Subcontracting Finished Product



I have been asked to look into issues with ISO covering some jobs that we are going to subcontract out as finished when we receive them, then we just box them up and send them to our customer. I need help clarifying just what I may need to change to make sure we still comply to ISO 9002:1994. I have visited some older threads on this and I am still confused about the whole thing. We have a lot of stuff partly made outside but this is a different animal to me. Do I just need documentation to support our QMS (traceability,inspections etc) from the subcontractor?:confused:



Although you are needing to comply with ISO 9002:1994 at this time, it might be worth looking ahead at the requirements from ISO 9001:2000. Regarding outsourced processes, clause 4.1 says:
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.

Regarding ISO 9002:1994 I would start with looking at 4.2.3 Quality Planning. The first sentence states:

The supplier shall define and document how the requirements for quality will be met.

I think this is the place to describe the controls your organization has over outsourced processes to ensure that requirements for quality are met. Then I would look at 4.6.1 & 4.6.2. They really mirror in more detail what ISO 9001:2000 says in clause 4.1.

I'll leave the part about traceability to someone else to address. In my past experience, traceability was not a requirement for our product, but I did require traceability by lot to inspection records. I did this mainly to comply with the requirements for Inspection and Testing in section 4.10.

I would encourage you to look at certifying your subcontractor to provide documented evidence of inspection and conformity so that you don't have the burden of re-inspecting unnecessarily. Once you're confident that you have a certified supplier, your job of ensuring that the requirements for quality are met can be reduced to supplier audits, and if necessary inspection of random samples.

I hope this helps.

Best Regards,


Spaceman Spiff

My company purchases private label products from the Far East and markets them in our catalog along with ones manufactured in the USA. How we address this issue is by performing incoming inspection on products as if they are components. This way as Hank suggested, it is covered by 4.6 (ISO 9001: 1994). We also require these suppliers to be ISO certified or working towards certification.


7.5.1 and 7.5.2?

Does subcontracting in a way have anything to do with 7.5.1 and 7.5.2? Validation of special processes.....The company I'm working for doesnot provide any service provision but production provision....I've always found this section difficult to expand and write....can I exclude part of these two sections?....Or does this have more to do with qualifying suppliers and their processes?...Hope this is in the right always I appreciate any help...this site has all sorts of good info!!!:)




I don't read 7.5.1 or 7.5.2 as applying to subcontracted product or to the qualification of suppliers and their processes. I believe that 7.5.1 refers to the controls that a company has over its production or service processes. It involves making sure that the appropriate information and equipment are available and implemented. In a manufacturing environment, this would mean having the current revision of drawings, proper work instructions, and the necessary inspection equipment being used correctly,

I believe that 7.5.2 refers to a product or service that can't be deemed acceptable until it is in its application. In other words, you have to wait until a service is performed or a product is installed before you can evaluate whether it meets the intended requirements.

This is just my opinion. Read on for the viewpoint of others.

Top Bottom