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Purchasing requirements for Toll Manufacturers

QATN11

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#1
As a toll manufacturer, all raw materials and their external providers are specified by the customer which is their only customer of the toll manufacturer. The customer provides the bill of material and processing instructions. Initially, when preparing for my client's certification to ISO 9001:2015, purchasing was not included in their scope because they do not specify the raw materials, the suppliers of those raw materials nor is the toll manufacturer part of the supplier selection/qualification process. The toll manufacturer does place procurement orders to bring in those raw materials to meet the production schedule which is produced by their customer. If problems with a supplier or their raw materials are encountered, their only course of action is to address the issue with their customer.

During the initial registration audit, the CB Auditor says that they could not remove the purchasing process from the scope of their QMS and must have a process covering supplier qualification, supplier performance and all other requirements as if they had full control of supplier selection, qualification and raw material requirements.

8.4.1 states "The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations." The toll manufacture requires the suppliers to provide their materials CoA and all received lots are sampled, tested and approved before being used. The toll manufacture does maintain data on rejected lots and if a particular supplier is not performing, this is reported to the customer and it is the customer's responsibility to make any decision to address the situation. Their determination and application of criteria is they do not provide "evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements".

Question: How have other toll manufacturers addressed and applied Clause 8.4?
 
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#2
Technically you can't omit purchasing and 8.4.1. But they don't necessarily have to be applicable. In your case, all the criteria are flowed down from the customer. So you'll want to reference the customer requirements in your process documentation. So for example, selection is done by customer. You monitor and provide data. Customer and you might team up to do evaluation to certain criteria. Etc.
 
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