What does ISO 13485 Certification Mean?

ISO 13485 Certification is recognition from an accredited Certification Body (CAB) or a Notified Body (in relation to EU regulations) , that an organization has implemented and is maintaining a Medical Device Management System (MDMS) that meets the requirements of ISO 13485:2016.

Who Should Get ISO 13485 Certification?

All organizations involved in one or more stages of the life-cycle of a medical device, particularly component manufacturers or logistics companies wishing to break into the medical device sector , can benefit from ISO 13485 certification.

What are the Advantages of Having ISO 13485 Certification?

There are at least fourteen benefits that organizations with a medical device quality management system in place can enjoy such as: A body of evidence to demonstrate compliance with applicable legal and regulatory requirements. Under EU MDR and IVDR there can be a formidable mass of documentation required Management systems that are more efficient, consistent and reliable All aspects of supply, installation, maintenance throughout the product lifecycle are done in compliance with applicable regulations. Organized management: An organization certified to the Standard is managed in a standard and structured way Clarity of Purpose: Staff are clear as to their responsibilities, authorities, and accountabilities Processes and procedures suited to the Mission and strategic objectives you have set for the organization. Internal audits to monitor compliance with requirements and highlight deficiencies. Corrective actions to prevent recurrence of errors – try to make mistakes only once, if at all. Informed Board of directors knowing that the organization is focused on strategic objectives while satisfying compliance requirements, and planning and acting to address future challenges. Management satisfaction knowing that the organization is functioning in line with strategic objectives. Reduce errors: Fewer costly errors, less rework, replacement of goods and/or services, and increased productivity. Fewer customer complaints as fewer errors occur. Better retention of customers: again, a consequence of reduced errors. Management performance improved as less time spent apologizing to customers and managing the unnecessary repetition of work.

How Do You Get ISO 13485 Certification?

ISO 13485 Certification is issued by CABs to organizations after they have gone through an ISO Certification process. This is based on a comprehensive 2-stage audit (itself based on the auditing standard, ISO 19011 ), that involves a review of documentation and an independent on-site audit. The CAB gathers and documents objective evidence of compliance with the requirements of ISO 13485. After the CAB has confirmed that all the requirements of the ISO 13485 Standard have been implemented and are being maintained, a Certificate is issued as is permission to use logos to publicise the fact. For a more information, please refer to our guide on how and what to prepare for ISO 13485 certification.

What kinds of ISO 13485 Training Courses are Available?

Conventional classroom-based ISO 13485 auditor courses usually limit you to two choices: a 2-day internal auditor course and a 5-day lead auditor course . Sometimes, this makes selecting an appropriate ISO 13485 course a bit challenging . With deGRANDSON’s e-Training programs that allow you to enroll in online courses that you can take anytime and anywhere you want, you have additional options to choose from so you can pick the one that fits your needs best. In addition to our ISO 13485 internal auditor and lead auditor courses, deGRANDSON also offers a lead implementer course for those who want to become an MDMS consultant , an extension course for those who want to add ISO 13485 to their existing internal or lead auditor certification, and a conversion course for those who want to upgrade their current ISO 13485 certification to the latest standard. For more detailed information, check out our answers to 26 frequently asked questions about ISO 13485.

ISO 13485 Training Courses

ISO 13485 Training Courses
*Course*	*Purpose*	*Delivery*	*Duration*
ISO 13485 Internal Auditor	To conduct effective internal audits	Online	12 hours
ISO 13485 Internal Auditor Refresher	To update current certification	Online	8 hours
ISO 13485 Internal Auditor Extension	To add to current certification	Online	8 hours
ISO 13485 Lead Auditor	To programme and conduct internal audits	Online	36 hours
ISO 13485 Lead Auditor Refresher	To update current certification	Online	27 hours
ISO 13485 Lead Auditor Extension	To add to current certification	Online	27 hours
ISO 13485 Lead Implementer	To implement and maintain an MDMS	Online	30 hours

INFOGRAPHIC: ISO 13485 Course Selection

Infographic- Choice of ISO 13485 Courses

Courses have been updated February 2022

Our Courses have been updated to include …

Introduction to Regulations and Guidelines – EU, UK and USA
Annex ZA and ZB of ISO 13485:2016 Amendment 11

ISO 13485 Overview

What is ISO 13485?

ISO 13485:2016, the latest version of the ISO 13485 standard, is an internationally-recognized standard that sets out the requirement for a Medical Device Management System (MDMS).

It was initially published in 1996 as ISO 13485:1996 and revised in 2003. Associated standards since replaced by ISO 13485 include ISO 13488, EN 46001 and EN 46002. The current standard has been adopted by the EU as a harmonized standard with the title EN ISO 13485:2016.

