qmsWrapper Blog - Take Back Compliance - The Art of Managing Through Quality
Gone! Audit Day Fears! How Cardio-Phoenix Took the Fear out of an ISO Audit With Help from qmsWrapper
Audit – a word that inspires anxiety. Even when everything is well planned, and you think you are prepared, anticipation turns to anxiety, anxiety to fear, and fear to panic. There is no hiding anything in a remote closet or under the carpet.
“Wherever you've hidden it, we'll find it.”
Audit Senior
It's audit day!
Turning anxiety into joy!
The...
How to stay on top of your product development and easily organize your FDA and CE submission
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Weekly Cup of Joe 29# – Customer Feedback is a Wealth of Information
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight.
Pitfalls and Best Practices in Establishing a Quality Manual
It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less...
Weekly Cup of Joe #28 – Is Employee Training Worth the Investment?
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight.
Ultimate Tips and Guidelines to Fine Tune Your Employee Trainings
Nobody wants to hire a person that is unable to do a job to a satisfactory standard. This is especially true when it comes to QMS related functions and activities.
10 Pitfalls and 13 Best Practices in Establishing a Quality Manual
It takes the same amount of time and effort to create a good quality manual as it does a bad one.
Validating or Not Validating for Intended Use?
When I say Validation For Intended Use, most of you picture an extensive documentation required by ISO and FDA.
Although Validation for intended use documentation is useful for several reasons.
Weekly Cup of Joe #27 – Validating With The Wrong Requirements
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight.
The Quality Manual F.A.Q. – Quality Manual Writing Tips
To pass a certification body audit, a Quality Management System must be an auditable entity with a neat Quality Manual.
Weekly Cup of Joe #26 – Advantages of An Integrated PM and QMS
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight.
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 organization. It is a plan, which sets the direction and navigates the organization within the defined parameters.
Are companies ready for the ISO 13485:2016? “a closer look”
This is a real and topical question. At every MedDev or MedTec oriented exhibition this is the off-stage topic, actually more like main grippe session.
Do you know how secure your documents really are?
The following infographic will help you recognize the primary causes and warning signs for potential data loss and the top tips for prevention.
Weekly Cup of Joe #25– Documenting Opportunities to Improve
Documenting improvements are more important that the ideas itself because an idea that is not documented, does not exist.
Weekly Cup of Joe #24 - Data Backup and Recovery Plan in QMS
Typically, small businesses don’t invest in a data backup and recovery plan in place, because they’re unclear about the true value of such solutions.
Weekly Cup of Joe #23– Corrective and Preventive Action (CAPA)
Ignoring preventive actions might sound like saving money at first, but not investing resources into improving processes will cost more on a long term.
Weekly Cup of Joe #22 – Risk Management Strategy in QMS
Your risk controls will have a direct impact on your design outputs. An inappropriate risk management strategy will lead to incorrect hazard evaluation.
Hidden Pitfalls in the Risk Management Strategy
Risk management is one of the key factors in quality management. Effectively managed risks help companies achieve their goals.
Weekly Cup of Joe #21 – References on Obsolete QMS Documents
Company policies should include and cover managing, identifying and updating all the documents that contain references to obsolete versions or documents.
ISO Audit and the Company Image
If the company is not aware of its context, then that could lead to some real pitfalls since that means there is no real picture.
ISO 9001 – 2015 Checklist
If you do QMS right, it’s not a burden, not an added layer of management that gets in the way. The following checklist will guide you.