Medical Devices Quality Management Systems

ISO 13485 Series

for Engineers, Industry Professionals, Business Executives, Consultants, Freelancers and Entrepreneurs working in IT, Manufacturing, Construction, Services
Online Self Learning Modular Courseware

@ ₹5,000 ₹3,000 only !

Understand the Philosophy of ISO
Understand how to ensure the highest standards of quality in medical device
Enhance safety and quality of food products
Best practices in food safety management
Learn enhanced patient safety
Build rewarding Career as an ISO Expert
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ENGGtalks® | Professionals

Building Tomorrow with Quality Today: ISO 9000 Standards in Action!

Interactive Courseware

Videos & Text Content

Flexible Timing

Device Friendly

Certificate of Completion

Key Takeaways

Basic Philosophy of ISO Certification
Improved Operational Efficiency
Guidance through Various Frameworks
Different Processes Step by Step
Various ISO Standards
Benefits and Drawbacks
Duration: 50 Hours

Topics Covered

  • A Brief History behind the formation of ISO
  • Name and Abbreviations
  • ISO Name & Logo
  • Organizational Structure of ISO
  • Membership
  • Financial Functioning of ISO
  • Benefits for Business
  • Benefits for Society
  • Benefits for Government
  • Drawbacks of ISO
  • ISO Certification Process
  • Accreditation
  • Labeling for ISO certification
  • Conformity Assessment Committee (CASCO)
  • CASCO’s Vision
  • Technical Standards
  • Management Standards
  • Industry-Specific Standards
  • National Standards
  • International Standards
  • Company Standards
  • Six Sigma (6σ)
  • Popular standards developed by ISO
  • ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes.
  • ISO/TR 14969:2004 Medical devices - Quality management systems - Guidance on the application of ISO 13485: 2003.
  • ISO 14971:2019 Medical devices - Application of risk management to medical devices.
  • ISO/TR 24971:2020 Medical devices - Guidance on the application of ISO 14971.
  • ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
  • ISO 11137 - Sterilization of health care products - Radiation
  • ISO 11607 - Packaging for terminally sterilized medical devices.
  • Sustainable Development Goals
  • Includes 3 videos
Transforming Challenges into Quality Triumphs!

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Frequently Asked Questions

This course will help any individual or organization to implement and maintain the ISO standard, to improve the effectiveness of quality management system, and prepare for a certification audit. It will also enhance skills and knowledge in quality management, which can benefit in the long run.

Industry Professionals, Entrepreneur, Consultants, Subject Matter Experts and Freelancer

This Program is a self-learning online Courseware which has been designed, developed by a team of consultants and veteran industry experts associated with ENGGtalks

Registered candidates can avail this course through their PC’s, Laptop, Tab & Samrtphones.

There is no fixed timeline for this course as it is an online self-learning course module.

No. There is no refund option available after enrollment except duplicate payment by the candidates.

Please check our Refund Policy

The payment mode is fully ONLINE. There is a link to the payment gateway in the online application form. The candidate can opt for any of the payment options listed over there. The additional charges (if any) such as service charges, processing fees or bank charges, have to be borne by the candidate.
All kind of online payment process is available. i.e. Debit card, Online banking, UPI, e-wallet etc.

Anyone can drop the course anytime but amount cannot be refundable.

Registered candidates may raise their quires/suggestions through mail which will be taken care by the experts at ENGGtalks platform to assist the candidate.

Please Follow the steps given below to access your course.

  1. Login with your credential
  2. Click on "My Courseware" tab
  3. Click on the respective course to start learning.

Yes, it is a self-learning course module to understand the requirement and implementation to get standardize as per ISO.

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