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We have done NOTHING toward the ISO 9001 transition
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We have done NOTHING toward the ISO 9001 transition
We have done NOTHING toward the ISO 9001 transition
We have done NOTHING toward the ISO 9001 transition
We have done NOTHING toward the ISO 9001 transition
We have done NOTHING toward the ISO 9001 transition
We have done NOTHING toward the ISO 9001 transition
We have done NOTHING toward the ISO 9001 transition
We have done NOTHING toward the ISO 9001 transition
We have done NOTHING toward the ISO 9001 transition
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  Post Number #9  
Old 13th February 2018, 08:35 PM
Golfman25

 
 
Total Posts: 1,376
Re: We have done NOTHING toward the ISO 9001 transition

Quote:
In Reply to Parent Post by pammesue View Post

We are ISO 9001 registered, about 60 employees. Manufacturing plant with some purchased products for resale. We have our own Design department. Mgt interest is sketchy. We have a quality manual and about 75 written processes...most are mfg work instructions that will not need to be changed.

Nashville TN area.
Like I said, how much you paying. I'm not a consultant but would love a trip to Nashville. .

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  Post Number #10  
Old 13th February 2018, 09:21 PM
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Randy

 
 
Total Posts: 8,688
Re: We have done NOTHING toward the ISO 9001 transition

Here's some questions, and please understand that I'm an auditor, I do nothing now but audit for a certification body, that's it, but I've done everything else in the past related to the management system process.

As an organization what is your reasoning for doing an ISO 9001 based quality system in the 1st place?

What is the value added benefit, to your company, of having a quality system with a 3rd party certification other than getting a warm fuzzy feeling and a nice sheet of paper with writing & a logo on the wall?

If it takes more than 60 seconds to come with an answer to each you'll be creating and embellishing.
Thanks to Randy for your informative Post and/or Attachment!
  Post Number #11  
Old 14th February 2018, 11:45 AM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,884
Caution Re: We have done NOTHING toward the ISO 9001 transition

Quote:
In Reply to Parent Post by Golfman25 View Post

Hire an outside consultant. I'm sure several will be happy to take your money. How much you paying?
As do many enterprises! Consultants are worth their weight in avoiding many pitfalls that we read about here daily...
  Post Number #12  
Old 14th February 2018, 11:51 AM
Brizilla's Avatar
Brizilla

 
 
Total Posts: 208
Re: We have done NOTHING toward the ISO 9001 transition

Quote:
In Reply to Parent Post by pammesue View Post

We are ISO 9001 registered, about 60 employees. Manufacturing plant with some purchased products for resale. We have our own Design department. Mgt interest is sketchy. We have a quality manual and about 75 written processes...most are mfg work instructions that will not need to be changed.

Nashville TN area.
I'm a QA Manager not a consultant but I just came into a company with the same problem. Light management involvement, a 2008 QMS that barely any document had been updated since 2011 and no work done. After the Lead auditor training in September it took me about 3 months to upgrade and update the whole system (which mostly had to be rewritten), retrain the internal auditors get in the quick audits needed for the whole system in order to get ready for a first week in February audit. Passed with 2 minors that were fixed before the auditor left. I hope this timeline is of use to you. It all depends how robust your current system is. Auditor training isn't tough if you already do process auditing. You don't need a quality manual in the new system, I have one it's only 4 pages.
  Post Number #13  
Old 14th February 2018, 11:54 AM
pammesue's Avatar
pammesue

 
 
Total Posts: 64
Re: We have done NOTHING toward the ISO 9001 transition

Quote:
In Reply to Parent Post by Brizilla View Post

I'm a QA Manager not a consultant but I just came into a company with the same problem. Light management involvement, a 2008 QMS that barely any document had been updated since 2011 and no work done. After the Lead auditor training in September it took me about 3 months to upgrade and update the whole system (which mostly had to be rewritten), retrain the internal auditors get in the quick audits needed for the whole system in order to get ready for a first week in February audit. Passed with 2 minors that were fixed before the auditor left. I hope this timeline is of use to you. It all depends how robust your current system is. Auditor training isn't tough if you already do process auditing. You don't need a quality manual in the new system, I have one it's only 4 pages.
well its good to know it can be done! The risk assessment is what I have an issue with. I want someone in here that can lead that and write the processes up accordingly.
  Post Number #14  
Old 14th February 2018, 12:13 PM
John Broomfield's Avatar
John Broomfield

 
 
Total Posts: 2,581
Lightbulb Re: We have done NOTHING toward the ISO 9001 transition

Quote:
In Reply to Parent Post by pammesue View Post

well its good to know it can be done! The risk assessment is what I have an issue with. I want someone in here that can lead that and write the processes up accordingly.
pammesue,

Developing your organizationís process based management system is itself a risk assessment as:

A. Top management determines the processes necessary to fulfill the mission

B. You work with process owners to determine what is done to fulfill process objectives.

C. The resulting flowcharted procedures are reviewed by each process team for accuracy (as-is) and feasibility (if the process is new).

Your existing management system may have been developed to focus on what is done to prevent nonconformity in realizing opportunities. When you update it the focus is the same except that you may tease out what the organization already does to assess and treat significant adverse risks.

Please also see my PM.

John
  Post Number #15  
Old 14th February 2018, 12:48 PM
Brizilla's Avatar
Brizilla

 
 
Total Posts: 208
Re: We have done NOTHING toward the ISO 9001 transition

Quote:
In Reply to Parent Post by pammesue View Post

well its good to know it can be done! The risk assessment is what I have an issue with. I want someone in here that can lead that and write the processes up accordingly.
My two NC's were Risk analysis & Interested Parties. We had discussed both at Management review but they weren't comprehensively documented. I did an Interested Parties list and Risk FEMA in a day. Both were accepted by the auditor. We'll be using SWOT in the future but didn't have time to get the information out and run it before the audit.
Thanks to Brizilla for your informative Post and/or Attachment!
  Post Number #16  
Old 14th February 2018, 02:14 PM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,884
Let Me Help You Re: We have done NOTHING toward the ISO 9001 transition

Quote:
In Reply to Parent Post by pammesue View Post

well its good to know it can be done! The risk assessment is what I have an issue with. I want someone in here that can lead that and write the processes up accordingly.
A risk assessment isn't necessary! All the ISO requirements ask you to do is identify internal and external issues - which can simply be accomplished through a SWOT analysis, documented in a Management Review. Simples!
Thanks to AndyN for your informative Post and/or Attachment!
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