IAF-MD9 Audit Man-Days Requirements for ISO 13485

M

MantleMickey

#1
#1
Hello,
Did anyone else get the memo on this mandate?
I am in the middle of an ISO 13485 audit, for 3 days duration, and they tell me now I have to go 6 days duration.

Does anyone else have this problem? We have 29 people, and that equals 6 audit days now!

Any comments?
:thanx:
 
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M

MantleMickey

#3
#3
Re: New regulatory requirement IAF-MD9

Thanks for the followup. I do have that standard, but does it apply to me,
since I'm in the middle of a certification audit and have had a pre-assessment audit?
Why should a sub-contractor, making products per customer specification, be required to be audited the same amount of days as a design manufacturer?
It doesn't make sense to me. Any other comments, or have any more of you had to double your audit days due to this new requirement?
 
Randy

Randy

Super Moderator
#4
#4
Re: New regulatory requirement IAF-MD9

MantleMickey said:
Thanks for the followup. I do have that standard, but does it apply to me,
since I'm in the middle of a certification audit and have had a pre-assessment audit?
Why should a sub-contractor, making products per customer specification, be required to be audited the same amount of days as a design manufacturer?
It doesn't make sense to me. Any other comments, or have any more of you had to double your audit days due to this new requirement?
Click to expand...
Does it apply to you? Nope, it applies to the organization performing the audit " This document is mandatory for the consistent application of Clause 9.1.4. of ISO/IEC 17021:2006 for audits of quality and environmental management systems and is based upon guidance previously provided
in IAF GD2:2005 Annex 2 and GD6: 2006 Annex 1. "

Why should a sub-contractor, making products per customer specification, be required to be audited the same amount of days as a design manufacturer?
Click to expand...
Because the certification is for you, not the other guy.

And it's not a new requirement, MD 5 has been around for quite some time, as with other documents it is occasionally revised.
 
M

MantleMickey

#5
#5
Re: New regulatory requirement IAF-MD9

Thanks Randy,
But the registrar performing our certification audit says we need to now
have 6 audit days, instead of the 3 days they quoted.
Do I have any authority over this change by the auditor?
We had a signed agreement, 29 people, 3 day audit,
with certification to ISO 13485.
Thanks for any assistance.
 
L

lamorenita_QA

#6
#6
Re: New IAF-MD9 Regulatory Audit Man-Days Requirement

MantleMickey said:
Hello,
Did anyone else get the memo on this mandate?
I am in the middle of an ISO 13485 audit, for 3 days duration, and they tell me now I have to go 6 days duration.

Does anyone else have this problem? We have 29 people, and that equals 6 audit days now!

Any comments?
:thanx:
Click to expand...
Hi,IAF mdatory Doc for the application of ISO/IEC 17021 In Medical device QMS (ISO 13485). This is required now for all CB's, Annex D list a table for auditing duration and contains a list of factors which may increase or reduce the auditing duration. this went into effect last month. We just went thru our re-certification audit 13485 9001:2008. this took 4 days, but this annex now lists a auditing duration (for our size of company) of 11 days. Can someone provide any feedback, am I reading this correctly?
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Leader
Admin
#7
#7
Re: New IAF-MD9 Regulatory Audit Man-Days Requirement

lamorenita_QA said:
Can someone provide any feedback, am I reading this correctly?
Click to expand...
The table in annex D of the IAF MD9 document is for Initial Audits (stage 1 and 2). A recertification audit would typically last [sup]2[/sup]/[sub]3[/sub] of the Initial Audit duration.
 
Randy

Randy

Super Moderator
#8
#8
Re: New IAF-MD9 Audit Man-Days Requirements for ISO 13485

I made a mistake in my previous post and referred to an incorrect document, go with Sidney, but NO you do not have that authority over the auditor so you need to go directly to your CB and ask "What's up, and why?"
 
M

MantleMickey

#9
#9
Re: New IAF-MD9 Audit Man-Days Requirements for ISO 13485

Thank you all for your insight.
It looks like we are all stuck with additional audit
days per this new requirement.
I go from 3 days to 5 1/2 days, with NO DESIGN
CONTROL, subcontractor only. What is the VALUE in this?:(
Good Luck All!
 
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