qmsWrapper Blog - Take Back Compliance - The Art of Managing Through Quality

If you have several different things that are pressing for your attention and you’re not sure how to prioritize and what to consider, read on.

The QMS documentation can be impenetrable. How to outsmart the system? In many cases a simple document management system won’t even do the expected job.

Good time management requires driving attention from activities to results: being busy isn’t the same as being effective.

The Quality Manual requires many references to the applied company and the workflow processes. Synchronously, most quality management related references are advising to

This question is a classic for a reason. Change anything in the Processes and your Quality Manual should be updated and vice versa.

Good QMS documentation is essential for an effective quality management system. Properly structured documentation will make your operations much easier.

Properly structured documentation will make your operations much easier, while incorrect documentation will bring you nothing but trouble.

Where to Start and what to do when you need to implement a QMS? The following 13 items will guide you. We will help you bootstrap your QMS efforts.

The Quality objectives are in the main focal point of any Quality policy. All the employees in the company should know how to achieve these objectives.

Where to Start and what to do when you need to implement a QMS? The following 13 items will guide you. We will help you bootstrap your QMS efforts.

In QMS it’s better to set accomplishable objectives and exceed the expectations, than to set unreachable objectives and fail to attain the calculation.

Where to Start and what to do when you need to implement a QMS? The following 13 items will guide you. We will help you bootstrap your QMS efforts.

QMS is vital in realizing Quality products customers want. They should listen to their customers... and include customer requirements…

Where to Start and what to do when you need to implement a QMS? The following 13 items will guide you. We will help you bootstrap your QMS efforts.

When hiring new people for specific job openings, usually we compare their skills and qualifications. Sometimes trainings are required to bridge the gap.

QMS and PM software are usually put together from series of APIs, they are disjointed and all together operate like Dr Frankenstein’s creation.

If you use wrong document or version, the whole effort would be in vain. Document Control softwares prevents users from using an obsolete or wrong document

nce a task has been assigned, ignoring it until it is done can lead to unexpected results. What’s in your head is not what’s in employee’s head.

Since developed by a medical device company, the priority was to design a QMS application that solves challenges facing medical device startups and companies.

If the requirement is not clear enough the employees make incorrect decisions related to the given task that might end in an unplanned surprise.

As regulatory and standards compliance increasingly play a critical role in business success, integrated compliance tools remain a sore point.

It is easier and cheaper to fix risks at the beginning of planning, rather than during production or worse, once the product is in use.

On Internet you can find hundreds of templates for ISO 13485, offered by consultants and experts. But it is not so certain that you will get what is promised

Resource management means monitoring and following the existing resources, balancing between the planned activities and the changing resource requirements.

In the world of regulations it is really easy to get confused. Processes and Workflows make sure that each step required to complete an action is completed.