Showing posts tagged with: Quality Manual
A new Traceability Matrix so powerful, it becomes the products dashboard
TM is now more effective and useful feature that serves as a dashboard for product development leading to submission.
You build your Traceability Matrix as you develop your product...
Key functions of qmsWrapper Traceability Matrix:
track and show the relationships and connections between requirements
end to end traceability
design controls, by column
tracking number automatically assigned and inherited
export into a print-ready...
Audit Day Fears are Gone! How Cardio-Phoenix carried out of an ISO Audit With Help from qmsWrapper
Audit – a word that inspires anxiety. Even when everything is well planned, and you think you are prepared, anticipation turns to anxiety, anxiety to fear, and fear to panic. There is no hiding anything in a remote closet or under the carpet.
“Wherever you've hidden it, we'll find it.”
Audit Senior
It's an audit day!
In the beginning,...
10 Pitfalls and 13 Best Practices in Establishing a Quality Manual
The most important part of the manual is the description of the QMS
The quality manual provides a wide range of benefits for organizations. Besides, that is easy to follow, it covers almost everything that company and its employees need to know about the ISO standards and what is expected of your quality management system.
A bad...
The Quality Manual F.A.Q. – Quality Manual Writing Tips
To pass a certification body audit, a Quality Management System must be an auditable entity with a neat Quality Manual.
How to get useful ‘written stuff’?
For hints on what to do, see the Quality manual writing tips part 2, in this short and clear infographic we collected 13 of the top F.A.Q.s and answers.
If you want...
The Quality Manual Alias the Quality Bible or the Quality DNA
Document what you do and do what you document
Quality Manual is the foundation and framework from where you build your organization. It is a plan, which sets the direction and navigates the organization within the defined parameters. Like any plan, it is good to revisit once in a while and check against the agreed objectives,...
Quality Manual or Workflow Processes? What should I establish first?
So, what documentation hierarchy should we adopt?
It turns out that this question is a classic for a reason. People have been asking it for many years, and there is more than a little confusion on the answer.
The Quality Manual requires many references to the applied company and the workflow processes. Synchronously, most quality management related...
Weekly Cup of Joe #15 – Quality Manual or Company Processes / Chicken or The Egg
Whether you are freshly minted into the QMS position or you are a founder of a Startup or a product manager with a new project… your strategy requires QMS oversight.
QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
So, what documentation hierarchy should we adopt?
This question is a...