Quality System for Multiple Facilities

R

Randy-BCEC

#1
We are a small manufacturer of Home Therapy Products (class II exempt.) As I am working feverishly to put together a real quality system, I keep running into a big unknown question. Since Engineering and Administration is in one facility and Manufacturing is in another facility 55 miles away, will I need to create two separate quality systems? If so, can I just copy one and change the company info?
 
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#2
We are a small manufacturer of Home Therapy Products (class II exempt.) As I am working feverishly to put together a real quality system, I keep running into a big unknown question. Since Engineering and Administration is in one facility and Manufacturing is in another facility 55 miles away, will I need to create two separate quality systems? If so, can I just copy one and change the company info?
Hello and welcome to the Cove. I'm sure you'll get a lot of answers here!

You quality system should cover the 'company' not the different locations. The fact that there's 55 miles between the two should not be a factor. Indeed it is possible - and for some businesses - to have a common quality system across continents! Since your system describes your qms processes and their controls - for the most part - it is somewhat independent of the locations of those processes.
 
R

Randy-BCEC

#3
I appreciate the help, AndyN. I guess I remember back to a seminar on ISO13485 that talked about each location needing to be registered independently. I took that to mean each facility needed its own quality system. It makes sense that one quality system will work for the entire company.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
You're on the right track now, Randy-BCEC. Although sites usually do register separately, if they are the same company, the same QMS can help provide the continuity needed to help show that one site's output is providing adequate input for the other site; how that is planned and executed, and how it is corrected/improved. The "mother ship" should oversee these major functions, leaving their management details to local leadership.

As such, each site may have exclusions, but take care to recognize how much each would, or should do within the QMS - though perhaps differently than the other site. For example, the engineering site might plan the monitoring and measurement process while the manufacturing site carries it out. They should have open communications and work together to understand how well both activities are helping the eventual goal of getting good product/service to the customer, take actions, and assess success.

I hope this helps!
 

Phil Huber

Inactive Registered Visitor
#5
Randy,
Jennifer is right on track. Your level 1 and 2 documents will be the "mother ship" as it were with level 3 documents providing the specific work instructions that address the activities at that location. Level 4 documents, quality records (checksheets, control plans, etc.) can be managed by the "monther ship" and, once again, the format of these documents dictated by each site specific activities.

I am implementing a system much like you are with a "headquaters" in Michigan and 4 specific locations performing similar activities in three different states. Our level 1 Quality Manual addresses the requirements of the ISO 9001 international standard and references supporting level 2 Quality Procedures required by "headquarters". Specific instructions on how to comply with these Procedures are controlled by the Manufacturing Plants and are written to address those specific activities at each location.

"Headquarters" has sales, design, quality systems, purchasing, human resources, forecasting and information technology. Each location has engineering (manufacturing process), operations, quality control and general facilities support.

To further complicate our issue, "headquarters" reports to the "corporation". This results in layered audits: "corporate/headquarters", "headquarters/location" and "location/internal". If you are new to the Cove, you will find a number of Threads that discuss QMS and the various supporting activities. Go to the "Search" menu in the upper right hand tool bar and key in your question. You will be pleasantly surprised!

Let me know if I can be of further help,
Phil Huber:agree1:
 
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