- ISO Standards Consulting
- Procedure and SOP Development
- Corrective and Preventive Actions (CAPA)
- Software and Quality Tool Validation
- Supplier Management and Scorecards
- R&D and Design of Experiments (DOE) Support
- Regulatory Compliance and Certification
- Quality Training and Workshops
- Process Optimization and Lean Initiatives
- Risk Management (PFMEA & DFMEA)
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Regulatory Compliance and Certification
We guide businesses through regulatory frameworks to achieve and maintain certifications such as FDA, MDSAP, and CE Marking. Our services include compliance roadmaps, documentation preparation, and internal audits that help you avoid penalties, pass inspections, and meet global market requirements with confidence.
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INFORMATION QUESTIONS
FREQUENTLY ASKED QUESTIONS
What services does MRQC offer?
MRQC provides comprehensive quality consulting services, including ISO 9001, ISO 13485, and IATF 16949 implementation, internal and supplier auditing, CAPA management, SOP and process documentation, and employee training. We also help organizations streamline their processes through Lean Six Sigma and continuous improvement initiatives.
How can MRQC help my company get ISO certified?
We guide you step-by-step—from gap assessment to full certification. MRQC helps you establish or improve your Quality Management System (QMS), write and align procedures, train your team, and prepare for certification audits by bodies such as Intertek, TÜV, or SGS.
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What industries does MRQC specialize in?
Our expertise covers manufacturing, medical devices, automotive, and fabrication industries. With 20+ years of experience in quality leadership, we understand the practical challenges and compliance standards unique to each field.
Do you provide on-site and remote consulting?
Yes. MRQC offers both on-site consulting for hands-on projects and remote consulting via video sessions for documentation review, audits, and training—depending on your company’s location and project requirements.
How long does it take to achieve ISO 9001 certification?
Typically, implementation and certification can take 3 to 6 months, depending on your company’s readiness, size, and complexity. We help accelerate the process by focusing on practical, value-added solutions rather than unnecessary paperwork.
What makes MRQC different from other consultants?
Unlike general consulting firms, MRQC combines hands-on manufacturing experience with deep ISO and regulatory expertise. We don’t just prepare documents—we build systems that improve quality, reduce waste, and enhance productivity. Our goal is not only to pass audits but to create lasting improvement in your organization.
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