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Quality System Design and Compliance

Are all of your processes and procedures for the manufacture of your product documented? Are all personnel aware of and consistently following your procedures?

Your quality system (QS) defines how you develop, manufacture, and distribute your product. Depending on your product classification, regulations will impact the design of your quality system.

RQMIS can provide a custom quality system based on appropriate regulations that achieves your business objectives. Our support ranges from providing templates you can use to create your own custom quality system to designing an entire quality system from the ground up.

However, a quality system is nothing without compliance. Periodic checks (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 and efficient in achieving your intended operational objectives.

If you find yourself on the receiving end of a FDA Form 483, a Warning Letter, or significant noncompliance during an ISO audit, RQMIS can assist you in designing corrective action plans and negotiate these plans with the governmental body or Notified Body.

RQMIS provides audits of quality systems including complete management of the internal audit program. We can also train personnel you designate as auditors:

  • Supplier audits
  • Internal audits
  • Compliance audits
  • Internal auditor training

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