Cove Friend,

can any one tell me what is the rule to decide that Design & Development is Applicable to certain Organization or Not.
:thanx:

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.If the organization does design and development of product, it must include it in the scope of the system.

For more information on exclusions see
Guidance on ISO 9001 Sub-clause 1.2 'Application' (http://isotc.iso.org/livelink/livelink/3554792/1.2Application.doc?func=doc.Fetch&nodeid=3554792)
For other guidance documents see here
http://isotc.iso.org/livelink/livelink/fetch/2000/2122/138402/755901/1069636/customview.html?func=ll&objId=1069636&objAction=browse&sort=name

If the organization does design and development of product, it must include it in the scope of the system.

Don't forget that there is also partial exclusion to design. To claim all of 7.3 as an exemption a company cannot perform design or participate in design. If they participate in their customer's design but do not otherwise perform design, they need to claim partial design.

Don't forget that there is also partial exclusion to design. To claim all of 7.3 as an exemption a company cannot perform design or participate in design. If they participate in their customer's design but do not otherwise perform design, they need to claim partial design.

What do you mean by participate in their customer's design?

If the customer has design authority and the organization only provides input, then the org. can still exclude design. For design to apply, the organization would need to have some authority to implement or change change product designs. Giving advice to customers is not the same as having design authority.

Don't forget that there is also partial exclusion to design. To claim all of 7.3 as an exemption a company cannot perform design or participate in design. If they participate in their customer's design but do not otherwise perform design, they need to claim partial design.

Not true, Jim. You can't get registered to ISO 9001 including design - unless you have design change authority!

Having input to a customer's design process is nice (a 'mutually beneficial supplier relationship) but it won't allow you to claim design in your scope! Sorry!

If you have experience where a CB had approved a scope like that, then a complaint to ANAB is in order........

Claiming exclusions is not limited to the entirety of an element.

Design responsibility is not the defining factor as to if you have design involvement. Design involvement is the defining factor.

Making suggestions to customers that may change design is design involvement. You are participating in their design inputs.

If you are involved with any part of design, you need to own up to it and define it in your scope of registration.

From 1.2 "Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion."

If you are partially involved in design, how can you claim the entirety of it as an exclusion?

Claiming exclusions is not limited to the entirety of an element. That is correct. Design responsibility is not the defining factor as to if you have design involvement. Design involvement is the defining factor.

Making suggestions to customers that may change design is design involvement. You are participating in their design inputs. That is totally incorrect.

Claiming exclusions is not limited to the entirety of an element.
True, you can claim exclusion from part of a clause.
Design responsibility is not the defining factor as to if you have design involvement. Design involvement is the defining factor.
No, design authority is.
XYZ Electronics was justified with its decision to exclude sub-clause 7.3 Design and development from its QMS since it does not have any authority or accountability for design...

True, you can claim exclusion from part of a clause.

No, design authority is.

That case does not address partial design.

Not true, Jim. You can't get registered to ISO 9001 including design - unless you have design change authority!

Having input to a customer's design process is nice (a 'mutually beneficial supplier relationship) but it won't allow you to claim design in your scope! Sorry!

If you have experience where a CB had approved a scope like that, then a complaint to ANAB is in order........


I also agree with AndyN

For exapmle -The product drawings are given to various suppliers for manufacture of parts.

The Drawing title block at the bottom gives the details of the owner of the design-Drawn by,Checked by & Approved by(Design authority).
The customer here is the Design & change authority.
This company who is the customer for various suppliers cannot claim exclution from D&D

But those suppliers manufacturing parts as per that drawing can claim exclution from D&D(7.3)

Why not talk about the real technical activity on the daily of your company Varadarajan?

Do you participate on the design process of the related products? do you edit drawings on your behavior?

Do you deal with specifications at the entry of the process?

don't let us scaring you with responsabilities or strong theory...

the answer is on your desk and shelves.

;)

Why not talk about the real technical activity on the daily of your company Varadarajan?

Do you participate on the design process of the related products? do you edit drawings on your behavior?

Do you deal with specifications at the entry of the process?

don't let us scaring you with responsabilities or strong theory...

the answer is on your desk and shelves.

;)

Thats good,
I will give all the details while I was a designer for Fuel pumps for Diesel engines for various Euro & US customers.

I was at R & D / BOSCH WORKS AT BANGALORE -INDIA

The answer is yes for most of them.


