FDA Warning Letter Response and QMS Transformation


"We called Rath & Strong after we received an FDA Form 483 warning letter. Their consultants came in and bolstered our efforts to pinpoint and fix our issues."
– Astra Zeneca

"FDA was happy to hear that Rath & Strong was chosen to provide consulting and implementation support for a remediation plan to restore compliance."
– Pfizer

What is a Quality Management System (QMS)?

A QMS is the organizational structure, procedures, processes and resources needed to implement quality planning, quality control, quality assurance and quality improvement. An effective QMS is focused not only on the results, but also the means to achieving these results.

The four essential elements of a QMS are:

  • PLAN - Policy and Objectives Providing Guidance to the Organization
  • CONTROL - Defined Responsibilities So People Know Clearly What Is Expected
  • ASSURE - Defined Processes Linking Daily Activities to the Objectives
  • IMPROVE - Continual Improvement of Process Performance
Standards are not a QMS.

ISO 9001 and other similar standards are not a QMS. However, they provide a guide for developing an organization's QMS. These standards contain accepted good management practices for meeting stakeholder requirements. Therefore, there are several benefits to ensuring your system conforms to a standard, including:

  • Incorporating lessons learned from a multitudes of organizations
  • Common language across the organization and the value chain
  • Legal protection, showing compliance to accepted good management practices
  • System certification, making it possible to do business where compliance is required
We believe the implementation of a Quality Standard should ensure that your company realizes the full business benefit of a Quality Management System, avoiding the trap of it being seen as certification for its own sake.

Our Approach

We enhance the methods you use to run your business while at the same time conforming to any applicable standards and regulations, such as ISO. We ensure improved organization buy-in as well as lower implementation costs. We work closely with our clients to manage projects and ensure objectives are achieved. Also, your new QMS will be self-improving using your Lean Labs, Agile, Transformation or Lean Six Sigma tools and methods. And of course, we will pass on our skills to your people so that you have a system that is truly self-sufficient.

Our Services
  • FDA Form 483 Warning Letter response and corrective program implementation
  • Assessment to identify the strengths and gaps in your current system
  • Consultation to design and implement your QMS
  • Develop and implement Lean Labs initiatives
  • Training and coaching to manage implementation
  • Change management training and coaching
  • Support creating and maintaining documentation
  • Training and consultation for continuous improvement

To learn more about these and other Quality Management services, please complete our inquiry form