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ISO 9001:2008 Blended Certified Lead Auditor with Medical Device Focus (ISO 13485: 2003 – Exemplar Global Certified)

Course ID BISOLA13
Format Blended


This Certified Lead Auditor course makes extensive use of activities and case studies to help you fully understand the requirements of conducting effective audits to the ISO 13485:2003 standard. This course is presented as a two-part blended learning training class that combine the elements of ISO 13485:2003-specific sessions in a web-based on-line environment, followed with a face-to-face, instructor-led class to develop the skills and competencies required of a QMS Lead auditor.

Course Data

  • CEU Hours: 3.9
  • Length: 39 Hours
  • ASQ RU: 3.9
  • Audience: Practitioner
  • Provider: ASQ - ILT
Course Overview

Learning Objectives:

  • Interpret the ISO 9001 and ISO 13485: 2003 specific requirements
  • Understand how to analyze audit results
  • Learn how to evaluate management system documentation.
  • Learn the requirements for auditor certification.
  • Fully understand the roles and responsibilities of audit participants.
  • Know how to tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview
  • Know how to plan and conduct effective audits
  • Know how to manage the audit process, including opening meetings, auditing, closing meetings, and reporting

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).

Who Should Attend:


All individuals who want to become Exemplar Global-certified lead auditors and those assisting their organizations toward ISO 13485 registration, particularly in manufacturing and service organizations. This course will benefit quality directors, managers, engineers, auditors, ISO coordinators, directors of international ventures, laboratory quality professionals, and anyone responsible for leading an audit.

Outline

Part 1 – Web-based

  1. Introduction
  2. Terminology and definitions
  3. Background, history and rationale of quality management
  4. Introduction to ISO 9001:2008
  5. The contents of ISO 9001:2008
  6. Analyzing audit findings
  7. Exemplar Global National Certification Program
  8. QMS Auditor Qualifications
  9. Roles and responsibilities in auditing
  10. The audit checklist
  11. Documentation in the quality management system

Part 2 - Instructor-led classroom Planning and conducting audits

  1. Planning and conducting audits
    1. Applicability of the elements
    2. Audit demonstrations and critique
  2. The closing meetings and the audit report
    1. Preparing for audit #2
    2. Conducting audit #2
    3. Summarizing audit findings
    4. Preparation for a closing meetings
  3. Completing the Audit Cycle
  4. Question and answer review
  5. Exam
Details

Detailed Course Description

This Exemplar Global-certified course is presented by AQS Management Systems Inc. (an Exemplar Global-certified course provider) and QualityWBT Center for Education in association with ASQ. This course is certified in the Exemplar Global Certification Program, and meets the training portion of the requirements for certification of individual quality systems provisional auditors, quality systems auditors, and quality systems lead auditors.
This two-part blended media course makes extensive use of student learning, activities, and case studies to help learners fully understand the requirements of auditing to the ISO 9001:2008 standard. Participants learn the specifics of the ISO 9001:2008 standard and of becoming an auditor, and are provided the time to practice their newly acquired skills in real-life audit situations that assure that students are prepared to conduct effective audits.

Part 1 of this course is delivered by QualityWBT Center for Education in a Web-based (online), self-paced format. This 20-hour course focuses on ISO 9001 requirements, how to interpret the ISO 9001 standard, applying ISO 9001 to a work situation, and/or obtaining Exemplar Global QMS Auditor training. Part 1 provides online access to ISO 9001:2008 standards and access to more than 20 downloadable handouts including an ISO 9001:2008 checklist, a student textbook, study tips, a before-class assessment, and after-class objectives.

During Part 1, learners must submit an assignment for grading as part of the class. Part 1 also consists of eight online tests, an online assignment, and a final test. The online tests are open notes and students are given ample time to answer the questions. Learners have a 90-day subscription access for the online portion of the class.

After successful completion of the online Part 1 session, students have one year to successfully complete Part 2, which is two days of face-to-face, instructor-led classroom training. Upon successful completion of both parts (1 and 2), a certificate of successful completion will be issued. Both parts must be successfully completed to meet Exemplar Global requirements for QMS auditors. Your registration fee covers the entire class (both Part 1 and Part 2).

Format

This course is presented as a two-part blended learning training class that combines the elements of ISO 9001:2008-specific sessions in a 20-hour Web-based (online) learning environment followed with a two-day, face-to-face, instructor-led class to develop the skills and competencies required of a QMA lead auditor.

Materials

Part I provides online access to ISO 9001:2008 standards and access to more than 20 downloadable handouts including an ISO 9001:2008 checklist, a student textbook, study tips, a before-class assessment, and after-class objectives.

Part 2 provides a student manual and handouts.

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

  • Computer – PC or Macintosh
  • High-speed internet connection
  • Adobe Flash Player 10.3 or later
  • Windows: Internet Explorer 8 or later, Google Chrome (latest version), Firefox (latest version)
  • Mac: Safari 7 or later, Google Chrome (latest version), Firefox (latest version)
  • For instructor-led virtual WebEx courses, a speakerphone or telephone headset in a designated room or space with no distractions (preferred)

NOTE: Refer to product description for any additional system requirements.

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 received at least 5 business days before the start of the course receive a full refund/transfer.
    • Requests received within 5 business days of the course starting incur a $150 processing fee.
    • After the course starts, there are no refunds or transfers.
    • Registrants who fail to attend without advance notice are liable for the entire course fee.
    • If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.
  • You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.
Instructors

Enrollment Details

Format: Classroom
Format: Blended

Courses including a combination of media types. Typically, blended learning refers to a combination of classroom-based training with self-paced web-based training modules, or a combination of classroom-based and virtual course instruction.

No Offerings Scheduled English List: $1399 Member: $1299

GROUP TRAINING


ON-SITE TRAINING FOR YOUR ORGANIZATION.


ASQ’s customized on-site training programs are the cost-effective way for you to train employees on your schedule. Training on-site minimizes the cost-per-student, reduces travel expenses, and ensures that the content is specific to your exact needs.

5 Benefits of On-Site Training

  1. Expertise to your location: Saves time and travel expenses
  2. Convenient scheduling: Train groups of five or more
  3. Customizable courses: Training tailored to your groups’ needs
  4. Immediate results: Employees complete courses ready to apply what they’ve learned
  5. Value-add support: Instructors available to answer questions after session