Take Back Compliance
The Art of Managing Through Quality
The Quality Manual F.A.Q. – Quality Manual Writing Tips
Tips and answers on how to effectively write Quality Manual for your company
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.
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.
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.
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.
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. Synchronously, most quality management related references are advising to ...
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.
Project management and quality management 2017 - smart solution
QMS and PM software are usually put together from series of APIs, they are disjointed and all together operate like Dr Frankenstein’s creation.
The Dawn of Integrated QMS… Part 2
Since developed by a medical device company, the priority was to design a QMS application that solves challenges facing medical device startups and companies.
The Dawn of Integrated QMS… Part 1
As regulatory and standards compliance increasingly play a critical role in business success, integrated compliance tools remain a sore point.
The Temptation of ISO 13485 Template Kits
On Internet you can find hundreds of templates for ISO 13485, offered by consultants and experts. But it is not so certain that you will get what is promised
Same Tasks over and over Again? Let a Workflow Process Help You.
In the world of regulations it is really easy to get confused. Processes and Workflows make sure that each step required to complete an action is completed.
QMS Expert vs QMS Expert...alias - Today Everybody is an Internet Certified QMS Expert
As a newly minted QMS manager in a startup, I turned to the internet for what to do. I had to realize that today everybody is an internet certified QMS expert.
Top Documentation Pain Points Solved With DM Software
Document Management Softwares combine paper and digital files into a single hub. Here are few pain points which can be eliminated by using a DM Software.
Risk as synonymous with uncertainty?
Risk management has become a separate branch of management science. But what is the difference between Risk and Uncertainty? How can we apply to a project?
Chat for Compliance – a hacker’s view!
The ongoing quest for compliance can sometimes be challenging when the needs are not always clear. How can a small team proceed when they are doing research?
ISO 13485:2016 Summary
The ISO 13485 revision includes significant changes in a number of important areas. The following infographic offers a summary of these changes.
8 Secret Benefits of Using Team Collaboration Tools
Working in a team can be a challenge. Here are 8 typical annoying situations and the 8 Secret Benefits that you get by using Team Communication tools.