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

14 Topics

Etienne
EtienneCommunity Manager
published in Quality Management System

Expectations vs. Reality: Bringing a Device to Market

What was your biggest takeaway from the report?Is there anything you plan to do differently in the coming year based on some of the findings?We’d love to hear any and all feedback in the comments!Also! If you haven’t download the report yet, you can find it at this link. 

1541
Etienne
8 days ago
Etienne
EtienneCommunity Manager
posted in Quality Management System

EUMDR Prep

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!  

2
Etienne
2 months ago
Etienne
EtienneCommunity Manager
asked in Quality Management System

MDSAP Prep

Thank you, @DavidShanes for your fantastic presentation on preparing for the MDSAP!  P.S. @sara.adams is planning to watch this and she will be the one to pass final judgement on how well you did. THANK YOU!!!

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DavidShanes
2 months ago
Etienne
EtienneCommunity Manager
posted in Quality Management System

AMA on QMS Implementation

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!  

4
Etienne
4 months ago
Etienne
EtienneCommunity Manager
posted in Quality Management System

Remote vs. In-Person Audits

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?

0
Etienne
5 months ago
Etienne
EtienneCommunity Manager
posted in Quality Management System

New ISO Standard on Improving Organizational Quality Culture!

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

0
Etienne
5 months ago
Etienne
EtienneCommunity Manager
posted in Quality Management System

From NC to CAPA - where's the line?

How do you determine if a Nonconformance requires a CAPA? It is a particular risk threshold, a specific number of recurrences, or whether or not management heard there was an NC? I’d love to hear how you make this determination at your organization.

4
Etienne
5 months ago
JimSkinner
JimSkinnerNew Participant
posted in Quality Management System

Useful books

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)

2
JimSkinner
6 months ago
Etienne
EtienneCommunity Manager
posted in Quality Management System

QMS efficacy - QA vs. Managements opinion ?

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!

8
DavidShanes
7 months ago
markalpert601
markalpert601Employee
posted in Quality Management System

Quality as a Competitive Advantage

I’m interested in hearing examples from the field. How does your company view quality as a competitive advantage? 

3
Etienne
7 months ago
DavidShanes
DavidShanesInspiring
posted in Quality Management System

Medical Device Single Audit Program - MDSAP and ISO 13485:2016 audits

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

2
DavidShanes
7 months ago
Etienne
EtienneCommunity Manager
posted in Quality Management System

FDA's proposed rule to align the QSR to 13485?

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.

5
C
9 months ago
A
Ankitha NairNew Participant
posted in Quality Management System

Company Name Change

What are some of the factors that should be considered from both quality and regulatory standpoints when you think of a company name change/organizational change/address change? 

3
C
9 months ago
WADE SCHROEDER
WADE SCHROEDERCommunity Manager
posted in Quality Management System

Premarket Quality Objectives and KPIs

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?

2
Rebecca Sheridan
9 months ago

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