I am leaving urgently, I will get back to you.

Varadarajan

That case does not address partial design.

Please explain what you mean by partial design.

If you mean that the organization has some authority to change the design without customer approval, then they must include 7.3 in their scope. If they have no authority to change the design, even if they provide advice to their customer, then 7.3 should be excluded.

Jim:

Are you thinking TS 16949, where an organization, although not responsible for product design, must still include process design within its QMS?

If not, then I'm afraid it'll be a long day before you can convince 98% of the world that an organization having some input to anothers product design process, allows that (first) organization to claim responsibility for 'design' in their scope. Are you seriously suggesting that if a supplier is invited to particiapte in a design review at a customer, they can have 'design' on their certificate?

My parent company NTS, is a network of labs who have the (extensive) ability to perform design validation testing for their clients. Does that mean the lab can claim 'design' on their certifications?

Jim:

Are you thinking TS 16949, where an organization, although not responsible for product design, must still include process design within its QMS?

If not, then I'm afraid it'll be a long day before you can convince 98% of the world that an organization having some input to anothers product design process, allows that (first) organization to claim responsibility for 'design' in their scope. Are you seriously suggesting that if a supplier is invited to particiapte in a design review at a customer, they can have 'design' on their certificate?

My parent company NTS, is a network of labs who have the (extensive) ability to perform design validation testing for their clients. Does that mean the lab can claim 'design' on their certifications?



I think you may be mixing design (7.3) with planning for production (7.1). Companies can perform activity, including engineering, to determine how to produce something without impinging on design. Looking further at one of the notes for 7.1, "The organization may also apply the requirements given in 7.3 to the development of product realization processes." This can be done without altering design.

Not really, Jim. TS is very specific, you can't exclude design - for processes - are you familiar with these requirements?

Whenever I hear these odd theories and proposals, I always think where does the idea come from. The idea of an organization giving suggestions as design input allowing them to claim design in their scope statement, although original, is nonsensical.

It might be connected with organizations that typically don't have design processes in their system, such, as e.g., build to print machine shops, foundries, forging houses, etc..., but want to use their ISO 9001 certificate as a form of marketing and, by (nonsensically) including design, they claim to be a notch up their competitors. I have seen cases like that in the past. Obviously, the misleading registrant would have to find a CB that would go along with such misapplication of the standard.

It is amazing how some ideas get propagated.

Not really, Jim. TS is very specific, you can't exclude design - for processes - are you familiar with these requirements?

No, I don't work with TS.

Dear Sidney Vianna

Agreed ! but i want slight differnt view, actually design applicablity can be judge by understanding actual application onsite , that is why iso certification process of Two stages in the first stage ( pre audit) one has to check .

What is your opinion about foundry/ melter where organization changes material composition they mixup material and make the different application and Customer are not aware about chemistry then what?

what design applicability ?.

Dear Sidney Vianna

Agreed ! but i want slight differnt view, actually design applicablity can be judge by understanding actual application onsite , that is why iso certification process of Two stages in the first stage ( pre audit) one has to check .

What is your opinion about foundry/ melter where organization changes material composition they mixup material and make the different application and Customer are not aware about chemistry then what?

what design applicability ?.

Mixing materials to get different characteristics/chemistry isn't 'design'! This is not new material or changed material. The customer may not be aware of the chemistry but they do order a grade or specification, (in even basic terms) and the blending of raw materials to achieve that grade isn't considered to be 'design' - sorry!

ISO 9001 clause 1.2

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.


Refer above , if chemical or chemistry changes in its effect the final products application or requirements and final products performance got effected then claim of exclusion not is acceptable and organization is responsible for design

Look at pharm /medical : where whole RD is on the base Formulation , in change in chemical composition by PPM whole performace of final medicine got changed

Sorry!!!! design is creativity / innovation can be done :argue:

Refer above , if chemical or chemistry changes in its effect the final products application or requirements and final products performance got effected then claim of exclusion not is acceptable and organization is responsible for design If a supplier changes the formulation/chemical composition/metallurgy of a product WITHOUT conferring with the customer, who has design authority, they should be penalized and subjected to criminal prosecution; not given design responsibility rights.

In some cultures, suppliers believe that they can adulterate products without customer formal consent. Not only that is unethical and possibly criminal, but exactly THE OPPOSITE of what ISO 9001 prescribes.

ISO 9001 clause 1.2

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.


