RJA Consulting

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Our Credentials

Our Credentials

ISO 9001 Quality Management Standards Exemplar Global Lead Auditor Certification

ISO 13485 Medical Device Standards Exemplar Global Lead Auditor Certification

ISO/IEC 27001 Information Security Management Systems and 27701 Privacy Information Management Education and Experience

EU Medical Device Regulation (MDR) Education and Experience

Medical Device Single Audit Program (MDSAP) Education & Experience

Fellow in the American College of Healthcare Executives

Fellow in the Health Information Management Systems Society

Senior in the American Society of Quality

Involvement with small to large sized organizations and systems Experience in performing internal audits, supplier audits and other accreditation/survey preparation Process Improvement, quality, accreditation, risk management & operations backgrounds

Our Experience

  • Completion of more than 500 audit days for over 375 different clients for the past 5 years.

  •  ISO QMS IAF Scope Categories encompassing textiles, paper products, printing, chemicals, rubber and plastic products, metals, machinery and equipment, electrical and optical equipment, transport, information technology, engineering services, public administration, education, health and social work.

  •  Medical Device Technical Areas including active and non-active devices, active implantable devices, in vitro diagnostic devices (IVD), sterilization methods, and medical device parts and services.

  • Medical QMS Regulations including FDA 21 CFR 820, European Union Medical Device Regulation (MDR), Canada Medical Device Regulations (SOR/98-282), ISO 13485, and ISO 15378.

  • Experience with a variety of Quality roles including Organizational Quality Leader, Supplier Auditor, Internal Auditor, Certification Body Auditor, Accreditation Body Assessor.