Showing posts tagged with: FDA510(k)

10 Pitfalls and 13 Best Practices in Establishing a Quality Manual
It takes the same amount of time and effort to create a good quality manual as it does a bad one.
A bad quality manual that nobody reads or uses is a common mistake. Yet, customers judge you by it, ISO auditors start with it, and your own employees, should refer to it for everyday guidance...

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.
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