Refer above , if chemical or chemistry changes in its effect the final products application or requirements and final products performance got effected then claim of exclusion not is acceptable and organization is responsible for design

Look at pharm /medical : where whole RD is on the base Formulation , in change in chemical composition by PPM whole performace of final medicine got changed

Sorry!!!! design is creativity / innovation can be done :argue:

I'm well aware of what the standard says regarding exclusions! I'd appreciate you not doing that! Your premise is fundamentally incorrect. You're wrong to suggest that 'creativity/innovation can be done. Here in the USA consumers have seen the effects of producers in other countries who are 'creative' and 'innovative' in changing fundamental characteristics - often to save money - with disastrous effects. As Sidney says, it's illegal, immoral and just plain wrong!

Your suggestions won't work in the Western world and if we are in a global economy, you will have to revise your thoughts about this topic, since the precedents have already been set! No more arguements, please!

Mixing materials to get different characteristics/chemistry isn't 'design'! This is not new material or changed material. The customer may not be aware of the chemistry but they do order a grade or specification, (in even basic terms) and the blending of raw materials to achieve that grade isn't considered to be 'design' - sorry!

I think I see where you are coming from. Foundries check the composition of the melt before they pour. If the check shows that the material in the melt does not meet spec, they add ingredients as needed until it is in spec, checking as many times as needed. This activity would not be design as long as what they are doing is to make sure that they are meeting the customer requirement.

If, however, the foundry took it upon themselves to alter the formula just because they thought they could improve what the customer asked for, they have crossed the line in several ways. They may have moved into design. They have also viotlated their customer's trust to suppply what was specified.

Thanks for healty discussion,
I involved to puts my view as open forum , I have total respects of your views and defintley I got some insight about discussion.
But discussion is going to wards othe way,forum is not use to blame hence i drop my self ....



Thanks to all

I've seen a copy of a registrar's confidential internal document (I've been asked to not disclose the name of the registrar) that has the exact interpretation that Big Jim has stated above. It states that if the organization gives input to customer design, even if they don't have the final authority, then they cannot exclude design from the scope of their system.

I don't believe that it's a correct interpretation. I think having design listed on such certificates would be misleading to customers of the organizations.

BTW, this is not a registrar that I audit for...

please explain what you mean by partial design.

If you mean that the organization has some authority to change the design without customer approval, then they must include 7.3 in their scope. If they have no authority to change the design, even if they provide advice to their customer, then 7.3 should be excluded.

Howste,

your reply is convincing to me, but can I claim a case for Painting Manufacturing company with R&D department, which involve in inventing new types of products ( new colors, or new types of paints for different usage), at this case, they have authority to change in the contents without refering to customers, but, they should not exceed the Legal specifications.
how do you thing such case should be? I mean including 7.3 or NOT
:thanks:

If you are designing different formulations of paint which are being sold as commercial off-the-shelf products, then I believe you must include 7.3.

If you are designing different formulations of paint which are being sold as commercial off-the-shelf products, then I believe you must include 7.3.

I feel it should be excluded, as in any type of business, you can not go out beyond the limitation of specifications (legal.. local or International), and you have limitation of developments, or new invents in your products conditioning that you shouldn't deviate off these boundaries.

please, comments:D

I don't believe that it's a correct interpretation. I think having design listed on such certificates would be misleading to customers of the organizations.I agree with you. The registrar with such flawed (in my opinion) advisory would then proceed to charge more for the audit, since the organization can not claim design as an exclusion...:notme:

Such a notion is really bizarre - to exclude every part of 7.3, with the exception of design review and be able to claim design responsibility?

I wonder if it could be the same CB who had an auditor visit the engineering center of a company (world renowned for their product designs) and actually write the design exclusion for them.......:mg:

I hope this doesn't change the subject too much, but I have a question regarding designs. I posted this in the ISO 13485 section, but have not received a response.

The question I have is: Does design only apply to "products"? Let me explain... I performed a supplier audit and the supplier performs a service for us. Without revealing too much information. The company is registered to 13485 and ON THEIR CERTIFICATE it says "The design of --- validation programs". The certifcate is a corporate document and not all the companies perform the design service. The dilemma is that in their quality manual it states that their company is exempt from design requirements because they don't perform design.

My question: Does design pertaint even if it is for services provided, especially since it is mentioned on their certificate?

Thank-you!!

