Integrating a Multi-Management System - What documents & records must we have?

S

ssz102

#1
Hi, All:

Our group are planning combining multi-management system including ISO9001, AS9001, TS16949 and ISO13485

meanwhile, they also want to implement listing certification, that's mean one cert contain many its sub-company;

and out headquarters are location on American, and others are in China and Mexico;

And my question is:

As sub-company, what documents or record do we need to prepared to ensure this certification passed satisfactory?

Or what documents or records must be existed to our company for above four system standard

If anyone can sharing some idea i will be appreciate, TKS!
 
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M

mortby

#2
The best place to start with thinking about this is to clearly state what each site does.

What are the processes you use at each site, how do the processes interact with each other and how do the sites interact with each other?

Start by knowing who is responsible for what and the procedures / records will fall out of that.
 
E

ErikS

#3
I would consider what the customer demands are at each site (I'm agreeing with mortby). If you have a Medical Device (13485) plant seperate from Aerospace then they both wouldn't necessarily need to have both certificates.
 

Helmut Jilling

Auditor / Consultant
#4
The purpose for a combined system is to reduce redundancies and duplications. For example, a document control procedure for ISO 14001 should contain the same requirements as a document control procedure for ISO 9001. If it says the same thing, you can combine it into a single document for both standards. If multiple locations and sites agree to follow the same rules, then the same procedure can be applied to multiple locations.

So you can build a system that addresses common requirements for multiple standards, and multiple locations, but reduce redundant documents. We call that integrating your systems.

It is a little complicated to get started, but once you have a good outline and everyone agrees, then it rolls pretty well.

If you need more specific guidance, you may send me a private message.
 
S

ssz102

#6
thanks for your ideas!

the way of combining i know a little, but the biggest problem is that i don't know what data or records for the three standard are need to established by us

especially is ISO13485 and AS9001
 

Helmut Jilling

Auditor / Consultant
#7
thanks for your ideas!

the way of combining i know a little, but the biggest problem is that i don't know what data or records for the three standard are need to established by us

especially is ISO13485 and AS9001

That is why I say you need to read the standards more, and maybe take some training. Then you will know them better, and have the answer to your question. You are trying to make lists. First, I think you must know the standards better, so you can build the system better. Don't try to take shortcuts.
 
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