Outside Manufacturer = non-ISO (Outsourced Processing and Shipping)

[MBraun76]

Hello Everyone,

So here is my question. Let us say that my company has an agreement with another plant to perform work on our products and then ship them straight to the customer without us having seen the product. Now let us add in that the other company is not ISO certified. What do we need to do in order to cover ourselves?

I am imagining that we would need to have certain clauses in our quality manual as well as instructions for the other plant in our contract with them. I am not sure however as to what exactly we need to be in accordance with ISO.

Thank you for your help!

 

[Randy]

Re: Outside manufacturer = non-ISO

This to start with maybe this....

7.4.3 Verification of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

8.2.4 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product
requirements have been met. This shall be carried out at appropriate stages of the product realization process
in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria
shall be maintained.

Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4).

The release of product and delivery of service to the customer shall not proceed until the planned arrangements
(see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where
applicable, by the customer.

 

[Sidney Vianna]

Re: Outside manufacturer = non-ISO

What you described is an "outsourced process" in the context of ISO 9001. We've had numerous discussions on what is necessary for an outsourced process to be "controlled". Suggest you search those threads and also look at the ISO Guidance on control of outsourced process, with a special attention to the

The outsourced organization does not necessarily have to have a certified Quality Management System, but it has to demonstrate the capability of the previously mentioned processes.

paragraph.

 

[Randy]

Re: Outside manufacturer = non-ISO

...And as Sidney said as well.

 

[MBraun76]

Re: Outside manufacturer = non-ISO

Thanks everyone. This is definitely going to require some careful planning but I appreciate the push in the right direction.

 

[Randy]

Just show effective control and make sure you have some kind of records ( 45's, 78's and 33-1/3rds don't count)

 

[AndyN]

Re: Outside manufacturer = non-ISO

Thanks everyone. This is definitely going to require some careful planning but I appreciate the push in the right direction.

And that's a clue, right there! Why not ask (contractually) your supplier for their (Quality) plan to control what they do for you, all the way through, from receipt of what you send (would they know what to do and how to react if it was wrong?) right through to the point of delivery...

 

[somashekar]

Hello Everyone,

So here is my question. Let us say that my company has an agreement with another plant to perform work on our products and then ship them straight to the customer without us having seen the product. Now let us add in that the other company is not ISO certified. What do we need to do in order to cover ourselves?

I am imagining that we would need to have certain clauses in our quality manual as well as instructions for the other plant in our contract with them. I am not sure however as to what exactly we need to be in accordance with ISO.

Thank you for your help!

With all the good ways of outside manufacturer controls said till now, I still have a simple question...

Is your company certified to ISO 9001 or have established a management system per ISO 9001 ?

 

[MBraun76]

Yes Sir, We are ISO 9001:2008 certified. However this is something that has always kind of slipped through the cracks apparently during past audits. My boss and I (the only two in QA) came in at the same time and we inherited a rather antiquated system. I am new to ISO so my question was innocent when asking if our manufacturer was ISO certified which led down this path to where I am now. So while my company has always had a quality agreement with the manufacturer it was not ISO based or compliant. I am now trying to put together a rough draft with bulleted points that our legal can turn into an amendment of our contract.

Thanks again to everyone for the input, please keep any ideas you have coming. It is great to have this forum, its answered so many questions for me!

 

[JaneB]

this is something that has always kind of slipped through the cracks <snip> So while my company has always had a quality agreement with the manufacturer it was not ISO based or compliant. I am now trying to put together a rough draft with bulleted points that our legal can turn into an amendment of our contract.

I'm not quite sure what you mean by 'not ISO based or compliant'. Your agreement with your supplier does not need to be 'ISO based'. The fundamental question is: what steps/processes/methods do you use in order for you to ensure the quality of whatever it is that they provide on your behalf to your customers? And do you have some kind of evidence (records) that show this?

For example, how were they chosen? Did you have some specified criteria other than 'close and cheap'?
Did someone go and look at their factory/processes/methods/tools/personnel etc in the first place to feel comfortable about using them? Does someone go back there periodically to inspect 'em again?
Does someone check the results of what they're producing for you, including close tabs on any negative customer feedback/complaints? etc.

A legal contract is quite possibly a good thing to have in place, but it isn't the only thing. Do not forget to also look at your internal processes: how you communicate requirements to them (including changes) and how you monitor their performance.