R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Internal Audits, the After-Thought of a Quality System

Why is it that Internal Audits are forgotten, or even worse feared? Why is it so many organizations of today place so much focus on the creation of Quality Procedures, Work Instructions, Forms, etc. but do not place the same focus on conducting internal audits of the quality system? Is it human nature? We all tend to be "gung-ho" about projects at the start, but the passion, and therefore the quality of the work, so often deteriorates over time.

Thoughts About Auditing

'Tis the season for auditing. The beginning of this year, just like years in the past, seems to have brought the New Year's Resolution that audits will be scheduled and conducted to correct the sins of the previous year and take a fresh look at the upcoming year. To this point I've conducted three audits and after this week I'll have been the auditee twice (essentially an audit per week to start the year).

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