ISO 13485 QMS Foundation Training

PAS012   Type: E-Learning

The ISO 13485 QMS Foundation Training – a certified online course by Punyam Academy – will help attendees understand the ISO 13485 medical devices quality management systems (QMS) and clause wise requirements of ISO 13485:2016 standard.

ISO 13485 QMS Foundation Training

Description

This online course will help attendees gain complete knowledge of ISO 13485:2016 requirements as well as quality management system implementation in the organizations involved in design, manufacture, storage, distribution, service and commissioning or decommissioning (as applicable) of medical devices. This knowledge can be very useful for those who want to establish, implement, maintain and improve a quality management system in their organization and get it certified for ISO 13485:2016. QMS foundation training course for ISO 13485 has been designed taking into consideration the convenience of attendees. In a short time, this course will satisfy part of the formal training needs of individuals seeking knowledge about QMS requirements, documentation needed for QMS and steps for QMS certification. This course will provide attendees an overall awareness of QMS.

Content Covered in the ISO 13485 Foundation Training – Online Course

The ISO 13485 QMS Foundation Training – online course contains video tutorials recorded by experienced QMS trainers and handouts in .pdf formats to download as well as online session exams and final exam.

Videos:
This part of the training provides online training video tutorials of ISO 13485 clauses requirements, QMS documentation, steps for ISO 13485 QMS certification, etc, all-important sessions of this course are covered and delivered by an experienced tutor.

Handouts:
For all the above three sessions, the ISO 13485 handouts are given in pdf format. The participant of this ISO 13485 QMS training can download and save the handouts in their computer for future reference and read them offline, anytime and anywhere.

Online Exams:
The participant of this online course will be required to clear all session exams and one final exam, which are given as a part of the course. After successfully passing the final exam, his/her auto-generated Certificate will be issued and can be downloaded and printed from the dashboard.

Course Objectives

  • Familiarize yourself with Medical Devices Quality Management System (QMS).
  • Understand the requirements given in each clause of the ISO 13485:2016 standard.
  • Familiarize yourself with the QMS documented information.
  • Understand the ISO 13485:2016 QMS implementation and steps for quick certification.

Who Can Enroll in This Course?

This course is for those requiring an introduction to the ISO 13485 QMS standard, especially those involved in the establishment, implementation and management of a quality management system in medical devices organizations. It has been especially designed keeping in view the needs of:

  • Company Executives / Managers/ Supervisors/QMS implementers
  • Management Representatives,
  • QMS Consultants,
  • Management Students.

AUTHORS & INSTRUCTORS

For details of the authors, trainers and instructors experience and background, please visit our trainers page. They have very rich experience on the subject.

STUDY MATERIALS

This e-Learning course is provided with study materials and you can read it after your log in or download (PDF format). Use the study materials to reinforce key points and to keep a reminder of what you already learned as well as you can save it in your computer for future reference. The access of this study material is removed after exam is cleared and on line certificate is prepared for the student.

EXAMINATION AND COURSE CERTIFICATE

All paid E-learning course includes the Course Certificate that is issued upon course completion and passing the session exams as well as a final exam given in the course with minimum 60% marks. The option to reappear in the exam is also given to student, if failed in any exam.

END OF COURSE INSTRUCTION

After completing the session and passing each session examination the student can appear for final exam. Once the final exam is cleared then it is considered a end of course. The training certificate is ready on our LMS and student can print it or save the training certificate. It is also available for verification by entering the name and certificate number.

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Why Learn with us?

Why Learn with Punyam Academy Online Training

How To Get Certification?

How to get Certified for Online ISO Auditor Course
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What Our Customer Says...

Blaizon C Mathai
Abu Dhabi, UAE

I would like to extend my sincere gratitude in introducing this program. Course material and presentations very valuable indeed and informative too. Even presentations made in simple language

Maria Garcia
California, USA

Great e-learning course by Punyam Academy, easy to use and learning can be done at your own pace. Material and content provided is exceptional. I would definitely recommend to anyone

Paul Thompson
South Africa

My first online course experience and it was pleasant to attend PAS102. I found the course to be very thorough and covered all aspects that are needed to carry out auditing.

Mary Smith
Dubai, UAE

The course has good information for new auditors or anyone that wants to be an internal auditor for understanding the standard. The content was very relevant, and the process of assessment required me to really understand the coursework

Nancy Lewis
South Africa

I was very happy to be able to complete the course online. I enjoyed being able to complete the course at my own pace. The support from Punyam Academy team has been great. Thanks!

