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ISO 13485:2016 MD Management System Auditor

Learn how to plan, conduct, and assess compliance with ISO 13485:2016 and gain certification of attainment in this comprehensive course. Perfect for auditors and professionals leading compliance activities, as well as those involved in supply chain management or supplier quality control. Expand your knowledge and enhance your skills in medical device management system auditing.

  • Intermediate
  • 18 and older
  • $1,495
  • 28 Lord Road, , Marlborough, MA
  • 27 hours over 3 sessions

Start Dates (0)

  • $1,495
  • QPS @ 28 Lord Road, Ste 205, Marlborough, MA 01752
  • 27 hours over 3 sessions
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Class Description

Description

What you'll learn in this iso training:

ISO 13485:2016 MD Management System Auditor (Exemplar Global AU and MD)

This is a 3-day course providing the certification of attainment for the following units:

QM - Quality Management Systems (2 days) for MD ISO 13485:2016 QMS Overview Certificate (second day)

AU - Management System Auditing (3 days) for MD ISO 13485:2016 Management System Auditor Certificate (third day)

Attendees can register for 3 days and can add the Lead Auditor portion by attending the 4th day only in the future for Course 106A, an additional $500 cost.

Attendees will learn how to plan, conduct, and assess compliance to ISO 13485:2016 by understanding how to ensure efficient and effective audits.

Learning Objectives:

At the end of this course, attendees will be able to:
1. Understand the development and deployment of the Quality Management System for medical devices
2. Understand all levels of documents required including interpretation of each clause of ISO 13485:2016
3. Understand the differences among FDA QSR, ISO 13485:2003, ISO 13485:2016, and ISO 9001:2015
4. By performing 20+ case studies and dynamic simulated workshop, learn how to audit and demonstrate conformity to the requirements.
5. Learn how to evaluate the effectiveness of the entire QMS, including the process approach
6. Learn how planning, process, and supporting activities can be evaluated effectively.
7. Understand the importance of leadership, risk-based auditing, management review, internal auditing, and the monitoring and measurement of the QMS.
8. Understand the audit process and responsibilities.
9. How to plan, perform, report, and follow-up on audits.
10. Describe the role and responsibility of the auditor, lead auditor, and the auditee at all stages.

Prerequisites:

QMS auditing background. 

Note: All attendees need to study ISO 13485:2016: before attending this class.

Who Should Attend

This course is designed for first, second, or third-party auditors and professionals who may be leading ISO 13485:2016 compliance activities in their organizations. This is also training for those involved with corporate internal auditing activities who wish to broaden their knowledge of a total audit process. This course is also recommended to anyone involved with supply chain management or supplier quality control or assurance.


Refund Policy

REFUND POLICY: (AS PER M.G.L. CHAPTER 255, SECTION 13K)

  1. You may terminate this agreement at any time.
  2. If you terminate this agreement within five days you will receive a refund of all monies paid, provided that you have not commenced the program.
  3. If you subsequently terminate this agreement prior to the commencement of the program, you will receive a refund of all monies paid, less the actual reasonable administrative costs described in paragraph 7.
  4. If you terminate this agreement during the first quarter of the program, you will receive a refund of at least seventy-five percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  5. If you terminate this agreement during the second quarter of the program, you will receive a refund of at least fifty percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  6. If you terminate this agreement during the third quarter of the program, you will receive a refund of at least twenty-five percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  7. If you terminate this agreement after the initial five-day period, you will be responsible for actual reasonable administrative costs incurred by the school to enroll you and to process your application, which administrative costs shall not exceed fifty dollars or five percent of the contract price, whichever is less. A list of such administrative costs is attached hereto and made a part of this agreement.
  8. If you wish to terminate this agreement, you must inform the school in writing of your termination, which will become effective on the day, such writing is mailed.
  9. The school is not obligated to provide any refund if you terminate this agreement during the fourth quarter of the program.
In any event where a customer wants to cancel their enrollment and is eligible for a full refund, a 5% processing fee will be deducted from the refund amount.

Reviews of Classes at Quality & Productivity Solutions, Inc (1)

(5.0-star rating across 1 reviews)
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Review Summary by CourseHorse

Students who have taken classes at ISO 13485:2016 MD Management System Auditor have had positive experiences and learned valuable skills. The instructors and fellow students created an enjoyable learning environment, providing guidance, support, and encouragement. The instructors were well-versed in the subject matter, approachable, and friendly, taking the time to answer students' questions until the concepts were understood. Real-life experiences and situations were used to help students grasp the materials. The setting for learning was top-notch, with visual materials and access to computers to reinforce learning. Students also appreciated the fact that there were no out-of-pocket costs and that the program helped them obtain job opportunities. Insightful Quotes: - "The instructors were well-versed in the subject matter. I found the instructors very approachable and friendly and they took each student's question seriously." - "The instructors also provided real-life experiences and situations which helped the student learn the materials." - "The setting for learning was top-notch and I felt very comfortable with the facility."

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Questions & Answers (1)

Get quick answers from CourseHorse and past students.

Question from Anonymous
Would this course include Lead Auditor certification? Thank you
Answer from Jenn C. CourseHorse StaffCourseHorse Staff
Hi! Yes, the Lead Auditor Certificate will be discussed in class, on the fourth day. You will find this information in the class description.
Answer Show answer
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Quality & Productivity Solutions, Inc

Quality & Productivity Solutions, Inc. is an international firm dedicated to providing practical and effective consulting and training to achieve client objectives. Whether it’s improvement in process, product, service, or overall performance, exceptional results are our business. We partner with...

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Quality & Productivity Solutions, Inc

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