This two-part webinar explains how to update your quality system documentation to comply with ISO 13485:2016 that was released on March 1, 2016.
The first quality system I created was in the Spring of 2004. I became a crazy workaholic and it led to a divorce the following year. 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 2016
Now the company I worked for 2004 needs to update their quality system to the 2016 version of ISO 13485. My friend Joe is the quality manager at that company and I’m sure that he won’t be working 100 hours a week for 6 months to update the quality system. Joe’s an enlightened quality manager. He knows that his job is to lead other managers and help them update the procedures for their departments. His job is to train them on what has changed. Joe could spend a couple of days reading the 2016 version and then create his own training material for the management team, but Joe’s smarter than that. Joe looks for a training that someone has already created for the 2016 version.
Joe already has a recorded training webinar for ISO 13485:2003, but he needs new material to explain the gaps between the current 2003 version and the new 2016 version. Joe will create his own quality plan for updating his quality system to the 2016 version. Joe might even download my quality plan template and substitute his own procedures for mine. However, he still needs training material on the gap between 2003 and 2016.
On March 24 I conducted a live training on the gap between the 2003 and 2016 versions to help Joe and my other clients. 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 webinar for Stage 1 was live and the Stage 2 webinar was recorded due to technical difficulties. 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
These two training webinars are only being sold as a bundle. The cost is $129 each for a total of $258. You get:
- previous recordings for the 2003 quality system training webinars
- native slide decks for the new 2016 version webinars
- links to download a recording of the webinars
These webinars explain exactly what you need to do for updating your quality system to the 2016 version. After you create your own plan (free template is provided with subscription), then you can show the recording of these two webinars to your own 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.
Webinars are typically recorded live but duration is fairly consistent at just under 60 minutes with Q&A. The Stage 1 presentation has 30 slides and the Stage 2 presentation has 22 slides. The Stage 2 also has much more content on each slide.
If you have any generic 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 chat box. 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.