Learn about Templates for ISO 13485:2016

Every beginning is hard, and implementing a Quality Management System for medical devices can be hard work too. Particularly if you are doing it on your own, without the help of a consultant. Imagine having included in your QMS software a premade form that you just have to fill up with data from your organization and done. Chances for mistakes are taken to zero. That’s why templates are the perfect way to get you off the ground.

Benefits of having templates:

Templates are an approach to build a foundation at a medical device organization. Templates can form a fast-start baseline to a QMS.

They allow you to create your workspace using a predesigned format or structure. Point is that using templates encourage repeatability and efficiency.

There are several reasons for you to use templates:

· It will help you to set up a solid base

· Easy to follow guidance built-in

· Ease the documentation process

Making templates — build and design forms

Nowadays, there is much software providing DIY templates. Custom templates are now new state of art. For example, you need Quality Manual, it’s required if you are aiming for ISO 13485 certification.

Clearly, if you are a start-up, you have no idea where to start from, or maybe even how it should look like. Then imagine, having a defined structure already built is extremely time-saving. Only qmsWrapper, QMS software for medical devices, is providing this addition with its license purchase.

QMS TEMPLATES AIM TO HELP YOU MAKE IMPLEMENTATION FASTER AND EASIER FOR YOU.

In the medical device industry, templates are mostly used for developing policies, SOPs, and work instructions, then for recording certain QMS events — conducted CAPAs, performed training, validation of processes, etc. These areas are set out as being essential components of a medical device quality management system by the various regulatory bodies.

That’s why there is software like qmsWrapper to help you implement and maintain your QMS while staying compliant. With qmsWrapper, you will be capable to properly organize and structure the applicable processes and to guide you throughout messy data of QMS implementation and maintenance. You will achieve consistency and clarity, plus you can save time and money.

Conclusion:

qmsWrapper has recognized the need for customizable templates and made it part of the package.

Using the templates through the implementation and maintenance of your QMS will help you meet EU MDR and FDA requirements. Besides, it will help you simplify document creation, building your procedures, establish your SOP…