Should every Management System include Design?

[Bill Pflanz]

As I have observed here, many auditors feel that have to wait for the standards to catch up. Management systems should not wait for the standards to explicitly specify design of the whole product.

It would take a very progressive manager to agree to expand requirements beyond the standards especially if they are significant changes.

I am not a third party auditor. This frees me to simply ask clients "what other parts of the product are essential for your success?". Often I am told "the standard of our service" I then ask "who is responsible for service design?". I am seeking the subject matter expert as process owner.
These two questions alone may get my clients to think and act differently about design. This part of their product would then be mentioned in the scope of their system. It may not be mentioned in the certification scope.

I fail to see how your questions have anything to do with the design clauses of the standard. Developing processes for your own management system is not design.

Or the third party auditor could ask "Even though you deliver widgets, customer complaints seem to center around service issues. What are you doing to improve the design or execution of your services as this seems to be an important part of your product?".
Getting client's to think about continually improving the parts of their product that differentiate them from their competitors is all that we are talking about.

If there is objective evidence of problems in service area, there are standards that apply to those problems for corrective action. In my opinion, you are unnecessarily adding a complexity into the management system that is not needed.

Bill Pflanz

 

[howste]

An engineer... is asked to design a fire suppression system...

Does this fall into the requirements of 7.3 ?

Yes 7.3 definitely applies. The organization has been asked to design the system. In this case, the system design/specification is the product.

If the customer had already designed the system, and just ordered a list of components from a distributor, then there would be no 7.3 product design required on the distributor's part.

 

[Sidney Vianna]

Let us examine this


An engineer of an organization (ISO 9001:2008 terminology) is asked to design a fire suppression system for the protection of a computer room. The equipment and parts necessary for the assembly of the system already exist.
No new product is designed.

The engineer will have to make all the necessary calculations and draw the system.


Does this fall into the requirements of 7.3 ?

If I understand the scenario you are presenting correctly, the answer would be NO. 7.3 of ISO 9001 deals with the design of the product(s) the organization provides to their customers. So, if the engineer is designing a fire suppression system for a server room (or the like), that falls under the infrastructure part of the ISO 9001 standard. That being the case, ISO 9001 does not require that system to be designed along the requirements of 7.3.

Just because it is not required by ISO 9001, it does not mean that one should not use the process, though.

Again, that is, if I understand the scenario correctly.

 

[John Broomfield]

It would take a very progressive manager to agree to expand requirements beyond the standards especially if they are significant changes.

I fail to see how your questions have anything to do with the design clauses of the standard. Developing processes for your own management system is not design.

If there is objective evidence of problems in service area, there are standards that apply to those problems for corrective action. In my opinion, you are unnecessarily adding a complexity into the management system that is not needed.

Bill Pflanz

Bill,

Thanks for your three observations. Here are my clarifications:

Management system standards limiting the actions of management? In a quarter of a century of use I have only seen the standards used as a set of minimum not maximum requirements.

These questions are about product design not process design. In asking the questions I am seeking the owner of the process for service design so it can be captured as it is. The service design process conforms to clause 7.3 just as a bridge design process would conform to clause 7.3. Service design results in service specifications. Service is an important part of the product and the service specifications enable continual improvement.

Yes, the service standards are also known as service specifications (the output of the service design process per clause 7.3). These are unlikely to come from the customer and may be neglected by the contractor or manufacturer if the registrar focuses only on the design of goods when excluding clause 7.3.

John

 

[Paul Simpson]

Let us examine this


An engineer of an organization (ISO 9001:2008 terminology) is asked to design a fire suppression system for the protection of a computer room. The equipment and parts necessary for the assembly of the system already exist.
No new product is designed.

The engineer will have to make all the necessary calculations and draw the system.


Does this fall into the requirements of 7.3 ?

Just my .

It's very easy to get suckered into the need to ring the full weight of ISO 9001 clause 7.3 requirements just because the word 'design' is used.

Let's be clear the requirement to manage design activities under 7.3 is there because it is seen as being an organization applying processes that are out of the ordinary.

I'd distinguish them with the following criteria:

• A 'one off' customer need (or defined by the organization)
• Needs to be planned to be delivered to the customer schedule
• Requires an 'original' solution
• The outcome of the process is not pre defined at the start

So if the above apply then there is a design element to the work. If not it looks to be more like application of pre existing solutions.

The fire supression exmaple is an interesting one. Here in the UK there is a fire detection certification scheme based on ISO 9001 including design but IMHO the activity is applications engineering with the 'designer' simply choosing standard components based on an established code of practice and calculated room size, layout and usage and hence no design element (again IMHO).

Going back to the OP and poll my short answer is 'No' it shouldn't. You can apply clause 7.3 to process design (it's even mentioned in the note to clause 7.1) but with all of this you need to look at cost / benefit. There is certainly a benefit in having an independent review of 'designed' processes but I'm not sure I'd want my 3rd party CB holding me to a design plan.

I realize of course that this is a case of horses for courses.

 

[Mikelangelo]

If I understand the scenario you are presenting correctly, the answer would be NO. 7.3 of ISO 9001 deals with the design of the product(s) the organization provides to their customers. So, if the engineer is designing a fire suppression system for a server room (or the like), that falls under the infrastructure part of the ISO 9001 standard. That being the case, ISO 9001 does not require that system to be designed along the requirements of 7.3.

Just because it is not required by ISO 9001, it does not mean that one should not use the process, though.

Again, that is, if I understand the scenario correctly.

So it is a matter of interpretation


Is the service (the design) provided by the engineer a subject of 7.3 ?

 

[Mikelangelo]

Yes it does ...

Thank you Someshekar, however, my obvious question is, why?

 

[Sidney Vianna]

So it is a matter of interpretation?

No, it is a matter of application and applicability. As I said, 7.3 of ISO 9001 applies to the INTENDED product. Pay attention to the note in 1.1:

NOTE 1 In this International Standard, the term “product” applies to the product intended for, or required by, a customer or the product realization processes. This applies to any intended output resulting from product realization processes, including purchasing.

If you start enforcing the application of 7.3 to any design related to the plant, where does one stop? Will the landscape be designed in accordance with 7.3?

 

[Mikelangelo]

Yes 7.3 definitely applies. The organization has been asked to design the system. In this case, the system design/specification is the product.

If the customer had already designed the system, and just ordered a list of components from a distributor, then there would be no 7.3 product design required on the distributor's part.

Thank you Howste

Is the system, the product?

The design is done according to the spsecifications of a standard, in this case the NFPA. So in this case, the design is it a "product" or a service?

 

[Mikelangelo]

No, it is a matter of application and applicability. As I said, 7.3 of ISO 9001 applies to the INTENDED product. Pay attention to the note in 1.1:

If you start enforcing the application of 7.3 to any design related to the plant, where does one stop? Will the landscape be designed in accordance with 7.3?

Thank you Sidney Vianna

A company that is engaged in the design of such systems, as described, will it then exclude the 7.3 of its QMS ?