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Good People Working on Good Projects with Good Process

Case Study 1: Quality Management System (QMS)

Situation Client needed QMS oversight to support overall improvements and upcoming audits.
Frestedt Approach
  • Used combination on-site and virtual support methods
  • On-site for all audits, team meetings and training sessions
  • Completed pre-audit paperwork, preparations and identified potential audit findings
  • Created an action plan
  • Developed an improved QMS (document revisions compliant with regulations)
  • Updated the approval process and conducted interactive trainings
Results Frestedt Inc. developed the QMS to reflect current working practices to meet the regulatory requirements and customer needs. Frestedt team developed 2 quality manuals, 20 SOPs, 5 detailed work instructions and more than 30 templates, forms and checklists and conducted an internal audit as well as an external vendor audit for the client and facilitated more than 8 external client assessments / audits in a 6 month period.