ISO 13485:2016 MD Lead Auditor

Name: ISO 13485:2016 MD Lead Auditor
Start: 2022-11-15T08:30:00-05:00
End: 2022-11-15T17:30:00-05:00
Location: Quality & Productivity Solutions, Inc

at Quality & Productivity Solutions, Inc - Marlborough

(22)

Course Details

Price:

$1,895 15 seats left

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Start Date:

Tue, Nov 15, 8:30am - Nov 18, 5:30pm Eastern Time (4 sessions)

Location:

Marlborough
28 Lord Road, Ste 205
At Elm Street
Marlborough, Massachusetts 01752 (Map)

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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 Lead Auditor (Exemplar Global TL and MD)

This is a 4-day course providing the certification of attainment for the following units:

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

TL - Leading Management Systems Audit Teams (4 days) for MD ISO 13485:2016 Lead Auditor Certificate (fourth day)

MD - Medical Devices

Attendees can register for 3 days for course 106B and can add the Lead Auditor portion by attending the 4th day in the future. This is a certified Exemplar Global course. To attain registration as a QMS auditor, senior auditor, or lead auditor, attendees must pass the written examination, earn a passing grade (70% score) in course assessments, and meet all prescribed professional requirements of attendance, participation, and learning objectives.

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)

You may terminate this agreement at any time.
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.
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.
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.
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.
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.
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.
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.
The school is not obligated to provide any refund if you terminate this agreement during the fourth quarter of the program.

Map

Quality & Productivity Solutions, Inc
Marlborough
28 Lord Road, Ste 205
At Elm Street
Marlborough, Massachusetts 01752 Marlborough
28 Lord Road, Ste 205
At Elm Street
Marlborough, Massachusetts 01752

All classes at this location

Start Date	Time	Teacher	# Sessions	Price

Tue, Nov 15	8:30am - 5:30pm Eastern Time	TBD	4	$1,895
This course consists of multiple sessions, view schedule for sessions.
Wed, Nov 16	8:30am - 5:30pm Eastern Time	TBD
Thu, Nov 17	8:30am - 5:30pm Eastern Time	TBD
Fri, Nov 18	8:30am - 5:30pm Eastern Time	TBD

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