Quality Assurance Consulting

Altemir Consulting can establish practical non-conformance and corrective/preventative action (CAPA) protocols that effectively feed back into the engineering and production processes to continually improve product quality.  We have direct experience in ISO 9001, FAR, ISO 13485, and FDA cGMP environments including audit support and certification preparedness.  We can also help establish your initial Quality Management System.

Facets of your quality assurance regime that we can address include:

  • Non-conformance reporting
  • ISO quality management system implementation
  • ISO document development and audit support
  • Inspection requirements and planning
  • Engineering product requirements
  • Process verification  and validation
  • Regulatory compliance reporting
  • Document control
  • QMS IT system selection, implementation, and support
  • Training requirements and recordkeeping
  • Engineering change management
  • Supplier quality
  • Quality scorecards

Explore the Possibilities...

We welcome inquiries from all businesses, small and large, that are eager to move to the next level.  Feel free to contact us to discuss your specific needs at no obligation.