I feel it should be excluded, as in any type of business, you can not go out beyond the limitation of specifications (legal.. local or International), and you have limitation of developments, or new invents in your products conditioning that you shouldn't deviate off these boundaries.

please, comments:D

In this situation, the company is still doing design. The regulatory body isn't doing design, the company is.

I agree with you. The registrar with such flawed (in my opinion) advisory would then proceed to charge more for the audit, since the organization can not claim design as an exclusion...:notme:

I don't get involved with the billing so I cannot respond with certanty, but from what I understand the billing is according to the complexity of the audit, and partial design, particualrly just design review and design inputs, would not take nearly as long to audit as full disign. In fact, it may not take any more time at all.

Howste,

your reply is convincing to me, but can I claim a case for Painting Manufacturing company with R&D department, which involve in inventing new types of products ( new colors, or new types of paints for different usage), at this case, they have authority to change in the contents without refering to customers, but, they should not exceed the Legal specifications.
how do you thing such case should be? I mean including 7.3 or NOT
:thanks:

I feel it should be excluded, as in any type of business, you can not go out beyond the limitation of specifications (legal.. local or International), and you have limitation of developments, or new invents in your products conditioning that you shouldn't deviate off these boundaries.

please, comments

You have basically answered your own question. I have placed my emphasis in bold. So, in my opinion, you cannot exclude 7.3

You are designing the paint that includes the colors and chemical composition, to add to your market. That is considered "Design" of the paint.

Now, if you were to change the composition or color of a paint that the Customer specifically ordered, than you would be violating the Purchase Order/Contract. You have knowingly changed the color, and the composition, without the Customer's approval. That is unethical/illegal, especially for Aerospace Customer, that the change could cause a chemical reaction/change in the material that it was applied to, therefore, I would not suggest doing that for one of Customers, in my opinion.

I don't get involved with the billing so I cannot respond with certanty, but from what I understand the billing is according to the complexity of the audit, and partial design, particualrly just design review and design inputs, would not take nearly as long to audit as full disign. In fact, it may not take any more time at all.

I can see it now - "Register with Us (name withheld) and You can Get Design for no extra Charge......":notme::rolleyes:

I can see it now - "Register with Us (name withheld) and You can Get Design for no extra Charge......":notme::rolleyes:

Not likely.

I know that they do charge more for full design. I also know that when one client asked about the difference for going from no design to partial design, they were not big enough to have tripped any additional charges.

Beyond that I don't have enough knowledge to comment.

I also know that when one client asked about the difference for going from no design to partial design, they were not big enough to have tripped any additional charges.

Beyond that I don't have enough knowledge to comment.Do any of your clients has an ISO 9001 certificate with the scope of certification such as:

The partial design and manufacture of gadgets?

I have not seen partial design in the scope statement.

Edit: Although I have not seen partial design in the scope statement on the certificate, it is part of the scope statement in the quality manual with the justification for exclusions.

I am sorry I cannot agree with Big Jim.

Participating in customer's design reviews/meetings or giving advice to the customer does not constitute or imply responsibility for the whole or a part of the design process. You are only assisting the customer by giving suggestions/design inputs that the customer may or may not find acceptable fully or partially in his overall view of the design process. The ultimate responsibility for the design remains with the customer. You have no responsibility for any of the subclauses of 7.3 either.

I am sorry I cannot agree with Big Jim.

Participating in customer's design reviews/meetings or giving advice to the customer does not constitute or imply responsibility for the whole or a part of the design process. You are only assisting the customer by giving suggestions/design inputs that the customer may or may not find acceptable fully or partially in his overall view of the design process. The ultimate responsibility for the design remains with the customer. You have no responsibility for any of the subclauses of 7.3 either.


Agree of don't, but that is the position of at least one major CB.

And if you really think about it, it does make sense. The standard does not say anything about who is responsible for design. It only talks about design activity. If you participate in design, you should not be claiming full exemption.

Agree of don't, but that is the position of at least one major CB.

And if you really think about it, it does make sense. The standard does not say anything about who is responsible for design. It only talks about design activity. If you participate in design, you should not be claiming full exemption.

Maybe it makes sense to the one CB, 'major' (whatever that means) or not. Plenty of clients would love to have the word "design" appear in their scope (for no extra cash), but that doesn't make it an appropriate scope or certification!

Based on what all the other CB's do, it doesn't makes sense to them, clearly.......and I rather doubt the customers of an organization claiming 'partial design' would be impressed, either!

