Our small company (somehow) got the ISO:9001:1994 certificate even though we had no "design" history.

We are considering excluding it for our 9k2k update.

Can someone provide some "text" examples of how they worded their exclusion.

What happens/what do we need to do if we start to design on a regular basis or a one time basis after certified w/o design?

Is the exclusion stated on the certificate?

Note:
We provide input on customer designs are do not envision designing our "own" products any time soon.

I do not wish to get rid of our "design" forms and documents, but if I can exclude a big chunk, I will.

Thanks in advance
Bob_M

We also give inputs and are involved in the design process, but are not responsible for the design. This is the text that we have in our quality manual:

Design and Development

This section does not apply to the ATS quality system. ATS’ customers are responsible for the control and verification of the design of their product, and therefore this portion is excluded.

Our auditor had no problem with this. Hope this helps.

Thanks Richard. Based on past discussion I know your company is in a similar situation. I did not think the "exclusion" clauses could be so simple. (I'm probably over thinking some of this ISO update stuff and my only references are "passable" 1994 docs.

I did mention dropping design with my boss/company owner recently. He wanted to know what happens if we want/need to design something after being certified w/o design?

What are the risks/problems that are associated with being ISO w/o design if you suddenly NEED or want to design? Simply expand scope and un-exclude during next 3rd party audit?

Like I posted earlier, I LIKE some of our (APQP and QS style) design forms but updating and maintaining a "chunk" of the system we don't use does not seem worth the time. (I may use some of them for RFQ and Product introduction still).

Am I making a bigger deal of this than it needs to be?
Any good real-life and certified design procedures/forms I can view?

Thanks in advance
Bob_M

Alternatively, don't exclude design.
Have a simple procedure for dealing with design.
Tell your external auditor that you're not currently doing design work, but have the allowance there should it be required.
The auditor should verify this as being true.
S/He will then confirm this at each visit, so if design work is done, they can audit it.
No Problem!

David Mullins said:

Alternatively, don't exclude design.
Have a simple procedure for dealing with design.
Tell your external auditor that you're not currently doing design work, but have the allowance there should it be required.
The auditor should verify this as being true.
S/He will then confirm this at each visit, so if design work is done, they can audit it.
No Problem!

Thanks for the feedback.

Your comment also was not a surprise.

Realistically, I'll probably need to keep the "simple" design procedures to keep the boss happy.

Oh Well

THanks Bob_M

You need more surprises in your life.

David Mullins said:

You need more surprises in your life.

No I hate surprises.

Regardless what I expected to "hear" I still need to know:

What happens/what do we need to do if we start to design on a regular basis or a one time basis after certified w/o design?

Regardless what the company choses to do I still need the answer to this question for my boss. *shrug*

Thanks
Bob_M

The best way to answer this might be to talk to your registar. Most of the are pretty cooperative.

I don't know for sure, but I would imagine that you would just add that portion to your system when you start doing design and then the registar would audit the design portion next time they visit.

Hi Bob,

I currently work for a 9001 company that is a spinoff of a company that was 9002 certified.

To upgrade our certification we;

1. informed our registrar of our intent,
2. set up our system to comply with the design requirement, &
3. had Design & Development audited during the next survelliance.

The whole process took a little over 6 months (we had to have evidence of design review) and there were no problems with the registrar. I believe we did have to pay for a new certificate.

Lisa

Bob_M said:

No I hate surprises.

Regardless what I expected to "hear" I still need to know:

What happens/what do we need to do if we start to design on a regular basis or a one time basis after certified w/o design?

Regardless what the company choses to do I still need the answer to this question for my boss. *shrug*

Thanks
Bob_M


Then, as I said before, the auditor will start auditing that "element".
(ou should have audited it internally as well to keep things tidy)

Oh yes, very important point, you need evidence of at least one internal audit of design before going for the upgrade certification.

I'm a bit confused, and I have a hunch you experts out there can help de-confuse me. What is design, for the purposes of ISO 9K2K, anyway? Our corporate office had a consultant who told them we can exclude design, but I don’t clearly understand why.

Let’s say you make a product, say it’s plastic, and you have 100 different plastic compositions each with its own specifications for mechanical strength, color, elasticity, electrical insulating capability, etc. All of these plastics have been designed prior to your ISO effort. Generally, customers come to you and either order your product by saying “send me Product # 77” or “send me product that meets these specifications” and you pick your standard product that meets those specifications.

Scenerio 1: One of your engineers thinks of a better way to make one of these “standard” plastics so that it’s performance is even better than today at a reduced cost. He slightly changes the composition of the plastic (the raw materials used to make it) and maybe a few things in the process, tests it, verifies that it is better than before and does a permanent change to the recipe and process. Did he do design work that needs to be addressed by ISO documentation?

Scenerio 2: A customer comes to you with a need for some plastic and none of your existing products work just right to fit his needs. He asks you to make a plastic similar to a stock plastic, but with greater tensile strength and insulation resistance. Your engineer works on it and indeed creates a modified recipe for a standard plastic to meet the customer’s requirements. Did he do design work that needs to be addressed by ISO documentation?

