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We have done NOTHING toward the ISO 9001 transition

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Brizilla

Brizilla

Quite Involved in Discussions
#12
#12
pammesue said:
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.
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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.
 
P

pammesue

#13
#13
Brizilla said:
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.
Click to expand...
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.
 
John Broomfield

John Broomfield

Staff member
Super Moderator
#14
#14
pammesue said:
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.
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pammesue,

Developing your organization’s 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
 
Brizilla

Brizilla

Quite Involved in Discussions
#15
#15
pammesue said:
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.
Click to expand...
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.
 
A

AndyN

Moved On
#16
#16
pammesue said:
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.
Click to expand...
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!
 
somashekar

somashekar

Staff member
Super Moderator
#18
#18
pammesue said:
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.
Click to expand...
Its a risk based thinking that is asked for in the risk based approach.
That you are in a good and profitable business, and an ISO 9001 organization, is in itself a great standing.
Now where are some of your vulnerable processes. Do the procedures, controls and training at such places needs attention. By doing this consciously and by keeping a record (Management review) you are good.You need no scoring and tabulation aka Risk management. What else is the specific that you are caught with ?
You need no consultant. Just need understanding and confidence..... Good Luck
 
John C. Abnet

John C. Abnet

Teacher, sensei, kennari
Staff member
#19
#19
Good day @pammesue;
I am certain there are numerous participants on this site who are very capable of assisting you. I hesitate to "promote" via this site in order to keep Elsmar.com from becoming a commercial rather than an informative source of free information. However, since you have specifically asked for potential consulting/contracting options, I encourage you to reach out to me via my LinkedIn page/credentials. What you described is within the scope of what I do, and have been specifically doing for numerous companies. Feel free to contact me via LinkedIn and we can begin a dialogue regarding options to help your organization with what you are needing including references.
Be well.
John C. Abnet
 
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