I'd suggest that the tie breaker would be the limitation of culpability in a mega buck product liability law suit, where the product design was found to be at fault! I bet you wouldn't see a lot of 'partial design' suppliers for dust........

Maybe it makes sense to the one CB, 'major' (whatever that means) or not. Plenty of clients would love to have the word "design" appear in their scope (for no extra cash), but that doesn't make it an appropriate scope or certification!

Based on what all the other CB's do, it doesn't makes sense to them, clearly.......and I rather doubt the customers of an organization claiming 'partial design' would be impressed, either!

I'd suggest that the tie breaker would be the limitation of culpability in a mega buck product liability law suit, where the product design was found to be at fault! I bet you wouldn't see a lot of 'partial design' suppliers for dust........

It only shows up in the exclusion statement. It does not show up on the certificate.

I guess you must feel that it is OK to claim exemption to design when a company is involved with design?

Take another look at 1.2

"Where any requirements(s) cannot be applied due to the nature of an organization and its product, this can be considered for exclusion."

If a company is involved in design, how can they claim it for exclusion?

". . . and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements."

Some of my partial design clients feel that they would compromise their ability to provide product that meets their customer expectations.

My partial design clients tell me that their customers ARE impressed that they are willing to make suggestions when they see opportunities for improvement.

I believe that there is so much resistance to this concept is that it runs contrary to your experience, but if you stop and read the standard you can see that it is appropriate.

I believe that there is so much resistance to this concept is that it runs contrary to your experience, but if you stop and read the standard you can see that it is appropriate.That reminds me of the joke:
As a senior citizen was driving down the freeway, his car phone rang. Answering, he heard his wife's voice urgently warning him, "Herman, I just heard on the news that there's a car going the wrong way on 280. Please be careful!"

"Hell," said Herman, "It's not just one car. It's hundreds of them!"
Once and for all: The standard is about design responsibility, not design involvement. When ALL CB's but one agree on something, it should give you a hint.

It only shows up in the exclusion statement. It does not show up on the certificate.

I guess you must feel that it is OK to claim exemption to design when a company is involved with design?

Take another look at 1.2

"Where any requirements(s) cannot be applied due to the nature of an organization and its product, this can be considered for exclusion."

If a company is involved in design, how can they claim it for exclusion?

". . . and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements."

Some of my partial design clients feel that they would compromise their ability to provide product that meets their customer expectations.

My partial design clients tell me that their customers ARE impressed that they are willing to make suggestions when they see opportunities for improvement.

I believe that there is so much resistance to this concept is that it runs contrary to your experience, but if you stop and read the standard you can see that it is appropriate.

At what point does "partial design" become a factor? If a job shop excludes design responsibility from their QMS scope, and they get a call one day from a customer's design engineer asking about whether a given dimensional tolerance is realistic, is the shop "partial design" responsible? Tell us where the line is between no design responsibility and "partial" design responsibility.

Where the line actually is in authority for developing new designs, and changing old ones. If you can't unilaterally change a product design, you're not design responsible.

That reminds me of the joke:

Once and for all: The standard is about design responsibility, not design involvement. When ALL CB's but one agree on something, it should give you a hint.

Not all models are perfect, but most are useful. Your model doesn't fit.

Another model that doesn't fit is "if salmon didn't swim upstream, there would be no salmon".

At what point does "partial design" become a factor? If a job shop excludes design responsibility from their QMS scope, and they get a call one day from a customer's design engineer asking about whether a given dimensional tolerance is realistic, is the shop "partial design" responsible? Tell us where the line is between no design responsibility and "partial" design responsibility.

Where the line actually is in authority for developing new designs, and changing old ones. If you can't unilaterally change a product design, you're not design responsible.

I have not encountered something as trivial as that yet. If I do, I'll call the CB and ask what they want to do.

A job shop that routinely makes suggestions on how to improve design when they review specifications are indeed participating in design. If it is a rare event, and I came accross it, I would talk to the CB.

I have not encountered something as trivial as that yet. If I do, I'll call the CB and ask what they want to do.

A job shop that routinely makes suggestions on how to improve design when they review specifications are indeed participating in design. If it is a rare event, and I came accross it, I would talk to the CB.

I would suggest that if it's necessary to make a call 'back to base' for an auditor to determine what's in scope or not indicates a fundamental accreditation issue. I have heard from others about having to seek this kind of sanctioning from 'HQ' and found that it's often incosistently applied.

