Quality Management System
Building out a QMS, or gearing up for an audit or ISO certification? See how others have reinforced their approach to Quality!
- 14 Topics
- 39 Replies
Thank you for the great participation in this weeks RoundTable on EUMDR Prep! Here are the links that were shared during the discussion - feel free to add to the thread if you have any additional comments or questions.https://greenlightguru.zoom.us/j/99110656160?pwd=Tm9PZUF3d2JveVl2dm01UXRMTDJxUT09https://greenlightguru.zoom.us/j/99110656160?pwd=Tm9PZUF3d2JveVl2dm01UXRMTDJxUT09https://leanraqa.com/free-guides/https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en Thanks again, @KarandeepBadwal, @BenB, @Michelle Lott, & @Brittani.Smith!
Some people just have more guts than I do. Steve Gompertz carried his tri-fold-sized Quality Manual into an FDA inspection, and you know what the inspector said? Check out the video - I’ll let Steve tell the story. Steve has a TON of experience in this field, and loves to help companies implement lean Quality Management Systems. P.S. If you want to skip Steve and my chitchat, skip ahead to the 10-minute mark - we were recording from the get-go!
Due to the pandemic and global supply shortages, more and more supplier audits have had to move to remote or “desktop” audits. Are companies losing anything when they perform a desktop audit in lieu of auditing the company in-person?If so, what do you think is lost? And if a company has no choice but to resort to a desktop audit when onboarding a supplier, how can that company mitigate what might be lost in a desktop audit vs. in-person?
It was brought to my attention that there is a new ISO standard on the horizon!ISO 10010: Quality management — Guidance to understand, evaluate and improve organizational quality culture. This is interesting because this is something that has been percolating my entire career.When I was in manufacturing, I was put in charge of a “continuous improvement” initiative. We put up a giant board in the shop area and asked people to post their continuous improvement ideas as “gems” (short for Gemba Keizen, and cut out in the shape of a gemstone - weren’t we clever??) If/when the ideas were instituted, the employee who submitted the idea got a spot bonus.I know, I know, there were several challenges… Who should do the work of actually implementing the ideas? How come they don’t get a spot bonus? What about people who don’t have time to get involved, or have a harder time coming up with creative solutions?We probably didn’t handle each of those questions 100% correctly… But the point is that we
What books have you found particularly useful? I was going to ask just about books for maintaining a well-organised QMS/documentation repository, but if you found books helpful in other areas I would love to hear about them.For me, I have made heavy use of the two following books and I feel like they have given a lot of value:Software Requirements, 3rd Edition (https://www.microsoftpressstore.com/store/software-requirements-9780735679665) Safety Risk Management for Medical Devices (we have used https://www.elsevier.com/books/safety-risk-management-for-medical-devices/elahi/978-0-12-813098-8, but I just noticed the second edition has been released)
During Sandra Rodriguez’ presentation, she said 53% of QA pros said that their QMS IS effective, while Management says that 87% said their QMS is NOT effective. Sandra didn’t claim to know why there was this discrepancy. Are you in the QA field? If so (or even if not) what is your opinion on this? Love to hear your thoughts!
Hi all, I went through an ISO 13485:2016 audit in 2018 and an MDSAP audit in 2019.Some thoughts…(Hey @AlejandraB - FYI)We were going to do a combined audit, but we changed our minds. Why? We had a lot of changes to make to our QMS to go from our current 13485 version to the 2016 version due to our cert expiring and I felt like those changes were enough, without adding all of the MDSAP changes too. We needed to retrain the entire company to all of the new/changes docs in the QMS early enough to be able to create records before the audit. Part of the changes we made included a complete rewrite of our Internal Audit process and we needed to train internal/lead auditors to the new 13485:2016 spec and audit ourselves to the 2016 version before the audit. Part of the changes included an overhaul of the Management Review process and Quality Objectives, BIG things to change. We needed to improve our Customer Complaint Handling process. We improved how we collected, investigated, and manag
FDA released a proposed rule to change the current Quality System Regulation (QSR) to align with the ISO13485:2016 standard. How is this going to impact companies in the U.S., or companies only focused on the U.S. market who have not gone through the ISO13485 certification process?I’m curious to hear the potential positives and negatives of this proposed change.
What are some of the most helpful Quality Objectives and KPIs your team has used to measure success during the premarket phase? I’ve seen success in setting objectives for fewer findings from Internal Audits, better on-time training completion, and fewer process deviations. What other premarket quality objectives and KPIs have you found to be successful?
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