ISO 13485:2016 QMS – Lead Auditor Preparation Exam

ISO 13485:2016 standard is made on the quality philosophy of Plan, do, check and Act Cycle. The standard is based on regulatory frameworks like FDA 21 CFR Part 820 and ISO 9001:2008. Organizations have to check themselves whether their operations are done according to plan phase or not. Similarly if you are a quality professional and ISO 13485 beginner, or expert you also have to check your expertise in Quality Management System. This “knowledge validation exam” helps you to check and validate your knowledge on ISO 13485:2016 standard and its fundamental concepts like importance of regulatory compliance, medical device file, product recall and advisory notices etc.

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Value Addition Alerts:

1. Passing Certification Awarded By Instructor

2. Road Map for Further Learning

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Alert >> New Audit Case Studies:This course comes with exclusive 4 audit case studies. You need to assess the situation and select the right option. If in case you select the wrong option, there is an explanation provided at the end of the assessment. Moreover, you can discuss the audit case studies as well in Q & A by stating the reference code provided with each study. There can be other correct alternatives for case studies, so you are free to share the alternative with reference to the specific case.

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Certification:Udemy does not provide certification for exams, they only do in the case of Video Courses. But the great news here is, we have empowered our paid students to have a certificate, once they qualify by 80% in the exams. It is a manual process, in which learners our requested to submit evidence of qualification, and apply for the certificate. The certificates are issued at the end of a month.

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Exam Composition

You will be assessed when you take this online exam in following areas (Course Objectives):

• The publication of new ISO 13485 standard

• The specific differences between ISO 13485:2016 and the older versions

• PDCA Approach

• Regulatory Compliance

• Medical Device Files

• Design and Development Process

• Product Recall and Complaints

• Internal Auditing

• ISO 13485:2016 interpretation in companies

• Improvement

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Food for Thought

Be Familiar with ISO 13485:2016 knowledge which you hold…

If you think you are an expert in ISO 13485 after taking courses on the subject and working with ISO 13485…

You need to hold on!

Join this exam and self assess yourself!

Maybe you need to learn and learn…

Or you can prove your knowledge and expertise by successfully completing this exam.

Both ways, you are in a win-win situation.

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Note: ISO 13485 standard is a copyright document of ISO. We will not be sharing the standard. Please purchase it from ISO store.

Good news: We will be adding more content for example case studies to practice tests in the future. If you feel that you lack the knowledge you can take ISO 13485 courses from Udemy or the instructor to guide you on gaining ISO 13485 knowledge.

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One Month Money Back Guarantee:Don’t forget One Month 100% Money Back Guarantee without inquiry. This means you have unconditionally no risk when registering to this Course.

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Ask Questions & Report Complaints:Discussion forum on the right side of this course can be used to discuss specific queries and report problems you are facing about the content of the course.

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Take this course: Follow the “Take This Course” Button by clicking at the Top Right Hand Side of the Page. Proceed with the instructions and follow it to register and pay for the course.

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• 1 stars: 6 votes
• 2 stars: 4 votes
• 3 stars: 15 votes
• 4 stars: 22 votes
• 5 stars: 16 votes

Frequently Asked Questions

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