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ISO 9001 Lead Auditor Training

Exemplar Global Certified Certified Lead Auditor Training Course

Learn how to assess conformance with ISO 9001 from the industry experts. Oriel STAT A MATRIX has been training ISO 9001 lead auditors longer than any other training organization in the world. Our ISO 9001 Exemplar Global-certified lead auditor training course, presented largely through hands-on workshops, teaches you the skills you need to plan, conduct, and follow-up on ISO 9001 compliance audits.

Our ISO 9001 Lead Auditor training is designed for first-, second-, and third-party auditors and professionals leading corporate ISO 9001 compliance activities. This course is perfect if you are involved with your organization's internal audits and wish to broaden your understanding of the quality management system (QMS) audit process.

The ISO 9001 Lead Auditor training course and the associated examination provide the necessary body of knowledge and assessment techniques to cover the requirements for registration, when combined with appropriate documentation of education, professional experience, and auditor practice. Certified in the US by Exemplar Global, this course meets the training portion of the requirements for certification of individual Quality System Provisional Auditors, Auditors, and Lead Auditor and meets the requirements for QMS Senior Auditor training.

Exemplar Global requires that all attendees study the current published version of ISO 9001 before attending the class. 

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Course Detail

Objectives

You will learn the background on the ISO 9000 standards and go through every phase of the audit so you are ready to lead your own audits.

  • QA System Assessment: Use our proactive approach to quality assurance, understanding the elements that comprise a total quality system (policy, manual, procedures, and instructions).
  • The Requirements: Understand the relationships among the ISO standards and the specific requirements of ISO 9001:2015.
  • The Audit Cycle: Using ISO 19011, with practical hands-on workshops, you are introduced to audit functions: preaudit activities, conducting the audit, and postaudit activities.
  • Preaudit Activities: Through dynamic workshops, learn how to plan audit activities, develop checklists, perform preassessment visits, and conduct opening meetings.
  • The Audit (Assessment): Hands-on workshops demonstrate how to collect objective evidence, including active listening and questioning techniques, and methods to handle confrontations.
  • Postaudit and Follow-Up Activities: Understand 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
  • Auditor registration
  • Interpretation of ISO 9001:2015
  • Quality system documentation
  • 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
  • Follow-up and corrective action
  • Final examination (2 hours)

Workshops Include:

  • Documentation audit of a quality manual and procedures vs. ISO 9001:2015
  • Auditor interpretation of ISO 9001:2015
  • Preparing and performing opening and closing meetings
  • Developing checklists
  • Active listening and questioning techniques
  • Simulated audit case study
  • Preparing nonconformity reports and the final report

 

Who Should Attend

Designed for third-party auditors, and professionals leading corporate ISO 9001 compliance activities. Perfect if you are involved with your organization's internal auditing process and wish to broaden your understanding of the total audit process. Recommended for anyone heavily involved in supplier quality assurance (SQA) activities. While it is suggested that you have some knowledge of ISO 9001 or similar quality management systems, there is no formal prerequisite.

  • Virtual Half-Days

    9
  • In-Person Full-Days

    5
  • CEUs

    4.4

Virtual Session Details

Virtual Session Details

The learning objectives and topics covered during VILT are the same as those for the in-person version of the course. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment.  Each VILT session is a combination of subject matter expert and group discussions, interactive whiteboards, polls, and chat rooms that help students with small group exercises, making this an engaging, interactive learning experience.

Online Training Schedule

  • This class is delivered across 9 consecutive business days.
  • The first 8 days run daily 1:00 - 5:00 p.m. Eastern time; the final session runs 11:30 a.m. - 5:00 p.m. ET to allow time for administering the final exam.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

See course dates to find / register for a virtual online session of this course.

Virtual Session Details

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Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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