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QMS Design & Management

Your Quality Management System (QMS) defines how you develop, manufacture, and distribute your product. Depending on your product classification, regulations will impact the design of your quality system. Our team of consultants can design a custom quality system around achieving your business objectives, while also adhering to the necessary regulations. We cover the whole spectrum, ranging from providing templates you can use to create your own custom quality system to designing an entire quality system for your company from the ground up.

No matter how well your quality system is designed, it is nothing without compliance. Periodic checks (audits) of your quality system effectiveness are critical. Audits confirm that your company is following the proper procedures, but more importantly, an audit should confirm that your procedures are effective and efficient in achieving your intended operational objectives.

Unfortunately, sometimes audits don't go the way we plan. If you find yourself on the receiving end of an FDA Form 483, a Warning Letter, or significant noncompliance during an ISO audit, we can assist you in designing corrective action plans and then negotiate these plans with the proper government representatives as necessary.

We also provide a full range of auditing services for your QMS including complete management of the internal audit program. We also offer comprehensive training courses to train your internal staff so that they can perform future audits for your organization.

Audit Services

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

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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