At Paul L Clark & Associates, we’ll help you establish a quality management system (QMS) tailored to meet your business needs. As a trained Notified Body ISO13485/MDD Lead Auditor, we offer an inside understanding of the QMS certification process. Our knowledge and experience is based on hundreds of external, internal and supplier audits, and first-hand experience planning and implementing systems for certification to ISO9001/13485/MDD, and compliance to the US Quality System Regulations (21 CFR 820). We have the capabilities to offer a range of QMS services, including:

  • General QMS consulting and training
  • ISO 9001/13485 & QSR/cGMP gap analyses
  • Developing QMS policies/manuals, SOPs, work instructions
  • ISO14971 risk management implementation, mitigation & training
  • Design and development control systems
  • Complaint handling and MDR reporting
  • Internal audits
  • Supplier audits