ISO 13485:2016 Lead Auditor

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.

LEARNING OBJECTIVES

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

WHO NEEDS THIS COURSE?

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.

CLASS AGENDA

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

CERTIFICATION

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).

Download a course brochure