qmsWrapper Blog - Take Back Compliance - The Art of Managing Through Quality
QMS for Beginners – A quick guide on where to Start ! …Part 1
Where to Start and what to do when you need to implement a QMS? The following 13 items will guide you. We will help you bootstrap your QMS efforts.
Weekly Cup of Joe #10 – Appropriate training of new employees
When hiring new people for specific job openings, usually we compare their skills and qualifications. Sometimes trainings are required to bridge the gap.
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.
Weekly Cup of Joe #9 – Improper document, wrong results
If you use wrong document or version, the whole effort would be in vain. Document Control softwares prevents users from using an obsolete or wrong document
Weekly Cup of Joe #8 – Ineffective task monitoring
nce a task has been assigned, ignoring it until it is done can lead to unexpected results. What’s in your head is not what’s in employee’s head.
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.
Weekly Cup of Joe #7 - Vague wording
If the requirement is not clear enough the employees make incorrect decisions related to the given task that might end in an unplanned surprise.
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.
Weekly Cup of Joe #6 – Identifying potential hazards
It is easier and cheaper to fix risks at the beginning of planning, rather than during production or worse, once the product is in use.
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
Weekly Cup of Joe #5 – Incorrect Resource Management
Resource management means monitoring and following the existing resources, balancing between the planned activities and the changing resource requirements.
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.
Weekly Cup of Joe # 4 – Quality Planning
Not planning the work means you are constantly retracing your steps instead of moving from one area to the next, you waste time, make decisions on the fly.
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.
Weekly Cup of Joe #3
Productivity is all about efficiency -- doing more, faster and with less. A good quality management software can help you to get the most out of your day.
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.
Weekly cup of Joe #2 - Documenting Compliance
It is not enough to complete a signed QMS form saying the action was completed, any lack of documentation means that they never happened, signed form or not
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?
Weekly Cup of Joe #1
There is a lot of information on the Web but it is not all very helpful. qmsJoe is here to guide you through the plethora of information and support you.
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.
New Feature Announcement: "My Team", for qmsWrapper
“My Team” is a new module that gives managers the ability to track and monitor overall team progress and productivity, from individuals to the entire team.
Design Methodology Process - the guide through compliant design change
So you want to design a new version of your medical device? Here’s what you need to do to ensure ISO and FDA compliance.
Management Through Quality, documenting compliance activities
Most QMS systems are form driven. Do an action, fill-a-form, make a meeting... The list is endless and if you forget, then your QMS system has holes.