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Babak Baghaei
Hello dear fellow members, I wanted to ask if anyone could help me understand if using 8D methodology is a ...
Hi  Babak Baghaei ‍  - I'm tagging a couple of people from the Automotive Division that might be able to Lou Ann ...
I would have to double check the standard to find the clause, I know most OEMS require it to be used or they will have ...
Thanks Robert!
Anthony Meier
Hello all,  I am looking for guidance on best practice for addressing missing training records for existing ...
As an auditor, I would accept a document signed and dated byeach employee per job description of their ...
I second Shelley's comments.  Generally speaking, every quality gap that is identified needs to be addressed ...
I agree with all said and have been in similar situations. The important issue is that you identified an issue and ...
One possible solution would be to do a general review training where you hand them some paperwork and ask a few ...
Thanks to all of you for your comments and input.  It is much appreciated and I feel I have a solid path forward ...
Charles Nigro
A question from a senior member of my company was can you become ISO certified when you’re not a profitable company. ...
Are you talking about ISO 9001? 
Diana Baldi
Hello fellow auditors, audit program managers, and anyone who needs to understand auditing,  I put together a 48 ...
Anthony Meier
If after a certification audit, and organization broadens its scope by the addition of a new division, does the ...
Anthony Meier Nov '20
Duke Okes Duke Okes Nov '20
That question can best be answered by your registrar.

However, it would likely depend on how interdependent the ...
Your registrar has to assess this after an application of scope change is made. 
I just went through a second expansion of scope.  Generally the process requires a definition of scope expansion ...
Thanks all for your feedback. It is appreciated.  I apologize for my delayed response.
Maida Sussman
Hi All, I'm new here so forgive me if I should know better... I'm trying to help my small mfg customer establish a ...
Maida Sussman Dec '20
Hi Maida Sussman ‍ - Welcome to myASQ & thanks for joining!  No need to apologize - you came to the right place to ask ...
Thanks in advance!
HI Trish, I appreciate the acknowledgement but I do not have anything like that anymore.    Maida, the key is to ...
Maida, No one should ever need to worry about being to new to ask questions at anything in life. I am the ISO ...
Jerry Rice Jerry Rice Dec '20
Maida,

Can you clarify what you are looking for? A tool for developing Quality Policy statement? Are you looking ...
Laurence George
2013 ANSI/AAMI ES60601-1:2005 & A1:2012 “Medical Electrical Equipment, Oxygen-Rich Environment,” ...
Laurence George Sep '20
I find your question very interesting and this is related to something that I have been developing for 20 years ...
GERARDO MORENO YEPEZ
Good morning all. My name is Gerardo Andres Moreno Yepez, and I have been an ISO auditor in quality, occupational ...
Zubin Khalfay
Any advice on designing a QMS for a small organization? where there is not a lot of hierarchy, can any one share their ...
Zubin Khalfay Aug '20
I'd say keep it simple.  This new standard allows for less documentation than the 2008 version did, but you should ...
Hi Zubin Khalfay ‍, 

Perhaps this Quality Press title could help you?

ISO 9001: 2015 Handbook for Small and ...
I'm tagging  Amanda Foster ‍ - I know she took her former company through ISO.  Any suggestions Amanda Foster ‍ ?
Hi Zubin Khalfay ‍!

The most important thing is you get leadership commitment and buy-in. Since there is little ...
Hello, What about a small company with very little in the way of process documentation?  I fear this will present ...
Brittany Crocco
I am looking into the feasibility of outsourcing supplier qualification audits for some of my company's ...
Brittany Crocco Oct '20
Hi Brittany Crocco ‍  - I pinned this to the top, hoping someone might know someone....doesn't seem to be helping.  ...
Duke Okes Duke Okes Oct '20
No recommendations here but I would personally start by searching the web for auditing firms located in the ...
Brittany - try this - I have seen many of our customers have used their services to audit their suppliers.  ...
Thank you all for your input! I am on my way with getting an audit scheduled now and appreciate your responses.

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