Scenerio 3: Marketing tells you of a perceived future need for a new plastic, better than anything that exists now. There are no concrete specifications or even orders yet, but you want to be the first on the block with the next big thing. You decide what you think the spec’s. would be for this new super-plastic, do some experiments, and eventually create a new plastic product which you create advertisements for and send to your customers. Did the engineer do design work that needs to be addressed by ISO documentation?

I appreciate any thoughts you might have. :bigwave:

Mike,

I would say that all three scenarios you describe would be consider design and have to be addressed under the standard.

The basic question that I've been told to ask is 'who is responsible for the design'. In the scenarios you've described you are making the design changes. Even though the customer may be asking for something else, they are not specifying the actual design, just the requirements.

Hope this helps and doesn't create more confusion.

Hi Mike,

Based on your three scenarios I have to agree with Richard and say that you are "design responsible" and need to include section 7.3 in your QMS. Also, check out coolpolymers.com. Their material production seems similar to what you describe and I know design is (has to be) part of their ISO 9001:2000 system. Hope this helps.

Lisa

I'm a bit confused, and I have a hunch you experts out there can help de-confuse me. What is design, for the purposes of ISO 9K2K, anyway? Our corporate office had a consultant who told them we can exclude design, but I don’t clearly understand why.


Mike

A member of TC176 who spoke at the European Quality Congress in the UK last year stated that ("in his opinion") more or less every organisation was involved in Design. [This applies to project- and service-based organisations a much as to manufacturing companies.]

Regards

Peter Fraser

I'm a bit confused, and I have a hunch you experts out there can help de-confuse me. What is design, for the purposes of ISO 9K2K, anyway? Our corporate office had a consultant who told them we can exclude design, but I don’t clearly understand why.

Let’s say you make a product, say it’s plastic, and you have 100 different plastic compositions each with its own specifications for mechanical strength, color, elasticity, electrical insulating capability, etc. All of these plastics have been designed prior to your ISO effort. Generally, customers come to you and either order your product by saying “send me Product # 77” or “send me product that meets these specifications” and you pick your standard product that meets those specifications.

Scenerio 1: One of your engineers thinks of a better way to make one of these “standard” plastics so that it’s performance is even better than today at a reduced cost. He slightly changes the composition of the plastic (the raw materials used to make it) and maybe a few things in the process, tests it, verifies that it is better than before and does a permanent change to the recipe and process. Did he do design work that needs to be addressed by ISO documentation?

Scenerio 2: A customer comes to you with a need for some plastic and none of your existing products work just right to fit his needs. He asks you to make a plastic similar to a stock plastic, but with greater tensile strength and insulation resistance. Your engineer works on it and indeed creates a modified recipe for a standard plastic to meet the customer’s requirements. Did he do design work that needs to be addressed by ISO documentation?

Scenerio 3: Marketing tells you of a perceived future need for a new plastic, better than anything that exists now. There are no concrete specifications or even orders yet, but you want to be the first on the block with the next big thing. You decide what you think the spec’s. would be for this new super-plastic, do some experiments, and eventually create a new plastic product which you create advertisements for and send to your customers. Did the engineer do design work that needs to be addressed by ISO documentation?

I appreciate any thoughts you might have. :bigwave:

Mike,

In each of your scenerio's you are faced with with a few possible problems unless some controls are put into place.

Scenerio 1: What is a "better" design in one usage may in-fact be unusable in another. Someone needs to ensure that "all" current uses are given consideration. Additionally, with out controls what is to keep this scenerio from happening in parallel multiples (e.g. more than one engineer making differing modifications to the design of a single product without coordinating these efforts).

Scenerio 2: How does the engineer know that he has met the customer's requirements without a: Understanding/defining the customer's requirements; b: Defining the design characteristics that will be necessary to meet those requirements; c: Reviewing and/or testing the design (or elements of the design) to ensure that the design characteristics/customer requirements are being met; d: Documenting/recording the final design to ensure translation from design to production/creation; e: Testing final product to ensure compliance with the customer's requirements; f: then controlling any necessary revisions/changes. All of which are requirements of 7.3.

Scenerio 3: See my response to Scenerio 2.

ISO 9001:2000 7.3 is not without reason, and should be common sense when it comes to design.

The best way to answer this might be to talk to your registar. Most of the are pretty cooperative.

IMO - good advice. I know I've said it before, but make friends with the technical manager or function at your registrar. I am fortunate that our registrar has a fantastic guy there. I don't call him about every little question, but he has helped me out on a couple of occasions over the last three years.

I had a 7.3 exclusion question come up yesterday with a client. I'd like some opinions about if I handled this the right way...

The company is a custom injection molder. They do not design any parts, and the company does not own any of the tooling (customer property). Sometimes they get involved with part design when customers ask them for help, but the customer is responsible for the finished design. Based on this, I told them that they could exclude 7.3.

Later, I found out that they sometimes build the molds that they use. Some of the work is subcontracted out, such as engineering or some of the tool details, but overall the company is responsible for the tool design. Because they don't own any of the tooling they use, the molds themselves are sold to the customer. Based on this, I told them that they need to include 7.3 in the scope of registration for the design and development of molds. In this case the molds are product sold the customer, even though the customers never actually receive them.

Does this sound reasonable?

Does this sound reasonable?

Yes! I believe that you're right on the money.