Design - We use another firm to do parts of the design/development work

If a company registered to 9K2K uses another firm to do parts of its design/development work, does the design firm need to be registered to the same standard?

Rex

[Marc]

The design firm goes through the registration process like any other company.

However, there is no requirement for an ISO 9001 registered company to purchase design services from an ISO 9001 registered company.

[matthew evans]

I agree with you Marc but I would certainly want to make sure that the design company has gone through the supplier assessment process.

[Marc]

You treat the design firm as you would any supplier. You determine what is required, ensure (in what ever way you have determined is appropriate) they can supply it, check it when you get it (receiving inspection) according to your 'plan', etc., etc. None the less, they are simply suppliers.

Since you are a registered company and you are using another outside company to do design, would this not fall under section requirements for outside process 4.1. The standard states "Where an organization chooses to outsource any process that affects product conformity......control over such outsourced processes shall be identified with the QMS". Am I reading too much into this? I guess I don't fully understand this paragraph in the standard and what exactly they are referring to when they mention "processes". I see the note at the bottom which makes me assume the processes mentioned above are activities such as design, or the outsourcing of logistics. Can anyone shed some light? Thanks from GA...

[Marc]

Let's say you send out plating of a product part. You form something and send it out for plating. Then when you get it back you assemble the unit.

Now - what is the requirement?

The requirement is that you address the operation as you would any other for the most part. For example it will be on your process flow chart (or the flow chart will reference it in some way).

Basically you apply 4.1 c) "c) Determine criteria and methods needed to ensure that both the operation and control of these processes are effective."

This may include defined receiving inspection criteria - these are things you have to decide.

Now, in 4.1 it is stated: "Where a company chooses to outsource any process that affects product conformity with requirements, the company shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system." From your question I think you may be having trouble defining what a 'QMS' ( quality management system) is.

Your QMS can be illustrated in a number of ways. One way to think of it is as a standard fishbone. If you look at your business as a set of processes and inter-relate them this is not all that hard. The important part is ensuring you are clear about inputs and outputs and intra / inter-system communications.

Remember - if you are looking at a sub-contracted process, you are still responsible for determining critical characteristics and such. While you send the item out for sub-processing (for example plating), it is still a process step and is subject to QMS requirements.

Communications channels are represented in procedures. Management reviews, for example, are communication conduits. Staff meetings are conduits. Shift meetings are conduits. This should be only an issue of being ready to discuss the issue and to be ready with specific examples. Remember - communication with suppliers is as important as communication with customer and internal communication.