ISO 9001 & API Q1 Approved Supplier/Sole Agent

[Ampein]

Hi All,

I have a question in purchasing process but could not find any related posts in the forum, so like to post it for discussions and hopefully get some answers.

We have identified and qualified a critical material supplier. The supplier only distribute their products via an exclusively appointed local agent. As the agent is only a sales office, we cannot qualify them as manufacturer of the material.

One option is to qualify both entities (the supplier as manufacturer and the agent as distributor), then issue purchase orders to the agent and specify, in the PO, that the materials must be supplied by the qualified manufacturer.

Is this acceptable under ISO 9001 clause 8.4 Control of externally provided processes, products and services and API Q1 clause 5.6 Purchasing?

Appreciate discussions and suggestions for ISO 9001 and API Q1 expertise.

 

[jmech]

My response will focus mainly on the API Q1 5.6 requirements - if you meet these, then ISO 9001 8.4 shouldn't be a problem.

Yes, this can be done in a way that conforms to Q1. The option that you have described sounds like a good way to go.

I recommend taking extra care to ensure you meet the supplier evaluation requirements in 5.6.1. Because you are purchasing from the distributor, API would likely consider them the supplier for the purpose of this section, and the manufacturer part of their supply chain. Some distributors don't have a formal quality management system, which can make it challenging to conform to 5.6.1.2a, but usually there is a way to address this.

Do you have any concerns about specific requirements in either ISO 9001 8.4 or API Q1 5.6 that you think might be a problem?

 

[Ampein]

Hi Jmech,

Thank you very much for the valuable response.

The concern is normally POs are issued to qualified suppliers directly. And this this is the easy way to comply and for auditor to accept, without further explaining.

Yes, the distributor might not have any QMS implemented. However, there are appointment letters from qualified suppliers to the distributor stating that they are the sole distributor for the product.

(1) Will the appointment letters be sufficient to qualify the distributor as a supplier (AVL)?

(2) And the whole process of issuing POs to distributor, specifying products from qualified critical material suppliers, comply to ISO 9001 and API Q1 relevant clauses for purchases from qualified supplier?

Appreciate you views and thoughts.

 

[ros215011]

Hi Ampein,
as per API Spec Q1, company (YOU) can determine the QMS requirement for your distributor, as we know the QMS element for general is section 4 until 10 on ISO 9001:2015and I understand all elements would not applicable to your distributor but at least your distributor shall perform contract review before make order in place to you qualified supplier and if they have warehouse so they also must have final inspection before send the goods to you. the contract review and final inspection are example elements Quality system that you can verify.
therefore in my understanding, Auditor API would not accept the appointment letters to qualify your distributor to be at AVL.