Learn the requirements of the standard in our ISO 13485 Lead Auditor Training while understanding how they relate to your organization.

This class addresses how quality management systems (QMS) and ISO 13485 apply to the medical device industry and how to develop a management system in conformity for ISO 13485 certification.

This ISO 13485 Lead Auditor Training is intended particularly for companies that produce or service medical devices or are part of an FDA regulated industry. It addresses the concerns specific to the medical device industry including risk management, software validation and supplier management.

  • Interpret and apply the requirements of ISO 13485:2016
  • Apply ISO 14971:2007
  • Use the QMS and ISO 13485 to ensure compliance to applicable regulations
  • Implement regulatory issues with minimal impact upon operations
  • Identify and implement the controls necessary for ensuring the QMS consistently meets requirements
  • Develop reliable and pliable systems, particularly effective for organizations where process objectives are constantly changing
  • Determine and communicate the resources necessary for the system to work as planned
  • Communicate the roles and responsibilities within the QMS to the organization
  • Conduct and lead 1st, 2nd and 3rd party audits, particularly on undocumented systems and audit for process effectiveness against measurable objectives
  • Relate the capabilities of the organization to the expectations of customers, top management and shareholders
  • Use the QMS to work proactively and not reactively, manage risk, validate software and manage suppliers
  • Medical device professionals
  • Professionals from FDA regulated industries
  • Quality professionals
  • Individuals who want to become Exemplar Global (RABQSA) certified lead auditors
  • ISO Managers/Management Reps
  • Auditors (internal, 3rd party, and supplier)
  • Process owners
  • Systems professionals or people who want to understand how management systems work
  • Improvement Specialists
  • Buyers in FDA regulated industries
  • Leaders/managers/professionals in the Medical Device industr

This class may be run in conjunction with a ISO 13485 Lead Auditor Training Course.

DAY 1

  • Lecture: Intro to Management Systems
  • Lecture: Quality Standards Including 13485
  • Workshop: Terms and Definitions ISO 19011
  • Lecture: ISO 13485
  • Workshop: Analyzing Processes

DAY 4

  • Workshop: Writing Nonconformity Statements
  • Workshop: ISO 13485–Interviewing Auditees
  • Workshop: Closing Meeting Preparation
  • Lecture: Corrective Action and Follow Up
  • Workshop: Corrective Action
  • Lecture: Certification, Registration, Accreditation

DAY 2

  • Exam: ISO 13485 Self Study
  • Workshop: ISO 13485 Clauses
  • Lecture: Auditing Management Systems
  • Lecture: Developing Process-Based Management Systems
  • Lecture: Audit Planning and Preparation
  • Exam: MD TPECS Exam

DAY 3

  • Workshop: ISO 13485–Review System Docs and Prep Audit Schedule
  • Workshop: ISO 13485–Reviewing Processes and Prep Checklists
  • Lecture: Performing Lead Audit Investigation
  • Workshop: Verifying Facts
  • Lecture: Concluding the Audit
  • Workshop: ISO 13485–Determining Nonconformities

Students successfully completing QMII’s 4-day ISO 13485 Lead Auditor training course and the TPECS examinations provided in conjunction with this course, receive a Certificate of Attainment for the following Exemplar Global (formerly RABQSA International) knowledge competency units:

MD – Medical Devices Management Systems

AU – Management Systems Auditing

TL – Leading Management Systems Audit Teams

The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global in the competency units required for certification as a Medical Devices Management Systems Lead Auditor using ISO 13485:2016.

Successful course candidates can use these certifications as earned credit towards other certifications such as ISO 14001 Auditor and other similar standards under Exemplar Global’s Training Provider & Examiner Certification Scheme (TPECS).