ISO 13485:2016 MD Management System Auditor

at Quality & Productivity Solutions, Inc - Marlborough

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Course Details
Price:
$1,495 15 seats left
Start Date:

Mon, Jun 06, 8:30am - Jun 08, 5:30pm Eastern Time (3 sessions)

Location:
Marlborough
28 Lord Road, Ste 205
At Elm Street
Marlborough, Massachusetts 01752
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Description
Class Level: Intermediate
Age Requirements: 18 and older
Average Class Size: 15

What you'll learn in this iso training:

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

QPS is an Exemplar Global certified training provider for the following competency units contained in this class. Attendees successfully completing this course will receive a certificate of Attainment for these units.
AU- Management System Auditing 
MD -Medical Devices
TL-- Leading Management Systems Audit Teams
Attendees will learn how to audit and lead an audit team including how to assess compliance to ISO 13485:2016. understanding how to plan, conduct, follow-up on, and work with audited
organizations to ensure efficient and effective audits. Students gain necessary auditing skills
through formal class work, role playing, group workshops and open forum discussions.

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.



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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.

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Start Dates (1)
Start Date Time Teacher # Sessions Price
8:30am - 5:30pm Eastern Time TBD 3 $1,495
This course consists of multiple sessions, view schedule for sessions.
Tue, Jun 07 8:30am - 5:30pm Eastern Time TBD
Wed, Jun 08 8:30am - 5:30pm Eastern Time TBD

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Questions & Answers (1)

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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.
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