitate communication with all parties involved.

Reacting to an Audit or Inspection

If you receive a 483, warning letter, or notified body nonconformity report, you need a strategy for responding in a way that supports your business and keeps the doors of communication open. Our seasoned team will help you develop the appropriate response and negotiate with regulators or notified bodies to get your systems compliant in the prescribed time frame.