Edward Anderson
California, USA

A valuable online opportunity to further skills and knowledge. Enrol for ISO/IEC 17025 auditor course, and fills best certified course in minimum cost

John Davis
Abu Dhabi, UAE

Excellent training at Punyam Academy, friendly atmosphere and lovely staff, highly recommended. Voice enable presentation gives me filling like live training, which saves my time.

Jennifer Nelson
UAE

Best place to go for ISO/IEC 17025:2017 Internal Auditor training. I have attended classroom training and found them extremely beneficial and enjoyable. Trainers are very understanding and knowledgeable.

Daniel Johnson
Washington, USA

I appeared for ISO 45001 auditor training course. Highlight of this course is good audio visual presentation, study material to download as well as exams to review my knowledge.

Charles Wilson
Abu Dhabi, UAE

Congratulations to Punyam Academy team for providing best knowledge sharing platform online. Achieved ISO 9001 internal auditor certificate, looking forward to enrol next auditor course very soon.

Karen Smith
California, USA

The course more economical compared to classroom training and flexible timings make it more recommendable. Looking forward for more complex courses like PMP, IRCA certified courses etc.

Ajit Patel
Altrafine Gums

I am highly satisfied with your course on food safety management system. Now I am fully aware about FoSTaC requirements and appreciate efforsts of Punyam Academy throughout the training session.

Dr. Bharat Agrawal
Analytical Development Laboratory Torrent Research Center

The training materials given by Punyam Academy experts proved to be very useful in managing our own requirements. We appreciate trainer's knowledge and efforts in delivering good sessions. All the best for upcoming training programs.

Alpesh Patel
Meghmani Industries Limited

I am happy with the certified ISO/IEC 17025:2017 auditor training course at Punyam Academy. Now I am fully aware about ISO/IEC 17025:2017 transition auditing and quality management requirements for testing laboratory.

Shreeyansh Kumar
ISRO

Thank you Punyam Academy for providing me world class learning at affordable cost. Trainer has very good knowledge about subject. Training environment & facility at training center is exceptional.

Dattatray Sawarbandhe
CEO, Bombaywalla Foods

A great step has been taken by organizing Food Safety Training and Certification (FoSTaC). This knowledge sharing will only bring all the business motive together of common standard, quality and good healthy surrounding. My India is growing - Keep it up Punyam Academy.

Subhashchandra Pathak
Terapanth Foods Limited

Attending FoSTaC training course for food safety management system is awasome experience. Now I am fully aware about food and quality management requirements in food manufacturing organization.

Sachin Patel
Mazda Limited

Attending classroom training at Punyam Academy was a wonderful experience. I got the opportunity to learn FSSAI requirements as FoSTaC training from experienced instructors.

Sajan Peter
Saudi Arabia

I have purchased and successfully completed ISO 9001:2015 certified internal auditor training course. It is Very professional and helpful training program customised to achieve maximum customer satisfaction.

John Watson
United Kingdom

Training material was of a high standard. Exams were very goo and made you think.

Billy Croker
United States of America

Very good and through course. Make you really think about somethings and the way you perform an audit.

Irron R Collins
United States of America

Course is very informative, easily understood and provides good understanding of requirements as needed. However could not print my certificate.

Bibi Ruwaydah Soreefan
Mauratius

I loved the course. Just what I needed for my calibration journey. Looking forward to taking more courses at Punyam Academy.

Jose Cabrera
United States of America

The material provided during the course was adequate to provide the required knowledge of ISO 13485:2016 in preparation for each session exam and final exam. Very happy with the course, will recommend it to other colleagues.

Dr. A. K. Gupta
India

Nicely prepared learning programme , helpful to prepare Quality Manual and accreditation for laboratory.

KEITH SPENCER
Trinidad and Tobago

The course was very comprehensive and practical! An indispensable training resource for prospective ISO 45001 lead auditors.

UK Lee
South Korea

It was very helpful to get ISO 14001 auditor qualification, thanks a lot.

PARTH SHIKHARCHANDRA JAIN
India

Well defined Training Program... Thanks...!!!

Johan Pretorius
South Africa

The course was very comprehensive and practical! every thing is well explained.

Maud Van Looy
Belgium

The content of the training was very useful to the team, and all of our team members have completed the training successfully.

Shiv Prakash Bhutra
India

There was a good pace and tone to the training in online E- learning course, which kept it interesting throughout.

Rohit Prajapati
India

The design of the course, including clarity of presentation, quality of video and audio, session exam are excellent.

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