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Registrar Nightmare... Document Review and Other Auditor Issues

Q

qualeety

#41
#41
MsHeeler said:
BTW have you ever heard of a 5 day audit for a facility with 80 employees?:nope:

MsHeeler
Click to expand...
Yep...one facility, one department (not a company), 5 sections within the department, about 40 employees...1 day for document review, 1 day for familiarization to explain/show what we do..which i still have difficulties comprehending (at my request) and 5 days of audit (at my request)...since we failed (see my other post), we have scheduled addtional 2 days of re-audit...and am i hopeful? :notme:

well, am sure we will get our certification but......what can you do, huh? :bonk:

All I can say is...it was a learning experience...
 
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J

jem63

#42
#42
newbie poster here-

5 days for an audit. heck no!

I am in a medical device mfg company of 300+ and we are audited to a number of regs. easly complete in 3-3.5 days
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#43
#43
jem63 said:
newbie poster here-

5 days for an audit. heck no!

I am in a medical device mfg company of 300+ and we are audited to a number of regs. easly complete in 3-3.5 days
Click to expand...
Well it depends. What "regs" do you get audited to? How many auditors are involved in these 3-3/5 days? Obviously if you have 2 auditors for 3 days, that adds up to 6 auditor-days.:tg:

I checked your ISO 9001 and 13485 certificates online. I find interesting that your ISO 9001 certificates were issued under EAC Codes different than the one that ANAB uses to describe Medical Devices: #40. It could be a coincidence but your CB for ISO 9001 is not accredited for Code 40 with ANAB, according to their Directory, http://www.anab.org/Directory/Directory_Search.asp
Maybe you want to ask them about this.
 
J

jem63

#44
#44
Our previous registrar had their MD 9001/13485 abilities revoked. :mad: :bonk:

The certs you viewed are in the process of being updated and replaced with our new certificates. :cool:
 
M

MsHeeler

#45
#45
qualeety said:
Yep...one facility, one department (not a company), 5 sections within the department, about 40 employees...1 day for document review, 1 day for familiarization to explain/show what we do..which i still have difficulties comprehending (at my request) and 5 days of audit (at my request)...since we failed (see my other post), we have scheduled addtional 2 days of re-audit...and am i hopeful? :notme:

well, am sure we will get our certification but......what can you do, huh? :bonk:

All I can say is...it was a learning experience...
Click to expand...
Where was the failure? :bigwave:

Just Curious
MsHeeler
 
M

MsHeeler

#46
#46
Ok, new question...

Our registrar wants to audit our corporate office for sales and marketing. Where is the shall? Did I miss that?

He also wants to audit them for Materials Management and Purchasing. We only state that they are responsable for the Approved Suppliers list. I can see that part but...

He wants to audit the warehouse for "purchasing process and purchasing information, order entry for "product service and provision", document control for "verification of purchased product". But he is not wanting to audit process engineering for "determination of requirements related to the product"

I think he has been drinking. :bonk:

Anyway any opinions on the Sales and Marketing?

MsHeeler
 
H

Helmut Jilling

Auditor / Consultant
#47
#47
jem63 said:
newbie poster here-

5 days for an audit. heck no!

I am in a medical device mfg company of 300+ and we are audited to a number of regs. easly complete in 3-3.5 days
Click to expand...

You may be missing the point. In ISO certification land, the auditors don't get to pick how many days the audit will be. It is mandated by official lists and we have to work to those to maintain certification. Other regs (like GMP) may not have that requirement.
 
H

Helmut Jilling

Auditor / Consultant
#48
#48
MsHeeler said:
Ok, new question...

Our registrar wants to audit our corporate office for sales and marketing. Where is the shall? Did I miss that?

He also wants to audit them for Materials Management and Purchasing. We only state that they are responsable for the Approved Suppliers list. I can see that part but...

He wants to audit the warehouse for "purchasing process and purchasing information, order entry for "product service and provision", document control for "verification of purchased product". But he is not wanting to audit process engineering for "determination of requirements related to the product"

I think he has been drinking. :bonk:

Anyway any opinions on the Sales and Marketing?

MsHeeler
Click to expand...
The processes and activities defined by your Quality Manual must be audited, wherever they are performed. If Corporate or the Warehouse perform functions defined by your QMS, they would need to be audited from time to time. If not, they typically would nt be.

Unlike the old ISO, we are auditing a whole system here, not just your facility. How this applies to your particular situation would need to be reviewed. We don't have enough info here to make a firm decision.
 
J

jem63

#49
#49
hjilling said:
You may be missing the point. In ISO certification land, the auditors don't get to pick how many days the audit will be. It is mandated by official lists and we have to work to those to maintain certification. Other regs (like GMP) may not have that requirement.
Click to expand...
Yes! I am aware of this, 5 days seemed a bit lengthy. I was only responding as being suprised :)
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#50
#50
MsHeeler said:
Anyway any opinions on the Sales and Marketing?
Click to expand...
Sales, more than marketing, has a clear impact on the QMS. If the processes are "outsourced" to a corporate office, how do you ensure that what they do comply with the applicable requirements of ISO 9001?
ISO 9001 said:
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.
Click to expand...
Even though you might have not "chosen" to outsource them, the premise applies. ​

hjilling said:
You may be missing the point. In ISO certification land, the auditors don't get to pick how many days the audit will be. It is mandated by official lists and we have to work to those to maintain certification.
Click to expand...
There are no mandates. There is a "method" for estimation of auditor-days, based on Annex 2 of the IAF Guidance to ISO/IEC Guide 62 document. It is a well known fact that some CB's lo-ball the auditor-days in order to offer a lower quote to their prospects. There is WIDE variance of estimation of auditor days in this business.
 
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