I'd be interested to know what ANAB, UKAS and RvA would answer if they were questioned about the validity of certification based on 'partial design'.......

As Sidney says, Jim, if this is such a great idea, that it's a reasonable interpretation of 'design responsibility', how come the more experienced, longer serving CB's (I'm guessing yours isn't one of the earlier CB's to be accredited) haven't be doing what you propose?

I have not encountered something as trivial as that yet. If I do, I'll call the CB and ask what they want to do.

A job shop that routinely makes suggestions on how to improve design when they review specifications are indeed participating in design. If it is a rare event, and I came accross it, I would talk to the CB.

The question isn't about participating in design--if that were the case, there would be no exclusions for job shops, ever. You yourself have just characterized a hypothetical instance of "design participation" as "trivial." :cool:
I don't care what a single misguided CB says--it's about design responsibility, not design participation. In your view of "partial" design participation, a job shop would have to refuse all requests for information related to design from their customers in order to maintain an exclusion. That makes no sense on any level.

I would suggest that if it's necessary to make a call 'back to base' for an auditor to determine what's in scope or not indicates a fundamental accreditation issue. I have heard from others about having to seek this kind of sanctioning from 'HQ' and found that it's often incosistently applied.

I'd be interested to know what ANAB, UKAS and RvA would answer if they were questioned about the validity of certification based on 'partial design'.......

As Sidney says, Jim, if this is such a great idea, that it's a reasonable interpretation of 'design responsibility', how come the more experienced, longer serving CB's (I'm guessing yours isn't one of the earlier CB's to be accredited) haven't be doing what you propose?

This isn't my intrepretation. It is the intrepretation of the CB that I work with. I only apply it as directed.

The standard does not use the term "design responsible". That term is an intrepretation. Why are you so shocked that their could be other intrepretations?

The question isn't about participating in design--if that were the case, there would be no exclusions for job shops, ever. You yourself have just characterized a hypothetical instance of "design participation" as "trivial." :cool:
I don't care what a single misguided CB says--it's about design responsibility, not design participation. In your view of "partial" design participation, a job shop would have to refuse all requests for information related to design from their customers in order to maintain an exclusion. That makes no sense on any level.

You are right, there should be no exception. Job shops that participate in design should not be able to claim the entirety of 7.3 as an exclusion. The call to headquarters would happpen if the auditee protested the finding. This speaks to the scope of registration and the CB needs to be informed when something is found that is in conflict to the agreed scope.

Do you not contact the CB when you find a varience from the stated scope statement?

You are right, there should be no exception. Job shops that participate in design should not be able to claim the entirety of 7.3 as an exclusion. The call to headquarters would happpen if the auditee protested the finding. This speaks to the scope of registration and the CB needs to be informed when something is found that is in conflict to the agreed scope.

Do you not contact the CB when you find a varience from the stated scope statement?

A CB that insists on this kind of silliness would never have gotten my business to begin with.

A CB that insists on this kind of silliness would never have gotten my business to begin with.

It seems like I heard the same comments when we were told to start doing process based auditing and quite relying entirely on a checklist. Also when were were told to start asking clients how their processes were performing based on the KPI.

I still don't see an answer to the question about why no-one but your CB does this Jim? The CB you work for, if this is their formal documented approach to certification to ISO 9001 is completely out of step with the market.

I'm also interested to know that if you audit companies who participate in partial design activities, are you checking to see if their participants are competent to do this? What types of records of participation do they have to keep? Are they internally auditing this design activity? Is it reported at management review? Do they have any quality objectives tied to the partial design activity? How do they work to improve this?

Your answers are eagerly awaited!

BTW - Let's not trade terminology about responsibility for design since the word is used in context of 1.2 of the standard, regarding exclusions!

What puzzles me: Big Jim seems to believe that the CB in question is 100% correct in their interpretation; so why not PROUDLY disclose the CB's identity here? What are we hiding? If we are so much smarter than the competition, I would like potential clients to know who I am, so they flock in droves to my services.

Such an unorthodox and creative interpretation should be publicly displayed in their website and available to other interested parties.

I still don't see an answer to the question about why no-one but your CB does this Jim? The CB you work for, if this is their formal documented approach to certification to ISO 9001 is completely out of step with the market.

