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Sample Questions for Auditing Management Rep , Internal Audit and Reg. Compliance

kuyakut

Involved In Discussions
#1
Hi Guys,

I was task to audit this 3 areas , Management Rep , Internal Audit and Reg Compliance (ISO 9001:2000 and ISO 13485 ). I undergone Internal Quality Auditing Course 5 years ago. Three (3) of our employee left , and this 3 personnel also are certified internal quality auditor in our company. Now the internal quality audit is schedule on 2nd week of Feb 2012. Since I undergone internal quality course , the MR rope me to help audit 3 areas. I was in a delimna because I haven't done auditing for the past 3 years. I'm just asking some little help from this furom ,if anyone of you have some questionaire pertaining to Management Rep, Internal Quality Audit and Regulatory Compliancen auditing . With my limited time and busy schedule , I dony know if I am able to audit properly. Right now I started reading ISO 9001 and ISO 13485 standards during my free time.

Any help would be greatly appreciated.


Thanks,

KUYAKUT
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Do you have a list of their procedures/processes? If not, get copies and audit using them since it's an internal audit.

Or is this intended to be a "compliance to the standard" audit?
 

kuyakut

Involved In Discussions
#3
Hi Marc,

I' m asking the Doc Control to furnish me the procedure relating to MR , Internal Audit and RC .
Its an internal audit at the same time a prelude to our recertification audit. Three weeks after the Internal Audit we will be having our recertification for ISO 9001 and ISO13485. I have gotten some few pointers in some of the post in the Internal Auditing forum.


Thanks,

KUYAKUT
 
C

Chance

#4
Kuyakut,

As Marc said, get copies of those procedures and audit them. Make sure that what is written in those procedures is actually done. If the procedure says "record something", ask for proof of evidence. If it does not satisfy to what is written in the procedure then take note and report them.

Let us know if you need anything else.
 

kuyakut

Involved In Discussions
#5
Hi Chance,

Thanks for the comment, I'm starting to compile all the procedures and documents pertaining to the areas that will be audited. Kinda start reading some of the procedures and taking notes .


Thanks,

Kuyakut
 

Randy

Super Moderator
#6
Well 1st of all you're auditing the wrong thing, you don't audit people, you audit the system that people are a part of and meet their defined responsibilities within.

Look at the process, not the person
 
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