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ISO 13485:2016 Certified Lead Auditor Training

Course ID VISO134852016CLA
Format Live Virtual

Prepare yourself for real-life ISO 13485:2016 auditing situations and learn how to manage the complete audit process.

This course is Exemplar Global-certified.


Understand the requirements of ISO 13485:2016 to be able to conduct a successful audit. Learn how it compares to 21 CFR 820 and ISO 9001:2015. Conduct practical audit exercises to apply these requirements and manage the audit process in a collaborative and engaging environment.

This virtual, instructor-led course is comprised of three successive components delivered in convenient, 4-hour sessions spread over 2 weeks, or 8-hour sessions spread over 4 consecutive days. 
Foundations
Certified Internal Auditor – Management Systems Auditing
Certified Lead Auditor – Leading Management Systems Audit Teams

Important: Once enrolled, please note that you will see an icon representing each component in ASQ’s learning platform.

ASQ virtual courses provide electronic access to course materials for 90 days beginning five days before the first day of your course.  Extensions and/or refunds cannot be issued if course materials have been accessed.  Chrome and Edge browsers are recommended – Internet Explorer is not supported. 

Note: For the exam portion of the course, each attendee is required to have a computer with a webcam (smart phone can be used if computer webcam is not functional). Paper exams available with prior notice for onsite virtual courses only.

Course Data

  • CEU Hours: 0
  • Length: 36 Hours
  • ASQ RU: 3.6
  • Audience: Practitioner, Professional
Course Overview

Learning Objectives:

  • Fully 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 and the ISO 13485 Standards during 5 practical audit exercises conducted during the class
  • Understand the terminology of the ISO 9001 and ISO 13485 and how these apply in a Medical Device Environment
  • Learn how to develop an ISO 9001 / 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

Prerequisites:

All attendees are required to have their own copy of the ISO 13485:2016 Standard.

Who Should Attend:

Those responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485, Quality Assurance Managers, Quality Assurance Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory Personnel or anyone desiring an in-depth understanding of the ISO 13485 Audit Process. This course has been specifically designed to meet the needs of the Medical Device Industry
Outline
  1. Course Introduction
  2. Terminology and Definitions
  3. Background, History and Rationale of Quality Management
  4. Introduction to Documents and Resources
  5. Analysis of the Requirements of the Standard
  6. Audits and Audit Findings
  7. Exemplar Global & ANAB
  8. Auditor Qualifications
  9. Roles and Responsibilities During Audits
  10. The Audit Checklist
  11. Documentation in the Management System
  12. Planning and Conducting Audits
  13. Application of the Audit Cycle
Details

Format

An Internet-based, instructor led course utilizing web and teleconferencing technologies to allow students to interact without traveling.  Virtual courses offer interaction with instructor and students via phone and Internet capabilities. Students have access to interaction both with the instructor and other students in an Internet-based learning environment (white board, Q&A tools, application sharing, and breakout rooms).  Virtual courses are classroom-like experiences offered using the latest Internet tools. 
System Requirements
Here is what you need to participate in an ASQ web-based, self-paced, or instructor-led virtual WebEx course.

Registration Email

After course registration, you will receive an email with access instructions. If you do not, please check your email junk, spam, or clutter folders. If the email is not there, please contact ASQ. For virtual WebEx courses, you will receive another email 24 hours prior to the start of class containing additional access information.

Technical Requirements (impacts all ASQ-owned eLearning)

Hardware

  • PC, Mac, or mobile device
  • Audio speakers or headset
  • High-speed internet connection

Browsers for ASQ Courses

You can view courses on any devices that support these browsers. This includes mobile devices such as iPhones, iPads, and Android-enabled phones and tablets.

  • Windows: Internet Explorer 11, Microsoft Edge (latest version), Google Chrome (latest version), Firefox (latest version)
  • Mac: Safari (latest version), Google Chrome (latest version), Firefox (latest version)
  • Mobile: Safari in Apple iOS 10 or later, Google Chrome in Apple iOS 10 or later, Google Chrome in Android OS 4.4 or later

Required Browser Settings for Viewing Courses

  • JavaScript must be enabled for published courses to work.
  • Font downloads must be enabled to see the correct fonts and characters.
  • When using Internet Explorer, turn off Compatibility View for sites where courses are hosted.

WebEx – Virtual Course: Advance Preparation and Student Information

Join a Test Session

We strongly suggest that you join a WebEx test session in advance of your scheduled virtual training, using your preferred web browser. This can help prevent problems launching content the day your training begins.

If you do not have administrative privileges on the SAME computer you will be using the day of your training (i.e., your workstation within your organization) you may need the assistance of your local IT/IS help desk staff for the platform to engage correctly.

To join a test session (meeting), click here and enter your name and email address to join. If successful, you will see a screen that says "Congratulations! Your system is now set up properly ..."

Deactivate Pop-up Blockers

You should deactivate any pop-up blockers, spam filters, and company firewalls that could prevent the WebEx client platform or web-based course from working properly. Third-party toolbars such as Bing, Yahoo, and Google should also be disabled due to their own pop-up blocking capabilities.

Cancellation Policy
 ASQ reserves the right to cancel or re-schedule courses and to change instructors. Please be advised that in the event of a course cancellation, ASQ is not responsible for airfare penalties or other travel related expenses you may incur.

If you need to cancel, we will refund your paid registration fee as noted below.

Requests for cancellations/transfers/substitutions received at least 30 calendar days before the start of the course can receive a full refund/transfer/substitution. 
There are no refunds within 30 calendar days before the start of the course. 
Requests to transfer or substitute received between 29 and 10 calendar days of the course starting incur a $150 processing fee.
There are no transfers within 9 calendar days before the start of the course.  Substitutes may be accepted if content has not been accessed by original registrant.  Substitutions will incur a $150 processing fee.  
There are no refunds or substitutes if the content has been accessed. 
Enrolled students who fail to attend their registered course without advance notice are liable for the entire course fee. Substitutes will not be accepted after the course has begun. 
You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.
 

Enrollment Details

Format: Classroom
Format: Live Virtual

A web-based, live, classroom-like instructor led experience allowing attendees to interact without traveling. Course includes online access to materials for a limited time and up to three hard copy prints. Some courses include an electronic book – see course description for details.

March 13, 2023 - March 16, 2023 08:00 AM - 06:00 PM CST This class is filled to capacity. Check back for future offerings. Show Class Schedule VIR1080 AQS Solutions English Early Bird Ends February 11, 2023 List: $1575.00     Member: $1475.00 Regular List: $1905     Member: $1735

Attendance to all virtual sessions is required to earn a certificate of completion and for the course to be listed as completed on your ASQ transcript.

Schedule: (4 days)
March 13-16, 2023

 

*Times: 8:00 AM - 6:00 PM (Central Time Zone). Includes approximately 1-hour for Lunch and Breaks throughout the day.

 (Virtual sessions are NOT recorded)

 

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