Let’s first define what is change — a change is any modification to an element in the QMS or to a combination of several elements that may affect the quality of the product or the service. There are numerous events and files that are subject to change in the quality…

Someone phrased it very well and said that implementing a quality management system is as much an art as it is a science. It involves a bunch of data, but also requires the ability to engage people. It takes the systemized approach, but also requires creativity for a complete picture.

What does it take to implement QMS?

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In one of our previous articles we have introduced you to one of our features that enormously can help you stay in touch with your team while working at home during this COVID crisis, but at the same time maintain your QMS. …

Well, Capterra, the well known and reliable website for software reviews says that Quality Management Software pricing starts at $1500.00 per month. But that information is too general because it does not give you information on how many users are included in the price, are the training sessions included, or…

This cycle or as others naming it a method, which is not a mistake, is one of the most vital quality improvement tools.

If you are wondering should you use it or not, keep in mind the ISO 9001 Standard highly encourages its use, so as we. Because if you…

If you think about what it takes to bring a medical device to the market, there are several phases that you go through. Usually, it starts with the project plan that specifies tasks that must be completed to get your product to market. …

QMS standards are based on the process approach. Any activity that is receives input and converts it to output can be considered as a process. In order to company function effectively, it should identify and manage linked processes (nonconformity reporting, CAPA, audit management, etc.).

It’s all connected

Systems consist of processes, and processes…

qmsWrapper is an interconnected Quality Management software for companies focused on regulatory issues, and quality requirements specific to these companies. qmsWrapper provides the means for teams to work effectively together, integrating Team Communication, Quality Management, Documentation, and Project Management, all built right into its DNA.

All this functionality is unified…