Comprehensive Internal Audits and Quality Management Systems

At ISO-AID LLC, we pride ourselves on delivering top-notch services designed to refine and enhance your operational excellence through comprehensive internal audits, gap analysis, and quality management system implementation.

Quality Management System Expertise

Boost your compliance and performance with our comprehensive guidance across various standards, including:

  • ISO 9001 Quality Management System (QMS)
  • ISO 13485 Medical Devices
  • European Medical Device Regulation (MDR) 2017 245
  • European In vitro Diagnostic Medical Devices (IVDR) 2017 246
  • GMP Finished Pharmaceuticals, 21 CFR 210 and 211
  • MDSAP for Australia, Brazil, Canada, Japan, and US FDA
  • FDA QMSR alignment with ISO 13485; FDA 21 CFR 820
  • AS9100; AS9120; and AS9110 Aerospace

    • Our auditor-certified professionals, backed by solid records of certification and experience, are ready to conduct audits onsite, remotely, or through a hybrid approach.

    Internal Audits

    We schedule our comprehensive internal audits to align with your unique needs, considering the number of employees, processes, and regulatory requirements. Expect a detailed audit report summarizing findings for actionable insights, delivered promptly within one week of audit completion.

    Quality Management System Implementation

    Navigate the complexities of QMS documentation with our expert assistance. From addressing third-party audit actions to achieving your quality objectives, we ensure your quality management systems comply with the pertinent standards and regulations.

    Gap Analysis

    Our gap analysis service goes beyond the surface to deliver a full-system process audit. You'll receive a comprehensive report detailing findings without the pressure of documented corrective action, delivered swiftly within one week post-audit.

    Documentation Assistance

    Leverage our expertise in creating a robust document and record control system. We cover all aspects of documentation, from identification to disposal, complemented by custom flowcharts and data analytics to clarify the process flow further.

    Regulatory Compliance

    Stay ahead of the curve with our guidance on QMS regulatory requirements, including FDA (21 CFR Part 820), FDA QSMR, EU MDR Medical Device Regulation, IVDR, and Finished Pharmaceuticals (FDA 21 CFR Part 210 and 211).

    Comprehensive Report Types

    Our tailored report types reflect our commitment to detail and quality, ensuring your quality management systems are beyond reproach. The following are our report types:

  • Clinical Evaluation Report
  • Clinical Performance Report
  • Post-Market Surveillance Plan
  • Post Market Surveillance Report
  • Summary Report

    • Trust ISO-AID LLC to empower your business with our unmatched comprehensive internal audits and quality management system services, steering you towards operational distinction and regulatory compliance. Get in touch to learn more.