qmsWrapper Blog

Tips and answers on how to effectively write Quality Manual for your company

Integrated PM and QM includes features such as QMS approval workflows, document history management, scheduling meetings, etc.

A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more and sounds more, like FDA’s QSR.

Quality Manual is the foundation and framework from where you build your organisation. It is a plan, which sets the direction and navigates within the defined parameters.

This is a real and topical question. At every MedDev or MedTec oriented exhibition this is the off-stage topic, actually more like main grippe session.

The following infographic will help you recognize the primary causes and warning signs for potential data loss and the top tips for prevention.

Documenting improvements are more important that the ideas itself because an idea that is not documented, does not exist.

qmsWrapper will secure cloud Quality& Project Management System solution to ensure up-time, diminish data loss, & maximise productivity ...

Ignoring preventive actions might sound like saving money at first, but not investing resources into improving processes will cost more on a long term.

Your risk controls will have a direct impact on your design outputs. An inappropriate risk management strategy will lead to incorrect hazard evaluation.

Risk management is one of the key factors in quality management. Effectively managed risks help companies achieve their goals.

Company policies should include and cover managing, identifying and updating all the documents that contain references to obsolete versions or documents.

If your company would like to achieve ISO 13485 certification,provide a clear picture of the organisations context to the auditors.

If you do QMS right, it’s not a burden, not an added layer of management that gets in the way. The following checklist will guide you.

Few tips on Project requirements are one of the first things that have to be determined when starting a new project.

In this infographic, we present the actual percentages of the improvements your company can achieve with a cloud-based QMS or Project management software.

Select suppliers very carefully because the materials, parts, and/or services provided by them have a significant impact on product quality, and profitability.

This Checklist will allow you to get more done, save time and reach your goals quicker.

The most effective QMS system takes a more inclusive approach to business processes, combining ISO compliance with teamwork, workflows, doc. and project mngt.

QMS approval processes are supporting the accurate recording of acceptance or agreement in business documents.

Obtaining approval from a group of people for a project plan, a proposal or any required document is not something that should be done on an ad-hoc basis.

qmsWrapper includes a full Document Mngt and Control functionality that provides full support for document search.

Every given task needs to have a clear priority. In the medical device industry, when everything seems so important it is a must to ...

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.