_Auditor/Lead Auditor Training for ISO 13485

Onsite Training & Consulting
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Course Description

Certified QMS Lead Auditor Training Course

Learn how to assess compliance with ISO 13485 and ISO 9001 from the industry experts. Based on our ISO 9001 RABQSA-certified QMS lead auditor training course, this interactive course covers ISO 13485 in addition to ISO 9001 requirements for quality management systems.

NOTE: To attain registration as a QMS Auditor, QMS Senior Auditor, or QMS Lead Auditor, you must pass the written final examination, earn a passing grade in the course continuous assessments, and meet prescribed professional requirements, including a number of actual ISO 13485 audits. This training course is an RABQSA-certified course and meets the training requirements for certification of individual QMS Auditors, QMS Senior Auditors, and QMS Lead Auditors. "Successful completion" satisfies the training requirements for individual auditor certification by accrediting bodies such as IRCA, RABQSA, JAB, and CRBA.

This Oriel STAT A MATRIX RABQSA-certified course contains mandatory evening sessions.

CEUs:4.4
Number of days:5
Code:LAF
Cost:$1995.00

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Objectives

During five days, you will cover background of the ISO 9000 and ISO 13485 standards, and go through every phase of the audit-from planning to conduct to follow-up so you will be able to lead your own audits efficiently and effectively.

  • QA System Assessment: A proactive approach to quality assurance in the medical device industry; covers elements that comprise a total quality system, including policy, manual, procedures, and instructions.
  • Understanding the Requirements: Discuss the requirements of ISO 9001 and ISO 13485, as well as applicable industry regulations.
  • The Audit Cycle: Using ISO 19011, with practical hands-on workshops, learn about audit functions: preaudit activities; conducting the audit (assessment); postaudit and follow-up activities.
  • Preaudit Activities: Using interactive workshops (syndicated activities), learn to plan audit activities, develop checklists, perform preassessment visits, and conduct opening meetings.
  • Conducting the Audit (Assessment): Use hands-on workshops to learn how to collect objective evidence; covers active listening and questioning techniques, as well as methods to help handle confrontations.
  • Postaudit and Follow-Up Activities: Through workshops and assignments, learn how to conduct closing meetings, write effective audit reports, issue nonconformance forms and corrective action reports, assess corrective action, close out nonconformances, and conduct surveillances.
Topics
  • Overview of auditing
  • Interpretation of ISO 13485
  • Quality system documentation
  • Quality manual and procedures
  • The audit cycle and ISO 19011
  • Preaudit activities: opening meeting and checklists
  • Auditing practices; the psychology of auditing
  • Nonconformity reporting
  • Performing the audit
  • Closing meeting
  • Process auditing
  • Report writing
  • Final report
  • Follow-up and corrective action
  • Final examination (2 hours)
Who Should Attend

Although originally designed to train third-party auditors, most participants lead their company’s quality system implementation and/or audit programs. Ideal for anybody involved in a supplier quality assurance program.

Upcoming dates and locations
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To register by phone, call 800.472.6477

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