Applicability of 4.9 When Design is Product


j r moses

i am involved in the development of the Quality Management System for a small company (20 employees) which is designing Plants for waste water treatment based on the specific requirements of the customers.
my client has the option of offering design alone or also supply equipment based on its own design and also take up installation / commissioning of the plant.

recenrtly we had the system audited by an external auditor who raised comments that the system did not adequately address requirements of section 4.9.

our argument is : there is no manufacturing involved. the section on 4.9 in our procedure adequately covers activities involving project planning and execution, operational requirements for maintaining the plant supplied and periodical inspection / analysisof the samples from the effluent after treatment.

is our argument valid ?
are we missing something important?


dr p r madhavan

Christian Lupo

I guess it would depend on the specific issues raised by the auditor. 4.9 does apply even though you are not a manufacturer, it is harder to address and it's possible that the auditor does not have adequate experience in your SIC code. But w/o specifics its difficult to tell if the auditor made the wrong decision.


Fully vaccinated are you?
I want to ask a few people about this. I'll respond in a day or two.

How about you other folks reading this thread? Ideas? Experiences with a company whose product is a design?

barb butrym

Quite Involved in Discussions
Design is the process so 4.4 is extended to include the requirements of 4.9 as would any service organization's be in your extended scope......your sales and installation for instance need to met the requirements of 4.9.

There is no way, short of an audit, to tell if you were compliant or not.....words out of context are difficult at best to interpret.

This is one of the more difficult scenarios for an auditor....without experience in that field, they could do more damage than good. You need to understand where they are coming from and why they feel it was inadequately covered in order to make a decision.

Jase Eyre

I agree with Barb on this one. I have worked with a company whose 'products' are designs. Section 4.4 (~7.3 in the 2000 revision)applies without question, but 4.9 (~7.5) presents problems insofar as the requirements in this clause appear to be duplications of 4.4 (because design IS production in this case and have already been addressed). Surely the Standard doesn't want to do all this again?

Well, no. The Standard is merely being comprehensive. The problem of compliance can be overcome by bundling together 4.4 and 4.9 (or 7.3 and 7.5) in a single set of procedures or practices. Often, measures applied to comply with 4.4 also address the requirements of 4.9. This simply has to be made explicit to your registrar and demonstrated in your documentation.



dr madhavan

In his book titled " ISO 9001 for Engineers and Designers (published by McGraw-Hill)", the Author - Stephen J Schoonmaker, lists the requirements for designers/engineers as Clauses: 4.2.1,4.2.3
4.10 and 4.11.

does it mean that we do not consider 4.9 at all? there is no reference to this clause in his entire book for designers!


Fully vaccinated are you?
I would map the 4.9 requirements (as applicable) to your 4.4 procedures. You could do this on your quality manual. Where it is obvious that a 4.9 element doesn't apply, say so in your map or quality manual.


I would suggest a process-approach to documenting your management system, in which you follow your practices rather than clauses of the standard. Ensure that all requirements in ISO9001 are considered when documenting your processes, but in a way that remains relevant to the business. If your auditor is asking where the requirements of 4.9 are addressed, he/she needs a kick in the pants or else does not have appropriate experience to audit within your industry (as someone has already suggested).
The 2000 revision is a good attempt to making ISO9001 a process-based structure, and has less emphasis on "documented procedures", allowing you more flexibility to rely on qualifications, training records and customer feedback to prove (objective evidence) you have your processes under control. This will force auditors to be more aware of the industry practices without relying on your procedures and then robotically quoting from ISO9001 where he/she cannot find those words in your procedure. It will be both interesting and a challenge as we move towards 9k2k.


IMHO the design company is ISO9002 because his product is what he designs. The process is how he does design.
In case that he wanna be ISO9001, his product is the drawing. The process is after he has finished verifying his design.
Is this a fool idea?


Fully vaccinated are you?
That won't fly. Whether design is your product or if it is part of your process, you have to address 4.4.
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