Mona Elkhatib has over 15 years of experience in Process Improvements, Quality Management Systems and Assurance, Regulatory Compliance, Training and Auditing.
Areas of Expertise:
Mona’s expertise is in design and development of ISO recognized Quality Management Systems organizations in a manner to fit the organization’s needs and improve the efficiency of their current processes, while maintaining regulatory compliance. She has strong background in ISO 13485 Medical Devices system requirements including regulatory requirements such as FDA QSR, and Health Canada MDR.
Scope of Experience:
Mona has designed, developed and assisted in implementation of ISO recognized Quality Management Systems for over 50 organizations. She has worked in various industry sectors including oil and gas, metal fabrication, electronics, plastics, health care, and medical equipment and diagnostics.
In her role as a Lead Auditor for the accredited registrars, Mona audited over 500 companies from both the manufacturing and service sectors. She trained and witnessed auditors and reviewed the audit packages to issue ISO 13485 certifications to the organizations. In her role as a Trainer, she delivered ISO 9001, ISO 13485 lead auditor classes, on-site (customized) and in a public setting. Finally, in her role as an Advisor she designed and developed ISO 9001 and ISO 13485 compliant management systems for over 50 organizations.
Education and Training:
Mona holds a Master of Science degree in Biomedical Engineering from the University of Texas Southwestern / The University of Texas at Arlington and a Bachelor of Science degree in Industrial Engineering from The University of Texas at Arlington.
Honors, Awards and Special Accomplishments:
Mona is an ASQ Senior Member and is a Certified Quality Auditor (CQA) and Certified HACCP Auditor (CHA). She is an IRCA Certified Lead Auditor for ISO 9001, and ISO 13485 under Canadian Medical Device Conformity Assessment Scheme (CMDCAS) requirements. She has completed the qualification and training requirements for the Medical Device Single Audit Program (MDSAP) sponsored by FDA. She is also qualified for American Petroleum Institute (API) 9th Edition with product specifications including 5CT, 5L, 7-1, 15LR, 15HR and 6A.
Accredited Registrar – SAI Global
TrailBlazer Health Enterprises
Accredited Registrar – Quality Management Institute (QMI)
Productivity Improvement Center
Integrated Management & Information Consultants