Practical QMS (PQMS)

Founded in 2015, in Northeast Ohio, Practical QMS (PQMS) is a certified minority-owned (MBE), and woman-owned (WBE) Quality & Regulatory Consulting Firm. We provide Quality & Regulatory, Process Improvement, Engineering, IT, Project Management, and Staffing solutions for Manufacturers, Government Agencies, Hospitals, Financial, Hospitality, and Education Industries. Our Services Include: Lean 5S now 6S ISO Audit Readiness Training QMS to ISO Standard Gap Analysis ISO 9001:2015 - Lead Auditor, Training and Implementation ISO 13485:2016 - Lead Auditor, Training and Implementation FDA 21 CFR 820 - U.S. Medical Device Regulation Audit Readiness FDA 483 Mitigation cGMP Training (Company-Wide) Global Medical Device Single Point Audit Program (MDSAP) Lead Auditor and Implementation European Union Medical Device Regulation (EU-MDR 2017/745) Lead Auditor and Implementation ANVISA RDC 665-2022 Brazil GMP for Medical Devices CMDR SOR 98-222 Canadian Medical Device Regulation TGA - Australia Medical Device Regulation AS9100 Rev D - Aerospace Industry Audit Readiness, Training and Implementation IATF 16949 - Automotive Industry Audit Readiness, Training, and Implementation QMS Documentation Clean-Up and Alignment to Standards and Regulations HW and SW Design Verification/Validation Change Management Process Implementation Customer Complaint Handling Mitigation Corrective and Preventive Actions Mitigation Risk Management Process Implementation Root Cause Investigations Supplier Audits and Qualification Supplier Corrective Action Mitigation Lean Six Sigma Organization-Wide Team Building Activities (All Industries) And more. Partner with PQMS today to experience unmatched business success and growth.