ISO 9001 Scope - Exclusion of Design in an engineered solutions company

[Johnson]

So, just confirming what you're saying here, I can just make a generic/broad form for 7.3.1 that applies to all Jobs (rather than a new one for each Job)? Then just maintain the records of 7.3.2-7 for each Job? For example:

Responsibilites:
1. Aquire Inputs: Design Engineer & Sales
2. Design: Design Engineer & Drafting (and sometimes Customer)
3. Design Review & Verification: Manager of Operations and Operations Manager (and sometimes Customer)
4. Manufacturing: Operations Manager
5. Test (Manufacturing Review, Verification, & Validation): Operations Manager, Test Technician (sometimes Design Engineer & Customer)
6. Maintain Records: Design Engineer

Stages:
Stage 1: Aquire Inputs (PO)
Stage 2: Design (Create BOM & Draft Drawings)
- Review and Verify
Stage 3: Manufacture
Stage 4: Test
- Review, Verify, Validate


Secondly, so it seems what my company does is DEFINITELY design, and the vibe I've gotten is that yes, I CANNOT exclude design. I'm NOT talking about whether it's a good idea or not to exclude it (I've taken your opinions into account and I appreciate them), but whether or not I HAVE to include design. I have read elsewhere in this forum that even if you do design, you do NOT have to include it in your scope if you don't want to, merely that it would be foolish not to do so (as long as you make it clear that your certification does not include Design) or that you can even consider it an outsourced process if you want to exclude it? Again, I'm looking for what is ALLOWED technically, not the wiseness of one course over another; I already know the majority of this forum's stance on that

(The reason I don't seem to care if it is wise or not to exclude design is because I may not be able to convince Top Management that ISO is for us if we have to include design...)

If your organization has design function. You can not exclude it. It is clearly defined in ISO9001. If you exclude it, you are free of related responsibility. I had such experience in one of my former employeer which is ISO/TS16949 certified. In the first 3 years of certification audit, we excluded Design function. But later on the CB noted that we in fact had limited design function. They requested we must include it in the 2nd cycle of certification, otherwise boith CB and we had some issue on the certificate.

 

[Johnson]

Your comment about the design process as you see it is on target.

Your organization IS doing design, they're just reluctant to acknowledge it for fear of having to add complexity to their system.

The good news is, the team is probably ALREADY doing what it needs to do to be compliant. Somebody just needs to map it out, figure out where what's going on aligns with the requirements of the standard, document the whole shebang, enforce it and audit it.

That sounds scarey but it's probably no more work than you're already doing, just done in such a manner that you can prove it's happening to anybody who cares.

And those other companies that are complaining about how meeting the requirements slow them down too much, and inhibit their flexibility? They're either whining because they would whine even if they had no requirements to meet, or somebody designed their systems to be cumbersome.

A well crafted system that meets the requirements of the standard is far more reliable than a poorly crafted variant, and no more work.

Consider this a challenge, and get cracking. Make it your goal to meet the standard by refining your existing system - work with the people involved to make it efficient and effective while adding the absolute bare minimum of burden.

Fully agree !

 

[Ithalion]

If your organization has design function. You can not exclude it. It is clearly defined in ISO9001. If you exclude it, you are free of related responsibility. I had such experience in one of my former employeer which is ISO/TS16949 certified. In the first 3 years of certification audit, we excluded Design function. But later on the CB noted that we in fact had limited design function. They requested we must include it in the 2nd cycle of certification, otherwise boith CB and we had some issue on the certificate.

&

From your descrpition it is a risk to say you can exclude clause 7.3.
Another consideration is to look at your organization chart, it you have department containing "Design","Development", "Engineering" , you may not be able to prove you are free of design responsibility.
I don't think the requirements of 7.3 is difficulty to meet. It only has requiremements like input, output , review, validation, verification etc, but it does not define how do do it. If you have only simple "design " function, then you can simply the process and documentation. If some requirement of ISO9001 was considered as a burden or useless, it may indicate it is not understood the reall meaning of the requirements.

Just for a quick clarification on what you guys said:

I've been definitely convinced that if I was including our whole company in the scope, I would not be able to exclude design. Makes sense. But you're saying that I HAVE to include the engineering department/process in my SCOPE?

I think this is what most have been saying, I had just originally asked because when I was starting in ISO, I had got the impression that your scope could be as limited as you want as long as you make it clear when you post the fact that you're ISO certified; e.g. JUST Manufacturing, or JUST Repair, or JUST Field Service. If you wish. So, regardless of whether or not it's smart (already got plenty of feedback on that ), I thought that I could NOT include the engineering side of things, and thus (with the scope only being things like manufacturing, repair, procurement, field service), it would be true that we do not do design and I could then exclude it.

That had been my impression and that's why I wanted to make it clear that I'm not asking anymore if I could exclude it from a Scope that includes my whole company, just one that contains certain sections of my company (and which does not design the engineering stage).

 

[Johnson]

&


Just for a quick clarification on what you guys said:

I've been definitely convinced that if I was including our whole company in the scope, I would not be able to exclude design. Makes sense. But you're saying that I HAVE to include the engineering department/process in my SCOPE?

I think this is what most have been saying, I had just originally asked because when I was starting in ISO, I had got the impression that your scope could be as limited as you want as long as you make it clear when you post the fact that you're ISO certified; e.g. JUST Manufacturing, or JUST Repair, or JUST Field Service. If you wish. So, regardless of whether or not it's smart (already got plenty of feedback on that ), I thought that I could NOT include the engineering side of things, and thus (with the scope only being things like manufacturing, repair, procurement, field service), it would be true that we do not do design and I could then exclude it.

