qmsWrapper Blog - Take Back Compliance - The Art of Managing Through Quality
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.
Weekly Cup of Joe #19 –Projects in Wrong Place and Time
Project requirements are one of the first things that have to be determined when starting a new project. Sometimes it might be quite challenging.
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.
Why is it Important to Select Your Suppliers Carefully
Select suppliers very carefully because the materials, parts and or services provided by them have significant impact on the product quality.
ISO 13485 – 2016 Checklist
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager, the following checklist will guide you.
The Purpose of a Quality Management System
Small businesses typically face a struggle to succeed in a competitive marketplace. Companies that offer quality services are better positioned to prosper.
Approval Workflows in QMS
Maintaining compliance is not an easy job. 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
Chasing document traceability can be a really tangled mess. A poorly designed Document Control software can cause confusion and generate a lot of extra work
Balancing Priorities when everything is #1
If you have several different things that are pressing for your attention and you’re not sure how to prioritize and what to consider, read on.
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. Synchronously, most quality management related references are advising to
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.