Showing posts tagged with: qmsWrapper

Problems are always going to arise for any business no matter how hard you try to avoid them. While you can’t run a perfect business with all smooth situations, at qmsWrapper we can ensure friction doesn’t become an issue. You can always voice your challenges, we treat every issue as special, and not just another...

Audit – a word that inspires anxiety. Even when everything is well planned, and you think you are prepared, anticipation turns to anxiety, anxiety to fear, and fear to panic. There is no hiding anything in a remote closet or under the carpet. “Wherever you've hidden it, we'll find it.” Audit Senior It's an audit day! In the beginning,...

The new version of qmsWrapper is updated in December 2019. We were still shaking from a disastrous ISO audit. Joe, the perennial QMS manager from Jurassic times, just have been fired. Even though he liked pushing the paper-based system, a medical device company has too many regulatory pitfalls to trip you up. Brilliant engineers and developers just...

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...

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 include) Common mistakes in establishing a QM, and how to avoid them Pro...

Without proper employee training, business will likely see minimum success. Smart companies invest in the development of their employees. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.  Employee Training is deemed as the most important thing where the employees feel valued and develop an attachment to the overall mission of...

Tips and guidelines to create an efficient workforce and keep your business functioning at a high level. (ISO 9001, 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. Besides, the candidate’s adequate competency...

The most important part of the manual is the description of the QMS The quality manual provides a wide range of benefits for organizations. Besides, that is easy to follow, it covers almost everything that company and its employees need to know about the ISO standards and what is expected of your quality management system. A bad...

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...

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...

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. If you want...

Advantages in numbers 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,...

Small businesses typically face a struggle to succeed in a competitive MedDev 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,...

  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...

  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...

  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, 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...

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...

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,...

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...

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...

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...

It’s official, workplace emails are an ineffective tool for managing projects. Don’t confuse Emailing a link to your team as collaboration - that’s ping-pong! And sending your team an email and asking them to either comment or provide input on a file, an idea, a suggestion is like trying to push a wet string. Although email...

In a global environment, companies are facing countless complex, 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.     ISO certification, (be it ISO9001, ISO13485…)  communicates a commitment to quality to both customers and regulators. There are many benefits...

Software as an industry is unique in that not only can it be a product it can also be a service. Moreover, it is its own means of production;  Increasingly software can be found in all kinds of products, products that are ever more built to ISO standards, a.k.a. quality standards. And where quality and ISO...