4-Day ISO 13485:2016 Lead Auditor with 21 CFR 820 – $1995 Recognized by Exemplar Global

Quality Medical Device Management Systems Lead Auditor with ISO 13485:2016 and FDA 21 CFR 820

We teach you how to use auditing to improve your organization

 Days: 4 • CTUs: 3.6 • Price: $1995

Monday-Thursday  8:00 am – 6:00 pm

Each 4-day class covers:

  • Quality management principles
  • Standards and guidelines (including history of standards)
  • Interpretation of the latest revision ISO 9001
  • Interpretation of the latest revision ISO 13485
  • FDA 21 CFR 820
  • Documentation and records
  • Introduction to quality audit
  • Managing the audit process
  • Audit scheduling and preparation
  • Performing the audit
  • Reporting the audit
  • Corrective action and follow-up
  • Registration, Accreditation and Auditor Certification

The Workshops include:

  • Analyzing Processes to Identify Resources and Critical Controls
  • Analyzing Operational Risk
  • Reviewing System Documentation and Preparing an Audit Plan
  • Reviewing Processes and Preparing Checklists
  • Verifying Facts
  • Determining Nonconformities
  • Writing Nonconformity Statements
  • Interviewing Auditees
  • Chairing a Closing Meeting
  • Reporting the Audit
  • Taking Corrective Action


Attendees successfully completing the examinations provided in conjunction with this course receive a Certificate of Attainment for these EXEMPLAR GLOBAL knowledge competency units:

MD – Medical Device Management Systems
AU – Auditing Management Systems
TL – Leading Management Systems Audit Teams

The Certificate of Attainment provides evidence of knowledge competency defined by EXEMPLAR GLOBAL for certification as a Medical Device Management Systems Lead Auditor.

Even though ISO 9001 and ISO 13485 are used as the model for teaching systems and audit, this course enables students to develop and apply auditing skills using any applicable management system standard.

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Completion of this course satisfies the training requirements for certification by Exemplar Global as a lead auditor.