Subcontracted Services - Permissible Exclusions



If a company subcontracts an activity such as Design Control, is this a permissible exclusion?

My opinion is that it is not an exclusion, as it would be if the company were not responsible for design (if we build-to-print, for example -- customer provides the design). The standard clearly states that it cannot be excluded if it affects the organization's ability or responsibility to provide conforming product.

In my opinion, even if you don't have the capability to do design but the customer holds you responsible for it, it cannot be excluded. Furthermore, if the activity is subcontracted, the subbed processes must be identified and controlled (per clause 4.1).

This seems fairly obvious to me, but an instructor in an RAB-approved Transition Course I took stated that this subcontracted design activity would be a permissible exclusion. I wholeheartedly disagree, in this case, but am curious how others would address this in their quality manual? Would you include section 7.3, but state that the activity is subcontracted (and therefore controlled)?

It's very interesting to observe these initial (and varied) interpretations of the new standard.

Any feedback would be appreciated. Thanks. This site is very useful...

ps) Anyone else have the new standard on their Palm Pilot? It's cool.

Julie Drysdale

Dan Larsen

I tend to agree with you, Julie. I think the key is the fact that your company is taking the responsibility for the design.

Now, with respect to the manual, I think I would write it in that (and this assumes that all design work is subcontracted) the company subcontracts but takes responsibility for design, and that the subcontract designers are subject to purchasing requirements that reflect and incorporate the requirements of the design clause. Then I would prepare a purchasing document that would become part of the PO package that goes out to the supplier. I'd also audit my supplier to make sure he is conforming to the requirements.

Can't say I've ever run across this (I tend to work with non-design companies), but it would seem the logical approach.

Playing the devils advocate, I guess it might be possible to argue that the design clause doesn't apply to me if I subcontract all the design work. But if I were the auditor in that situation, I think I would take a hard look at how the company is controlling the subcontracted work. I'd also carefully consider the scope of the registration. If the word "design" is in the scope of the registration, I think it would have to be a finding if there were no design controls.

Doug Stimson

Check out titled "subcontracted or outsourced processes.
".......outsourced or subcontracted to an external organization is NOT adequate justification................


To me, subcontracting the full design work can create other problems, since there is always a need to align the customer requirements not only to engineering specs but also to the manufacturing or service processes. When you subcontract part of the design work (do testing, make drawings, etc.) it can ve valid for optimal resource utilization, but IMHO the design process is one that you should own and manage so direct interaction with customer and interal areas are assured. Summarizing, I think that some specific design activities could be sub-contracted and managed as a purchase but if you want to do that with the full design process it can be difficult to handle from the point of view of a certificaton audit.
Only if your company does not carry out design at all may be justifiable to exclude this requirement for iso 9001.

Gus Gutierrez

Al Dyer


To which standard are you referring?




I tend to agree with your instructor. I suggest you speak with the registrar you will be using. Find out if, according to the circumstances with your company, the registrar will allow the design function to be listed in your company scope.

I have implemented ISO in a number of companies where the design function was out-sourced. It was not included in the scope of registration for the reason that the companies had only limited control over the out-sourcing, not to the extent as when the design is a part of your own facility.

Other considerations, is the design an element outlined on your organization chart; this would be difficult to audit internally and would need to be a supplier audit.



First of all, thanks to everyone for the replies. To clarify, this is not an actual case at my company; I am a consultant (uh oh). This was a question posed as an example in a 9000:2000 Transition training course.

The guideline found at is very clear about this: "Where the overall responsibility for product realization belongs to an organization, the fact
that a specific product realization process (such as product design and development or
manufacturing) is outsourced or subcontracted to an external organization is not an adequate justification for the exclusion of this process from the QMS."

However, I also agree that it would not be very common to outsource all of your design work and still take responsibility for it.
This was simply an excercise in the class; in a real-life circumstance, I suppose other factors could apply.

I much more commonly see manufacturing being outsourced, however, and this is why I asked.
In this case, the company cannot say that the manufacturing requirements do not apply; in fact, they are responsible (through their supplier management system) for managing their suppliers to ensure sufficient control.
In this case, the scope of the registration reads "...for the design and management of manufacturing of..." It's a bit awkward, but this is what the registrar recommended.

Julie Drysdale

David Mullins

Covered under purchasing, I believe. External auditors should assess your ability to ensure that the purchased designs meet your requirements.

I recall a question that was very similar to this one, about a year ago, and there was a fair bit of debate in the thread.

At the end of the day, it depends on the degree of control your company wishes to economically and efficiently apply to this process.

My standard caveat of making sure you're adding value by your interpretation applies.



Fully vaccinated are you?
->Furthermore, if the activity is subcontracted, the subbed
->processes must be identified and controlled (per clause

When you outsource design, you look at your outputs to the design company and their feedback (their output) to you. You have to define the requirements for them to do the design (purchasing of a service). If I build a building and I subcontract the design part (maybe I'm just a turn-key who coordinates getting everything together and getting the building built), my procedures and such have to describe what outputs I have to each service I sub-contract as well as purchasing related aspects). In so far as design goes, if I do anything 'listed' in section 7, it is applicable to my registration. If I don't, it's not. I would state my output to the design firm but it may be I'm responsible for part or all of of 7.3.1. I have to ask myself what I do and do not do as I go thru the standard line by line.

->In my opinion, even if you don't have the capability to do
->design but the customer holds you responsible for it, it
->cannot be excluded.

You're outsourcing it and the customer simply holds you responsible for it. This doesn't change anything at all - you're outsourcing it whether the customer requires it or not because it is not a 'core function' to your business.

Look at your part in the whole thing. Say I farm out the design but I do validation testing in-house. I'm 'responsible' for addressing the requirements of 7.3.6. I cannot say I am not responsible for addressing 7.3.6 just because it is a sub-clause of 7.3.


hello every body
am rewriting a QM for my company for the BSI...i get stucked in the Quality Assurence for the Control of Sub Contract companies. To be honest the company was ignoring to put standard criterion process for accepting or rejecting a subcontractor. so if any one can give me ideas about wht should be the rules and regulations for accepting a subcontract company for {water tank builders}..:notme:

Thank you for your time
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