This two-part ISO 13485 webinar explains how to update your quality system documentation to comply with ISO 13485:2016.
The first ISO 13485 quality system I created was in the Spring of 2004. In 2011 I started posting blogs on the Medical Device Academy to help medical device companies implement ISO 13485 quality systems. In 2012, I began building a library of quality system procedures for a turn-key quality system and selling the procedures from our website. Dozens of consulting clients have successfully achieved ISO 13485 certification with our quality system procedures. Since 2004 I created, audited, and fixed hundreds of ISO 13485 quality systems, but my first quality system is the one I’ll never forget.
Fast-forward to 2020
Medical Device Academy is currently helping 18 companies implement their first ISO 13485 quality system for compliance with ISO 13485:2016. We successfully helped four companies achieve ISO 13485:2016 certification this year, and we are currently preparing several companies for their Stage 1 certification audits.
My previous webinars on the 2003 version of ISO 13485 are split into two parts: Stage 1 and Stage 2. I did the same for this 2016 training. Stage 1 focused on the change to the following processes:
- Management Review
- Internal Auditing
- Quality System Documentation
The Stage 2 webinar focus is other changes to the ISO 13485 Standard:
- Change Control
- Customer Related Processes
- Design Controls
- Supplier Controls
- Process Validation
- Acceptance Activities
- Incoming Inspection
- UDI Requirements
ISO 13485:2016 Webinars
The webinars explaining the requirements for ISO 13485:2016 are being updated for 2020. Anyone that purchased these webinars previously is receiving free access to the updated training webinars. If you are making a new purchase of these two training webinars, the webinars are only being sold as a bundle for $258. You get:
- an invitation to the live webinar for Stage 1 – July 24, 2020 @ 2 pm EDT
- an invitation to the live webinar for the Stage 2 – July 28, 2020 @ 8:30 am EDT
- native slide decks for both webinars
- links to download a recording of the webinars
These webinars explain precisely what you need to do to implement a quality system compliant with ISO 13485:2016. After you create your own plan (free template is provided with subscription), then you can show the recording of these two webinars to your management team so they can implement your plan in the next several months. All deliveries of content will be sent via Aweber emails to confirmed subscribers.
Previous recording of ISO 13485:2016 webinars?
The ISO 13485 webinars were recorded in 2015 for the ISO 13485:2003 version of the standard, and then the webinars were updated in 2016 and 2018 for ISO 13458:2016. We are recording updated webinars that will help you avoid some of the most common mistakes we have seen people make when they implement a new quality system. If you already purchased the webinars, you will receive an automated email inviting you to participate in the webinar. If this is a new purchase of the webinar, you will receive a link for downloading the old webinar and an invitation to participate in the new live webinar. Everyone that purchases the webinar will receive a link to download the recording if you are unable to attend the live webinar.
Webinars are hosted live via Zoom, but the duration is relatively consistent at approximately 60 minutes plus 15-30 minutes of Q&A.
If you have any general questions about gaps between 2003 and 2016, please email me at firstname.lastname@example.org. I will use your questions as material for the webinars and future blogs. During the webinars, you will only be able to submit questions via the chatbox. If you have company-specific questions, please send me a request to set-up a private call to discuss your specific issues.
This ISO 13485:2016 training package is only available as a bundle:
Download links to previous recordings for the 2003 quality system training webinars, native slide decks for the new 2016 version webinars and links to download a recording of the new webinars.
Exam and Training Certificate available for (2016 Update) $49.00:
This is a 20 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.