L
Lismarie - 2009
I'm wondering if anyone have used a scoring system for internal audits based on ISO 13485, taking into account the severity of the non-conformances (i.e. critical, major, minor)
Thanks!!
Thanks!!
I'm wondering if anyone have used a scoring system for internal audits based on ISO 13485, taking into account the severity of the non-conformances (i.e. critical, major, minor)
Thanks!!
I am not familier with ISO 13485 so I cannot speak to that specific set of requirements. I can however share with you a technique I successfully used in the past for reporting audit results and subsequent improvement or deterioration of the QMS.
The basic concept involves the metric of average Deficiencies/Audit. There are a number of factors to consider when utilizing this approach such as system maturity, experience and capability of audit staff, quality of audit checklists, and the severity level of the findings themselves.
If you are interested in knowing more, contact me via email and I can share more detail with you.
Bob
For those of you who have developed a scoring system, can I ask a fundamental question?
What purpose does placing a numerical value on an audit finding accomplish?