I'm also interested to know that if you audit companies who participate in partial design activities, are you checking to see if their participants are competent to do this? What types of records of participation do they have to keep? Are they internally auditing this design activity? Is it reported at management review? Do they have any quality objectives tied to the partial design activity? How do they work to improve this?

Your answers are eagerly awaited!

BTW - Let's not trade terminology about responsibility for design since the word is used in context of 1.2 of the standard, regarding exclusions!

Oh but let us do look at 1.2.

Responsibility is a word used there, but not in the context of being responsible for design. In context it is used in the context of providing product that meets customer requirements.

" . . . and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements."

As for what I look for in companies that claim partial design, it depends on what portion of design they claim to participate in. If they claim to make suggestions when they discover either opportunities for improvement or mistakes when reviewing customer specifications, that is where I look.

I have no idea why other CB's don't include partial design in their registration scheme. Perhaps you should ask them.

I have no idea why other CB's don't include partial design in their registration scheme. Perhaps you should ask them.Probably because we understand the intent and proper application of the standard?

Look at this document (http://www.anab.org/HTMLFiles/docs/Aps/FA2007-AS9110ap.pdf). It is an application form for CB's that want to attain AS9110 accreditation from ANAB.



Section 5 – Initial Witness Assessment
(reference: AS9104, 5.3)

A full system AS9110 assessment at a suitable organization is required to be witnessed by ANAB. An upgrade from AS9100 to AS9110 (per AS9104, 8.2.5) is not considered a suitable audit for ANAB to witness for AS9110 initial accreditation.
A suitable organization may be design responsible and shall be subject to prime contractor flowed-down requirements or to FAA Requirements (Title 14 CFR Part 21 or 145).
Note: If a design responsible organization is not available, an organization that is not design responsible may be used, however the scope of accreditation will be limited to AS9110 for non-design responsible organizations until such time as ANAB has witnessed the CB assessing the design control processes of a suitable organization’s quality system.




Do you read where it says design responsibility? It does not state design involvement. Your CB interpretation is simply stupid. If I participate in a focus group suggesting to Volkswagen what new features I would like to see in a car, does that make me part of VW's design team? NO. ISO 9001 requires the organization RESPONSIBLE for the product design to evaluate inputs to determine their adequacy. Just because someone suggests something, it does not mean that they are part of the design team or process.

Let's go: name the CB. Why would they be concerned of being associated with such interpretation, if it is so brilliant?

What puzzles me: Big Jim seems to believe that the CB in question is 100% correct in their interpretation; so why not PROUDLY disclose the CB's identity here? What are we hiding? If we are so much smarter than the competition, I would like potential clients to know who I am, so they flock in droves to my services.

Such an unorthodox and creative interpretation should be publicly displayed in their website and available to other interested parties.

Sidney,

I would prefer to respond to you privately, but your private message feature has been turned off. So I guess that I will not be able to respond.

I have learned a lot while participating here at the Cove. You are one of the contributors that I have found most helpful. I am not trying to flaunt a unique intrepretation, I have only defended it once it came up.

Probably because we understand the intent and proper application of the standard?

Look at this document (http://www.anab.org/HTMLFiles/docs/Aps/FA2007-AS9110ap.pdf). It is an application form for CB's that want to attain AS9110 accreditation from ANAB.



Do you read where it says design responsibility? It does not state design involvement. Your CB interpretation is simply stupid. If I participate in a focus group suggesting to Volkswagen what new features I would like to see in a car, does that make me part of VW's design team? NO. ISO 9001 requires the organization RESPONSIBLE for the product design to evaluate inputs to determine their adequacy. Just because someone suggests something, it does not mean that they are part of the design team or process.

Let's go: name the CB. Why would they be concerned of being associated with such interpretation, if it is so brilliant?

Sidney,

Why would you go back and edit your post so it has a very different question than the one I already answered?

I looked at the web site for the CB that you are associated with. I did not find anything about design or no design concerning registration. So you expect other CBs to live to a higher standard?

Clause 4.1 of ISO 9001 requires that we determine and control our QMS processes. If we have no authority for design, we have no control either.

