Showing posts tagged with: QMS

  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...

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 is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...

  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....

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 is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...

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...

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 is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...

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...

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 is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...

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 is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...

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,...

Vague wording used in requirement documents 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 is here to guide you through the plethora of information and support you with handy tips & tricks...

Making the life of a startup easier As regulatory and standards compliance increasingly play a critical role in business success, integrated compliance tools remain a sore point. QMS systems are too often based on PDF documents being generated at the right time. The challenge for the user is knowing when that time is, and what form...

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 is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...

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...

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 is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...

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...

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 is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...

  The newbie QMS Managers Conundrum – 5 things to identify the right Expert? As a newly minted QMS manager in a medical device startup, I turned to the internet for what to do. Soon I had to realize that today everybody is an internet certified QMS expert. There was information galore, in fact so much 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. qmsJoe is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to compliance. Simply...

  ” Risk /rɪsk/, noun the possibility that something unpleasant or unwelcome will happen. Synonyms: chance, uncertainty, unpredictability, instability, riskiness…”   We’re dealing with countless risks in our daily life, like getting cut during apple slicing, or catching a cold if we get wet on a rainy day…or planning a project without a proper risk management plan…  Unknowingly you are doing...

This week we bring you a real-life experience example about how the qmsWrapper built-in chat function can turn the compliance documenting process into an easily manageable one. The ongoing quest for compliance can sometimes be challenging when the needs are not always clear. For example, developing new software is straightforward, customer needs or use cases, requirements, specification, test...

What's the first step towards FDA or ISO compliance?  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 and you have several questions like “where to start” and “what to do”. There is a lot of...

Medical Devices – Quality Management System – Requirements for Regulatory Purposes   The world’s most popular standard for medical device quality management has been revised for the first time since 2003: Medical Devices – Quality Management System – Requirements for Regulatory Purposes. The revised standard ISO 13485:2016 was published on 1st March 2016. It focuses on how companies...

  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. As a medical device design engineer, you know every part of your design; you know how all the pieces fit together and how they are built and their purpose. Sadly, it also...

QMS, another layer of management or smart management.  If you’re thinking that a QMS system would be just another layer of management, think again! It’s true that most QMS systems are form-driven. Do an action, fill-a-form. Make a meeting, fill-a-form? The list is endless and if you forget, which is easy to do when deadlines are knocking...