Experience / advice for integrating API Q1 9th with a WCM program

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Puck81

Starting to get Involved
#1
#1
Does anyone have experience / advice for integrating API with a WCM program? We are a company that is currently ISO 9001 but switching to an API certification in 2015. Now we've decided to also implement WCM methods also. Any help would be appreciated.
 
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bluepagen

#4
#4
If it was me, I would do a gap analysis between the Annex in Q1 9th edition to the requirements you are currently practicing. Include the procedures, manual, records, forms, training in your current system. That will help you to see what you may have already covered along with the requirements that would be lacking.
 
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Puck81

Starting to get Involved
#5
#5
Thanks for the advice, I appreciate it. One of the things I'm concerned about is if I would be able to replace corrective action with kaizens. I would like to avoid that if possible.
 
B

bluepagen

#6
#6
In Q1, in your required procedure, you should relate the 2 to each other, but am unsure it would fly if you used it in place of. Perhaps an auditor will weigh in on this, but they are pretty clear in what is required. Good Luck!
 
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