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Quality Systems & Compliance

Quality Systems = Company Operations = Financial Success?

A company’s Quality System is simply the manner in which they develop, manufacture, and distribute their product/service with the ultimate purpose of satisfying their customers existing or anticipated requirements. How the company defines (standard operating procedures) and implements (employee training and listening to customer feedback) their Quality System will ultimately affect their financial success1.

A Quality System that operates in a regulated environment becomes complicated as a result of interpretation and application of regulations. The regulations that affect a company’s Quality System depends on the product they produce and the markets they sell in. The complexity can range from trivial for products that are exempt of these regulations to complex for a company that produces a combination product (drug/device or biologic/device).

The final variable that has a significant impact on the success of a Quality System is organizational culture. The manner in which company employees are engaged with their Quality System is often a weak link in a company’s success in implementing their Quality System. Common questions we suggest a company ask themselves are:

  • Are company employees working as true team players or are they “siloed” protecting their “turf”?
  • Is executive management engaged with their employees or is there simply a command and control relationship?
  • Is there a true application of risk management within their organization?

 1 Sroufe, Robert and Sime Curkovic, "An examination of ISO 9000:2000 and supply chain quality assurance." Journal of Operations Management, Volume 26, Issue 4, July 2008, Pages 503-520

Tailored Solutions from RQMIS

RQMIS listens to the needs of our clients and provide customized solutions to achieve their business objectives. Our support ranges from providing templates companies can use to customize for their company’s requirements to designing an entire quality system. RQMIS has been retained to and successfully completed the following projects in the past year:

  • Overall management of a company’s internal audit program
  • Manage/negotiate FDA Warning Letters
  • Conduct full Quality System audits for compliance with Medical Device, Pharmaceutical, Biologics and Tissue regulations
  • Design, implement and receive EN/ISO13485 certification on Quality Systems
  • Design process and forms to capture regulatory pathways and decisions to file premarket submission
  • Design reliability-verification protocols for design control activities
  • RQMIS consultants provide both a depth of knowledge and experience that can be customized based upon a client’s needs. Examples of Quality System Consultants and Technical Writers that are available.
  • RQMIS Auditing Programs