ISO 9001:2008 36-Hour Certified Lead Auditor with Medical Device Focus (ISO 13485 – Exemplar Global Certified)

Understand the elements that constitute a quality system, and the audit evidence necessary to comply with ISO 13485 requirements. The course includes hands-on workshops that allow you to replicate the working environment of the medical device industry. The curriculum will reinforce key topics critical to your success in this field.

Omaha, NE (9551ILT)
Schedule and Travel Info Contact Us
October 24 – 28, 2016
This date is not available.
Orlando, FL (9516ILT)
Schedule and Travel Info Contact Us
December 12 – 16, 2016
This date is not available.
On-Site Training
Need to train a group of five or more? Consider on-site training.

This training course is an Exemplar Global-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 and Exemplar Global. With an emphasis on hands-on training, this course features workshops tailored to the working environment of the medical device industry. You will discuss a range of topics including ISO 13485 Medical devices—Quality management systems—Requirements for regulatory purposes, as well as ISO 9001:2008. Workshops reinforce key topics including documentation of audits, opening and closing meetings, auditor interpretations, listening and questioning techniques, checklists, and nonconformance reports.
This course is offered in cooperation with AQS Management Systems, an Exemplar Global Certified course provider and meets the training requirements for individual auditor certification.

  • Learning Objectives
    • Understand and interpret the requirements of ISO 9001:2008 in a Medical Device Environment
    • Understand and interpret the requirements of ISO 13485
    • Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
    • Understand the requirements contained in 21 CFR 820 and be able to compare these to the requirements in ISO 13485
    • Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
    • Understand how to apply the requirements of ISO 9001:2008 and the ISO 13485 Standards during 5 practical audit exercises conducted during the class
    • Understand the terminology of the ISO 9001:2008 and ISO 13485 and how these apply in a Medical Device Environment
    • Learn how to develop an ISO 9001:2008 / ISO 13485 auditing system based on the ISO 19011 auditing requirements
    • Learn how to ask audit questions that get results
    • Learn how to conduct opening and closing meetings that have impact
    • Learn how to construct effective audit checklists
    • Learn how to generate effective corrective actions
  • Who Should Attend


    Professionals involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier QA effort should attend this training.

  • More Information

    Prerequisites

    All attendees are required to bring their own copy of the ISO 13485:2003 standard to this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ (item T13485).

    Course Data

    • CEU Hours: 4.4
    • ASQ RU: 4.4
    • Audience: Advanced
    • Provider: ASQ - ILT
    • Course ID: CLAMD
    • Course Length: 44 hours
    • Cancellation Policy
  • Instructors

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