Showing posts tagged with: qmsWrapper
Cup of Joe #46 - New superpower for MedDev through qmsWrappers TM
Last week qmsWrapper announced the greatest upgrade of the year. New updates are Integration with Jira Software, updated Risk Module, and Process Engine and, best for the last - upgraded Traceability Matrix!
Joe will introduce you to the first one of the super upgraded Traceability Matrix.
Traceability Matrix with an issue
Working in TM in the past had a...
Cup of Joe 43# - Treat the cause, not the symptom
What is the root cause analysis?
Root Cause Analysis is something that we all do when we want to solve a problem for good.
But what RCA actually means?
It means to find what caused the problem, to find out not only what went wrong in the beginning, but how, when and why as well.
Basically, RCA is...
Cup of Joe 40# - Documents and procedures amendment
It's one thing to become ISO certified, but maintaining the certification is another thing with all the updates and new records.
Besides following the processes and procedures that were set, it's also required to improve processes and all recorded as evidence. That means keeping up with your documentation, updating procedures when the processes change, modify work...
Cup of Joe 37# - Why we have to perform an audit?
At work, nothing raises the hairs on the back of your neck like the word “audit”.
Audits mean fault, mistake, short-coming and blame, fault, culpability all wrapped in disappointment – you have failed! The bullies incorporate love them! But the wise manager embraced them and uses them to pre-empt the bullies, by self-auditing.
The more positive...
Cup of Joe 35# - Signing your electronic documents
One of the main criteria for an eQMS is to have implemented an electronic signature.
Many eQMS software have found many ways to handle this issue, but they all have to satisfy 21 CFR part 11. This part clearly paraphrases the fundamental rules of electronic signature implementation and control for compliance needs.
When we are talking about...
Cup of Joe 34# - How to organize your folders?
Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS. Where is this file? Is it under review? Is this draft version? Is it approved? The need to check it and review it, then approve can take time and mistakes can be weird...
Weekly Cup of Joe 29# – Customer Feedback is a Wealth of Information
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight.
QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
Improve Customer Retention and Ensure That You Keep the Finger on...
Pitfalls and Best Practices in Establishing a Quality Manual
It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less...
In this article, we will discuss how to establish, operate and maintain a good one:
Introduction (what is a QM, and what should it include)
Common mistakes in establishing a QM, and how to...
Weekly Cup of Joe #28 – Is Employee Training Worth the Investment?
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight.
QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
Convert Employee Training into the Workplace
Don't try to save money on...
Ultimate Tips and Guidelines to Fine Tune Your Employee Trainings
Tips and guidelines to create an efficient workforce and keep your business functioning at a high level. (ISO 90001, ISO13485, FDA510K)
Nobody wants to hire a person that is unable to do a job to a satisfactory standard. This is especially true when it comes to QMS related functions and activities. Beside the candidate’s adequate competency...
10 Pitfalls and 13 Best Practices in Establishing a Quality Manual
It takes the same amount of time and effort to create a good quality manual as it does a bad one.
A bad quality manual that nobody reads or uses is a common mistake. Yet, customers judge you by it, ISO auditors start with it, and your own employees, should refer to it for everyday guidance...
Validating or Not Validating for Intended Use?
When I say Validation For Intended Use, most of you picture an extensive documentation required by ISO and FDA.
Although Validation for intended use documentation is useful for several reasons (ensure accuracy, reliability, consistent intended performance, the ability to discern invalid or altered records, etc.) people mainly think of it as a regulatory requirement only.
In FDA's...
Weekly Cup of Joe #27 – Validating With The Wrong Requirements
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight.
QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
Validating your system for FDA and ISO
Both FDA and ISO13485...
The Quality Manual F.A.Q. – Quality Manual Writing Tips
To pass a certification body audit, a Quality Management System must be an auditable entity with a neat Quality Manual.
How to get useful ‘written stuff’?
For hints on what to do, see the Quality manual writing tips part 2, in this short and clear infographic we collected 13 of the top F.A.Q.s and answers.
See Full Size
Advantages of Cloud Based QMS and Project Management Software
Every industry or organization is working hard to achieve success and to ensure their service and product safety. Nowadays, it is hard to imagine the work without an electronic, cloud-based QMS or project management tool.
Cloud based tools are the most searched software today, they are easy to obtain through the internet, they are flexible, they...
The Purpose of a Quality Management System
Small businesses typically face a struggle to succeed in a competitive marketplace. Companies that offer quality services or products are better positioned to not only survive but prosper. A well-managed QMS is paramount to success.
What is a good Quality Management System?
QMS systems come in all flavors and shapes, some are industry specific, others more general,...
QMS for Beginners – A quick guide on where to Start ! …Part 4
12. Customer Support and Life Cycle management
Customer support is not the issue at this time. You need to develop and finish your product first, then get it cleared through FDA and CE Approved. You need a system that’s focused on those issues. Don’t get confused by these future requirements. There is time enough to figure...
QMS for Beginners – A quick guide on where to Start ! …Part 3
The 13 items that will guide you through the implementation of QMS ...Let's pick up where we left off !
8. Selecting the right system to support your Compliance
Compliance Solutions are essentially QMS based solutions. They come in all shapes and sizes. Some solutions, such as ZenQMS are nothing more than forms tacked on to a project management...
QMS for Beginners – A quick guide on where to Start ! …Part 2
The 13 items that will guide you through the implementation of QMS - continues...
4. Organizing the work
Next you will need to define the flow of how work gets done within your organization, i.e. the workflows. Why, because you need to understand where compliance issues will fit in. Workflows can show you the path tasks take through your organization… i.e....
QMS for Beginners – A quick guide on where to Start ! …Part 1
Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project, you’re reading this because your strategy requires QMS oversight and your first question is likely “where to start” and “what to do”.
We could squeeze in 5 main points the initial...
Project management and quality management 2017 - smart solution
qmsWrapper is 1 system with 5 modules
and if you thought project management couldn't include QMS... think again...
In a global environment, companies are facing countless complex and unique industry challenges. Quality becomes not just a buzzword but a true competitive advantage – companies that deliver the best quality products and services efficiently - succeed.
Today’s QMS and...
The Dawn of Integrated QMS… Part 2
qmsWrapper, the leading integrated QMS system specifically aimed at compliance
qmsWrapper has Compliance in its DNA.
Since developed by a medical device company, the priority was to design a QMS application that solves many challenges facing medical device startups and small companies. Based on Project, Quality, Risk, and Document Management with a truly comprehensive Team messaging. In qmsWrapper,...
The Temptation of ISO 13485 Template Kits
Be careful what you use when building up your QMS system!
The expanding Internet means more: more data, more collaboration, and more complex systems of interactions. You can find hundreds of both expensive and free templates for ISO 13485, offered by various consultants, companies and experts. But even if the ISO compliance is guaranteed on some...
Same Tasks over and over Again? Let a Workflow Process Help You.
In the world of standards, regulations and protocols it is really easy to get confused. They are complex and always changing. Often, the issue is in the details and details are easily missed. Then when you try to make things compliant, you have to constantly be on top of every little detail if you don't...
New Feature Announcement: "My Team", for qmsWrapper
We are pleased to announce the release of the new team managing tool - My Team, in the Project Management Module for qmsWrapper.
Projects are about teams, but the biggest project of all is managing your team.
Announcing “My Team”, the newest element of qmsWrapper.
“My Team” is a new module that gives managers the ability to...