That had been my impression and that's why I wanted to make it clear that I'm not asking anymore if I could exclude it from a Scope that includes my whole company, just one that contains certain sections of my company (and which does not design the engineering stage).

The "excluding" is really a big topic, even for the ISO9001 committe ISO/TC 176/SC 2 . I attached a document from this committe which inlude the query for this topic.

----------------------------------------------------
Attachment 1 to SC2/N1147
a) Exclusions
The current "exclusions" clause 1.2 in ISO 9001 was originally introduced following the decision to withdraw the ISO 9002 and ISO 9003 standards in 2000. A means had to be found to enable organizations with quality management systems that did not include all of the requirements of ISO 9001:2000 for technical reasons, but which had previously been able to meet the requirements of ISO 9002 or ISO 9003, to be able to claim conformity to the standard. The resulting solution was clause 1.2.
This Committee Draft has taken a different approach to the way in which its requirements are stated, when compared to the earlier editions of ISO 9001; consequently, there should no longer be any technical reasons for an organization's QMS not to be able to meet all the requirements of the future standard. This makes the need for such an exclusions clause redundant. For the time being, this Committee Draft includes text to permit "exclusions" (see lines 387 to 391), but this can be modified depending on the ballot results.
Please review the CD and decide if these requirements need to be maintained, or if they can now be removed. Note that if the results of the ballot indicate that the exclusions clause should no longer be maintained, then this will also require the Design Specification for this revision of ISO 9001 (see document SC2/N1088) to be amended, as Section 3, bullet e) states "The intent of clause 1.2 of ISO 9001:2008 shall be maintained in the revised standard.". This bullet e) would need to be deleted.
----------------------------------------------------------------------

4.3
Determining the scope of the quality management system 375
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.
When determining this scope, the organization shall consider
a)
the external and internal issues referred to in 4.1, and 380
b)
the requirements referred to in 4.2. 381
The scope shall be stated in terms of goods and services, the main processes to deliver them and the sites of the organization included.
When stating the scope, the organization shall document and justify any decision not to apply a requirement of this International Standard and to exclude it from the scope of the quality management system. Any such exclusion shall be limited to clause 7.1. 4 and 8 and shall not affect the organization?s ability or responsibility to assure conformity of goods and services and customer satisfaction, nor can an exclusion be justified on the basis of a decision to arrange for an external provider to perform a function or process of the organization.

 

[AndyN]

&


Just for a quick clarification on what you guys said:

I've been definitely convinced that if I was including our whole company in the scope, I would not be able to exclude design. Makes sense. But you're saying that I HAVE to include the engineering department/process in my SCOPE?

I think this is what most have been saying, I had just originally asked because when I was starting in ISO, I had got the impression that your scope could be as limited as you want as long as you make it clear when you post the fact that you're ISO certified; e.g. JUST Manufacturing, or JUST Repair, or JUST Field Service. If you wish. So, regardless of whether or not it's smart (already got plenty of feedback on that ), I thought that I could NOT include the engineering side of things, and thus (with the scope only being things like manufacturing, repair, procurement, field service), it would be true that we do not do design and I could then exclude it.

That had been my impression and that's why I wanted to make it clear that I'm not asking anymore if I could exclude it from a Scope that includes my whole company, just one that contains certain sections of my company (and which does not design the engineering stage).

Not quite that simple, in that if you DO Product Design, you can't limit the scope to "just" manufacturing, because (obviously or not) design is where "quality" is defined...

 

[Sidney Vianna]

I understand your perspective, however, life is still much easier with the discipline you mention than living with the aftermath when you are not disciplined. MUCH easier.

Many would disagree with that. Exactly because discipline and structure require a conscious effort, many (individual and organizations) don't have it or choose not to exercise it.

In the UK many years ago, unsubstantiated claims that ISO 9001 led to increased business performance was challenged in court and the complainant won: https://isowatch.wordpress.com/2012/12/14/the-case-of-the-vanishing-adjudication/

I guess that, if someone were to advertise that ISO 9001 will make your life easier, that could be challenged as well, as false advertising.

 

[AndyN]

Many would disagree with that. Exactly because discipline and structure require a conscious effort, many (individual and organizations) don't have it or choose not to exercise it.

In the UK many years ago, unsubstantiated claims that ISO 9001 led to increased business performance was challenged in court and the complainant won: https://isowatch.wordpress.com/2012/12/14/the-case-of-the-vanishing-adjudication/

I guess that, if someone were to advertise that ISO 9001 will make your life easier, that could be challenged as well, as false advertising.

In 1997 - the apparent time of the claim and counter claim, that was correct! There were no requirements to be able to show, objectively, what performance was achieved! However, in the post 2000 versions, it CAN be made, (quite reasonably in fact) that implementing ISO 9001 requirements CAN (and does) lead to improved performance!

 

[Big Jim]

Many would disagree with that. Exactly because discipline and structure require a conscious effort, many (individual and organizations) don't have it or choose not to exercise it.

In the UK many years ago, unsubstantiated claims that ISO 9001 led to increased business performance was challenged in court and the complainant won: https://isowatch.wordpress.com/2012/12/14/the-case-of-the-vanishing-adjudication/

I guess that, if someone were to advertise that ISO 9001 will make your life easier, that could be challenged as well, as false advertising.

I have observed countless examples where life became easier as they embraced what an effective QMS could do for them, and also countless examples of the opposite, where ISO 9001 registration was treated like an evil necessity and it was a constant thorn in their side.

Maybe we don't hang around in the same companies.

 

[somashekar]

I am with Jim about 'Life easier' .... If one knows why to do, what to do, when to do, how to do, it makes life that much more easier, which not necessarily is quicker.