C
cartman1417
Hello Experts,
Some of you might recognize me from my recent posts. I have a silly question now.
What is an audit? audit system? internal audit system? etc.
Background: We are a new 2 person medical device company. I am the QA/Manufacturing/Engineering director (believe it or not!). We are starting to setup QMS and make our way to get the product CE Marking.
I've established the quality manual and a lot of procedures and forms. A few are remaining. Now I am at the 822 - Internal Audit procedure and I don't understand what it is?
I looked at other threads in this forum, but it keeps on confusing me
Can someone please explain in plain English what audit is all about and what's the process to get it done? audit system, internal audit system, internal audit, external audit, who does what, should i take internal audit course, etc.
Thanks in advance!
Some of you might recognize me from my recent posts. I have a silly question now.
What is an audit? audit system? internal audit system? etc.
Background: We are a new 2 person medical device company. I am the QA/Manufacturing/Engineering director (believe it or not!). We are starting to setup QMS and make our way to get the product CE Marking.
I've established the quality manual and a lot of procedures and forms. A few are remaining. Now I am at the 822 - Internal Audit procedure and I don't understand what it is?
I looked at other threads in this forum, but it keeps on confusing me
When I did internal audits I audited the internal audit system. I was not responsible for the audit system, only for the internal audit I did.
What I did do was require someone from the company to go over my internal audit and do a writeup (audit, if you will) of my audit to verify that I did the internal audit according to the system. The person who reviewed my internal audit was the person who was responsible for the internal audit system.
Can someone please explain in plain English what audit is all about and what's the process to get it done? audit system, internal audit system, internal audit, external audit, who does what, should i take internal audit course, etc.
Thanks in advance!
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