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texkb
The company I work for is getting ready to sell our product internationally. For the first month or two we will be shipping product directly from our warehouse to the end customer. Our ultimate goal though will to be ship larger boxes or pallets to a company oversees that we have evaluated to ship the products to the end customer, doing the shipping this way will provide cost savings to both the customer and us. We understand that this will now be an outsourced process in our quality manual and have a couple questions in terms of controlling this process.
1) The company we are using has two storage areas, one that is 9001 compliant and one that is medical device, 13485 compliant, there is a cost difference between the two storage areas. Our product is not sterile device and will be clearly marked on the exterior box and interior box for storage. Our question is do we need to store our device in the 13485 section of the warehouse or can we store it in the 9001 section of the warehouse? I suppose as long as the documentation for storing items in the 9001 section of the warehouse met our requirements it would be fine to store our product in that section?
2) In terms of order fulfillment would we supply similar controls? Review each the order fulfillment requirements for each section and determine which one meets our standards?
It should be noted the the actual fulfillment process will be performed by us sending them a file of orders that need to be shipped including customer name, shipping address, product id, and shipping method. After shipping the company will send us a return file indicated product shipped, product serial number, carrier used, and shipping address. We will then take that file and update our system so we have a record of the shipment.
Hopefully the above information make since and any comments or advice would be greatly appreacited.
1) The company we are using has two storage areas, one that is 9001 compliant and one that is medical device, 13485 compliant, there is a cost difference between the two storage areas. Our product is not sterile device and will be clearly marked on the exterior box and interior box for storage. Our question is do we need to store our device in the 13485 section of the warehouse or can we store it in the 9001 section of the warehouse? I suppose as long as the documentation for storing items in the 9001 section of the warehouse met our requirements it would be fine to store our product in that section?
2) In terms of order fulfillment would we supply similar controls? Review each the order fulfillment requirements for each section and determine which one meets our standards?
It should be noted the the actual fulfillment process will be performed by us sending them a file of orders that need to be shipped including customer name, shipping address, product id, and shipping method. After shipping the company will send us a return file indicated product shipped, product serial number, carrier used, and shipping address. We will then take that file and update our system so we have a record of the shipment.
Hopefully the above information make since and any comments or advice would be greatly appreacited.
