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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…

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.

Not planning the work means you are constantly retracing your steps instead of moving from one area to the next, you waste time, make decisions on the fly.

As a newly minted QMS manager in a startup, I turned to the internet for what to do. I had to realize that today everybody is an internet certified QMS expert.

Productivity is all about efficiency -- doing more, faster and with less. A good quality management software can help you to get the most out of your day.

Document Management Softwares combine paper and digital files into a single hub. Here are few pain points which can be eliminated by using a DM Software.

Simply having a signed document is no longer the standard of proof. So how to prepare compliance documentation?

Risk management has become a separate branch of management science. But what is the difference between Risk and Uncertainty? How can we apply to a project?

The ongoing quest for compliance can sometimes be challenging when the needs are not always clear. How can a small team proceed when they are doing research?

There is a lot of information on the Web but it is not all very helpful. qmsJoe is here to guide you through the plethora of information and support you.

The ISO 13485 revision includes significant changes in a number of important areas. The following infographic offers a summary of these changes.