Going back to the guidance document on the ISO website, in one of the examples it says: XYZ Electronics was justified with its decision to exclude sub-clause 7.3 Design and development from its QMS since it does not have any authority or accountability for design of the mobile phone product. Its customer provides the design.(my emphasis)

I would prefer to respond to you privately, but your private message feature has been turned off. So I guess that I will not be able to respond.This conversation is public. As you know, I know what CB you work for. I just think it would be enlightnening for the rest of the covers and the world at large to know that too. I have learned a lot while participating here at the Cove. You are one of the contributors that I have found most helpful. I am not trying to flaunt a unique intrepretation, I have only defended it once it came up.Thanks for the compliment. One of my goals at the Cove is to share knowledge and warn people about misinformation. That is exactly what I am trying to do here. I have even voiced my strong disagreement with some of the "official" TC176 interpretations.Sidney,

Why would you go back and edit your post so it has a very different question than the one I already answered? What are you referring to? I added the word "me" to the post when I realized it was missing. I looked at the web site for the CB that you are associated with. I did not find anything about design or no design concerning registration. So you expect other CBs to live to a higher standard?Good way of attempting to deflect the issue, Jim. If you have certainty about the adequacy of this interpretation, why don't you name the CB behind it? People are starting to get curious. Actually, that CB has several "Covevoyeurs". I would not be surprised if you get a call from someone there, who will tell you: Drop this exchange or else.

This conversation is public. As you know, I know what CB you work for. I just think it would be enlightnening for the rest of the covers and the world at large to know that too. Thanks for the compliment. One of my goals at the Cove is to share knowledge and warn people about misinformation. That is exactly what I am trying to do here. I have even voiced my strong disagreement with some of the "official" TC176 interpretations. What are you referring to? I added the word "me" to the post when I realized it was missing. Good way of attempting to deflect the issue, Jim. If you have certainty about the adequacy of this interpretation, why don't you name the CB behind it? People are starting to get curious. Actually, that CB has several "Covevoyeurs". I would not be surprised if you get a call from someone there, who will tell you: Drop this exchange or else.

When I originally commented on Partial Design, I had no idea that it was not more commonly accepted. I never expected this to become such a volatile thread.

Sidney, in spite of which CB I work with, I have extended the olive branch. I have extended it on my behaf, not theirs. It is up to you if you want to accept it or not. If you have a problem with that CB, take it out on them, not me.

If you have a problem with that CB, take it out on them, not me.I don't have a problem with anyone or anything other than wrong ideas being mis-promoted. The CB in question is not promoting it. From all that I know, that advisory might be rescinded or not enforced any longer. You, Jim, is the one that has been trying to convince us that the interpretation makes sense. And several people, including myself, have expressed opposing views.

For a positive Cove experience, it is imperative that people understand that we must be able to disagree (sometimes vigorously) over ideas, but, and to the extent which is possible, don't take the opposing views as personal attacks.

I don't have a problem with anyone or anything other than wrong ideas being mis-promoted. The CB in question is not promoting it. From all that I know, that advisory might be rescinded or not enforced any longer. You, Jim, is the one that has been trying to convince us that the interpretation makes sense. And several people, including myself, have expressed opposing views.

For a positive Cove experience, it is imperative that people understand that we must be able to disagree (sometimes vigorously) over ideas, but, and to the extent which is possible, don't take the opposing views as personal attacks.

I will accept that you and I have agreed to disagree.

Big Jim and Sidney,

I have followed this thread with great interest. Both of you gentlemen are to be commended for your professional behavior and great posts in this thread. You show that professionals can have strongly opposing viewpoints and have a meaningful dialogue about it. I am impressed. :agree1:

Stijloor.

I have never even heard of anything called 'partial design' let alone come across it.

I am kind of 'gobsmacked' at the idea of 'involvement' somehow enabling something called 'partial design' to be 'included in the scope'. How this could be seen as acceptable is quite beyond me. (And this isn't a personal attack, Jim, but it is a very strong refutation of that particular position.)

The key point is who has responsibility for the design and authority to create and/or change it.

Sure, they may involve other people in that.

But no, I don't accept for one single millisecond the idea that any of those other parties could claim 'partial design' (whatever that is supposed to be). No, no and no again.
:nope: :nope:

Big Jim and Sidney,

I have followed this thread with great interest. Both of you gentlemen are to be commended for your professional behavior and great posts in this thread. You show that professionals can have strongly opposing viewpoints and have a meaningful dialogue about it. I am impressed. :agree1:

Stijloor.

I disagree. :tg:

I disagree. :tg:

????????:confused:

????????:confused:

:):D:tg:

Here in the Series of Tubes when you see a "smiley" symbol such as the three shown above it should be taken as a hint that what preceded it might not have been intended to be taken seriously.