qmsWrapper Blog
Cup of Joe 39# - Key factor during an audit–prepared employees
A successful audit relies on communication. The most important step is the preparation of employees for how to interact with the auditors.
Cup of Joe 38# - There is such a thing like painless audit?
How to overcome the auditor's visit that always generates tension and anxiety? Track our guide.
Cup of Joe 37# - Why we have to perform an audit?
At work, nothing raises the hairs on the back of your neck like the word “audit”. Find out why it is that much important.
Cup of Joe 36# - Scary word “Audit”
Audits are carried out in order to confirm that the individual elements within the system are effective and suitable for achieving the stated objectives.
Cup of Joe 35# - Signing your electronic documents
One of the main criteria for an eQMS is to have implemented an electronic signature. Why? How?
Cup of Joe 34# - How to organize your folders?
Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS.
Cup of Joe 33# - Revision History helps you with transferring to eQMS
One of the main fears when transferring from paper-based to eQMS is how to handle a lot of file versions, how should we name them, etc.
Cup of Joe 32# - Good Customer Service Reduces Problems
While you can’t run a perfect business with all smooth situations, at qmsWrapper we can ensure friction doesn’t become an issue.
Weekly Cup of Joe 31# - Move Your Budget into the Right Direction
There are countless benefits to implementing a QMS. Think of the investment in modern QMS software as an investment in preventing quality issues.
Top 20 Medical Device Conferences and Trade Shows 2019
We scoured the web for high-quality conferences in 2019 and made a list that every medical device manufacturer must attend.
Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix
The Traceability Matrix in qmsWrapper™ is fully integrated into the project and quality management.
Audit Day Fears are Gone! How Cardio-Phoenix carried out of an ISO Audit With Help from qmsWrapper
Read about how Medical device startup "Cardio-Phoenix" successfully carried out the audit with help of qmsWrapper.
Choosing a QMS system? Why you should seriously look at the new qmsWrapper!
It’s a cloud-based development and compliance management software, in layman’s terms, a QMS and PM system specifically designed for meddev companies.
How to stay on top of your product development and easily organize your FDA and CE submission
The Traceability Matrix in qmsWrapper is fully integrated into the project and quality mngt. Map and Trace the design control relationships for your meddev.
Weekly Cup of Joe 29# – Customer Feedback is a Wealth of Information
Improve Customer Retention and Ensure That You Keep the Finger on the Pulse. Joe will guide you through ISO compliance
Pitfalls and Best Practices in Establishing a Quality Manual
This article includes what is a QM, and what should include, Common mistakes & how to avoid them, Pro tips & best practices on how to do it right ...
Weekly Cup of Joe #28 – Is Employee Training Worth the Investment?
Smart companies invest in the development of their employees.
QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
Ultimate Tips and Guidelines to Fine Tune Your Employee Trainings
By equipping employees with the tools and knowledge to perform their jobs, you can expect better performance and a more cohesive workplace.
10 Pitfalls and 13 Best Practices in Establishing a Quality Manual
The quality manual covers almost everything that the company and its employees need to know about the ISO standards and what is expected of your QMS.
Validating or Not Validating for Intended Use?
Learn more about pitfalls, what you should do and benefits of establishing the Validation for Intended Use Documentation
Weekly Cup of Joe #27 – Validating With The Wrong Requirements
Without specific parameters or with the wrong requirements, you might end up approving things that might turn out to be quite different from what you expected.
The Quality Manual F.A.Q. – Quality Manual Writing Tips
Tips and answers on how to effectively write Quality Manual for your company
Weekly Cup of Joe #26 – Advantages of An Integrated PM and QMS
Integrated PM and QM includes features such as QMS approval workflows, document history management, scheduling meetings, etc.
What if staying ISO and FDA compliant was easy?
A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more and sounds more, like FDA’s QSR.
The Quality Manual Alias the Quality Bible or the Quality DNA
Quality Manual is the foundation and framework from where you build your organisation. It is a plan, which sets the direction and navigates within the defined parameters.