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 management system. For example, customer feedback and complaints, product failure, determining risk, internal audit results, etc.

The quality management system faces various changes during the lifecycle of your product regularly. And the point here is to handle that change effectively because it’s one of the most important functions in QMS…

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?

It takes people, decisions, resources, and budget. But on the other hand, to implement it you will need a quality manual, policy, procedures, work instructions, lists, checklists, forms.

OK, so let’s say you want to implement a quality management system because you want to be organized better or you might…

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. But we couldn’t help but wonder if you are aware, how good and affordable QMS software can help you save your business, at these rough times.

If you didn’t know, QMS implementation could do more for your company than just control quality. Besides giving you a structured approach to managing your business, it also creates benefits as managing…

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 templates or storage, or does it have all the modules and features your company needs, or is there an add-on option that is at an additional cost?

To see the true value for the price you pay, all these answers must be throughout covered. Does that selected QMS software really…

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 apply it, it’s expected from you to apply it across the range of processes involved in any quality system. And application takes a range from planning for quality and review of performance, through to taking effective action to respond to, and resolve, weaknesses in the system (CAPA).

Prevent a fail with PDSA

You cannot fail…

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. You then develop specifications and make any number of things.

Getting to market also includes being compliant with ISO 13485, which is a global standard for Quality Management System that is voluntary in the US but required in some countries. In the US are most of the requirements similar to the whole world. For example: To comply…

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 are made up of tasks. When scheming and implementing a QMS, this hierarchy of systems, processes, and tasks is important to help deploy an effective and compliant QMS.

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 in one platform, no API’s to integrate or frustrate. Deployment is smoother… Startups, creative teams, mature organizations, and quality-oriented teams will find qmsWrapper the right approach to achieving painless compliance.

Why is qmsWrapper better than other available QMS software?