qmsWrapper Blog
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 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 most effective QMS system takes a more inclusive approach to business processes, combining ISO compliance with teamwork, workflows, doc. and project mngt.
Approval Workflows in QMS
QMS approval processes are supporting the accurate recording of acceptance or agreement in business documents.
Weekly Cup of Joe #17 –Don’t Buy Pig in a Poke!
Obtaining approval from a group of people for a project plan, a proposal or any required document is not something that should be done on an ad-hoc basis.
Weekly Cup of Joe #16 – Document Search Requirements in the QMS
qmsWrapper includes a full Document Mngt and Control functionality that provides full support for document search.
Balancing Priorities when everything is #1
Every given task needs to have a clear priority. In the medical device industry, when everything seems so important it is a must to ...
Documents in a Paperless Office, Find a Needle in the Haystack
The QMS documentation can be impenetrable. How to outsmart the system? In many cases a simple document management system won’t even do the expected job.
Where Did the Time Go? - Poor Time Management
Good time management requires driving attention from activities to results: being busy isn’t the same as being effective.
Quality Manual or Workflow Processes? What should I establish first?
The Quality Manual requires many references to the applied company and the workflow processes.
Weekly Cup of Joe #15 – Quality Manual or Company Processes / Chicken or The Egg
This question is a classic for a reason. Change anything in the Processes and your Quality Manual should be updated and vice versa.
QMS documentation - “What should I document?”
Good QMS documentation is essential for an effective quality management system. Properly structured documentation will make your operations much easier.
Weekly Cup of Joe #14 – QMS Documentation
Properly structured documentation will make your operations much easier, while incorrect documentation will bring you nothing but trouble.