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 company and its employees need to know about the ISO standards and what is expected of your quality management system.
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.
Are MedDev 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
qmsWrapper will secure cloud Quality& Project Management System solution to ensure up-time, diminish data loss, & maximise productivity ...
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 your company would like to achieve ISO 13485 certification,provide a clear picture of the organisations context to the auditors.
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.
Weekly Cup of Joe #19 –Projects in Wrong Place and Time
Few tips on Project requirements are one of the first things that have to be determined when starting a new project.
Advantages of Cloud Based QMS and Project Management Software
In this infographic, we present the actual percentages of the improvements your company can achieve with a cloud-based QMS or Project management software.
Cup of Joe 18# - Why is it Important to Select Your Suppliers Carefully
Select suppliers very carefully because the materials, parts and/or services provided by them have a significant impact on the product quality, and profitability.
ISO 13485 – 2016 Checklist
This Checklist will allow you to get more done, save time and reach your goals quicker.
The Purpose of a Quality Management System
The advantages to such integrated QMS systems is that ISO compliance is not limited to “reporting” or the tracking of reports to prove the quality, but rather is integrated into your workflow processes directly, so quality becomes everyone’s business throughout the workday.
Approval Workflows in QMS
QMS approval processes are supporting the accurate recording of acceptance or agreement in business documents.