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How many mandays are required for QMS audit?

SGquality

Quite Involved in Discussions
#1
In my Internal audit for ISO 13485, it is done by a single auditor for 4 days. If I compare this with the ISO type of calculation for mandays, does it fit ?

The plant I am referring to has around 700 employees and runs 24x7 all year round in 4 shifts. The annual turnover is about $100 million per year.

Would a 4 day audit be justified or do I have to increase the mandays ?
 
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#2
Re: How many mandays required for QMS audit ?

In my Internal audit for ISO 13485, it is done by a single auditor for 4 days. If I compare this with the ISO type of calculation for mandays, does it fit ?

The plant I am referring to has around 700 employees and runs 24x7 all year round in 4 shifts. The annual turnover is about $100 million per year.

Would a 4 day audit be justified or do I have to increase the mandays ?
It's hard to compare an internal audit with an external audit. You can find a document to provide guidance at www.iaf.nu. You'll need MD 5 and 9.

http://www.iaf.nu/upFiles/IAFMD92011ApplicationofISO17021inMDQMSIssue1v2Pub.pdf

From experience, unless you replicate the CB audits (which is not the function of an internal audit) the days really don't mean much in an internal audit programme.
 

SGquality

Quite Involved in Discussions
#3
Re: How many mandays required for QMS audit ?

Thanks Andy.

I had seen the MD9. While it says 15 days are required for Stage 1 + 2 audit, I was just trying to correlate internal audit mandays to this 15 days :)
 

John Broomfield

Staff member
Super Moderator
#4
Re: How many mandays required for QMS audit ?

Thanks Andy.

I had seen the MD9. While it says 15 days are required for Stage 1 + 2 audit, I was just trying to correlate internal audit mandays to this 15 days :)
SGquality,

The IAF Mandates are designed to stop accredited registrars from taking too small a sample of the system before declaring conformity for a "bargain" price!

For a second party system audit you could take 2/3rds of this time (10 auditor days) depending on the specific audit objectives.

But rarely are internal audits full system audits. If yours is one of these rare exceptions then why not plan the audit to fulfill its objective and then see if it can be completed in 10 auditor days?

My point is that the audit planning should determine the duration not the other way around.

John
 

SGquality

Quite Involved in Discussions
#5
Re: How many mandays required for QMS audit ?

SGquality,

The IAF Mandates are designed to stop accredited registrars from taking too small a sample of the system before declaring conformity for a "bargain" price!

For a second party system audit you could take 2/3rds of this time (10 auditor days) depending on the specific audit objectives.

But rarely are internal audits full system audits. If yours is one of these rare exceptions then why not plan the audit to fulfill its objective and then see if it can be completed in 10 auditor days?

My point is that the audit planning should determine the duration not the other way around.

John
Thanks John.

I totally agree with you but was thinking of using the IAF MD documents or equivalent guidelines to benchmark my mandays.

Our internal audits are also quite rigorous and dwelve deep into the QS requirements. Would there be any other mechanism to measure the mandays required for internal audit ?

This info is also from the view that most of our plants resist to 4 days and say why not 2 days or 3 days ... so wanted to use something well documented as a tool to justify.

Thank you all :thanx:
 
#6
SG:
Why not break down you audits into smaller, more focused audits in areas which have "status and importance"? It sounds as if you are emulating the CB audits and therein lies the issue. Too much is being taken on, instead of small, more manageable, scopes.
 
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