EN ISO 13485:2016 is identical with ISO 13485:2016, sometimes referred to as the international version, except for the addition of 3 Annexes related to EU Directives. Do note that these Annexes are now out-of-date as they do not correspond with the current EU Medical Device Regulations (EU Regulation 2017/725 for medical devices and EU Regulation 2017/726 for in-vitro medical devices).

What is ISO 13485 Training?

ISO 13485 involves training programs designed to equip auditors, lead implementers, quality managers, and other management system professionals with the necessary skills and knowledge to develop, implement, maintain, or audit Medical Device Management Systems and ensure their compliance with the requirements of ISO 13485.

Is ISO 13485 Training Mandatory?

Yes and No.

Management Representative or other professionals with day-to-day responsibility in maintaining an MDMS are not required to undergo ISO 13485 training. It is instead implied as already part of developing competence. It is not a specific stand-alone requirement.

That said, ISO 13485 training is strongly recommended as effective internal audits are essential to doing a professional job in maintaining your Medical Device Management System and preparing it for Certification Body audits.

How Can I Enroll in an ISO 13485 Training Course?

You can enroll in any of deGRANDSON’s online training courses by going to the product page of the course you want to enroll in. Once there, add the course to your cart and then proceed to checkout and payment.

Once you’ve paid for the course, you will be asked to provide the email address or addresses of the people who will be enrolling in the course. They will then receive an email providing the username and password they would need to access deGRANDSON’s Learning Management System where the training is delivered.

Please see this video to see a more visual demonstration of the enrollment process.

Need more information on ISO 13485 Certification?

Check out our answers to Frequently Asked Questions. Just click this image …

Here you'll find the ISO 13485 Training Course you want

Your specific situation will determine which is the best course for you.

I want ISO 13485:2016 Internal Auditor Certification. Which course should I take?

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This ISO 13485 Internal Auditor training course is the course you need to become a certified internal auditor and be qualified to perform internal audits.

See the ISO 13485 training you need to carry out effective internal audits here.

I'm newly responsible for my organization's Medical Device Management System. Which course should I take?

Quality Managers who don’t feel confident about ISO 13485: 2016 and its requirements are suited for this ISO 13485 Lead Implementer course. It will help you understand what an efficient and effective Medical Device Management System looks like.

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We manufacture medical device components. I've been tasked with getting our ISO 13485 certification. Which course should I take?

Our ISO 13485 Lead Implementer course is ideal for you. You may need some consultancy support on implementation, but that should be limited. Furthermore, you’ll know the ‘right’ questions to ask.

Implementing a Medical Device Management System yourself can be challenging. However, it’s a great way to quickly introduce changes needed to secure and retain ISO 13485 certification.

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I'm a Medical Device Management System Lead Auditor and want to upgrade to the new Standard. Which course should I take?

Update your Lead Auditor certification to the latest standard with this 24-hour ISO 13485:2016 Lead Auditor Conversion Course.

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I'm already a Lead Auditor and I'd like to add ISO 13485:2016 to my auditor certification. Which course should I take?

This 24-hour ISO 13485 Lead Auditor Extension course will let you add ISO 13485 to your lead auditor certification.

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I want ISO 13485:2016 Lead Auditor Certification. Which course should I take?

This ISO 13485 Lead Auditor course provides in-depth knowledge of the Standard and of Auditing skills. This is the certification you need if you hope to audit for a Certification Body.

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We're certified in the old standard. Now, I want to upgrade our Medical Device Management System to meet the ISO 13485: 2016 requirements. Which course should I take?

This Transition Training package includes an ISO 13485: 2016 Implementation Handbook. Packed along with it is a documentation toolkit, lots of sample paperwork, and a Gap Analysis Tool.

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I want to be an Medical Device Management System Consultant. Which course should I take?

This ISO 13485 Lead Implementer course includes a 33-step Path to Certification, a 100+ page ISO 13485: 2016 Implementation Handbook.

It also includes a Documentation Toolkit that contains sample SOPs and record forms. Examples of audit schedules and management review agenda are included as well. Truly beneficial to a new MDMS consultant.

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I'm a Medical Device Management System Internal Auditor and need to learn about the revised Standard. Which course should I take?

Upgrade your ISO 13485 internal auditing skills in accordance to the latest revision with this 8-hour ISO 13485:2016 Internal Auditor Conversion Course. Moreover, you can get it at a fraction of the usual time and cost it takes to finish the course.

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I'm already an Internal Auditor and I'd like to add ISO 13485:2016 to my auditor certification

This 8-hour ISO 13485 Internal Auditor Extension Course will let you add ISO 13485 to your internal auditor certification.

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