Scope Definition - Scope of ISO 9001 Registration

[Sidney Vianna]

:mg: I cannot believe what I am reading from the others posters!:mg: (OK, I am a little harsh on you guys here! My bad!)

- To quote the ISO 9001:2008 standard, clause 1.2: "all requirements of this international standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided".
- To quote Webster's dictionary: an organization is "an administrative and functional structure; the personnel of such a structure".
- Nowhere in the standard is written that the requirements shall apply to the whole company

Put the three together and the conclusion is: IT IS UP TO THE ORGANIZATION TO DEFINE THE SCOPE OF THE REGISTRATION.

This means that a company can define its scope of registration to be limited only to the manufacturing part of the business or any other parts that it wants registered. This is done every day in many industries and by many corporations. Do you think that Ford or GM or Chrysler have only one registration certificate and only one scope?!? Think again! The common practice is to register major departments and plants as stand alone 'organizations' with their own certificates.

So, to get back to the OP's question, you can define the scope of registration as you wish. If you chose to exclude R&D then let it be so! Heck, you can exclude half of your manufacturing if you choose. Keep in mind that R&D could still be regarded as a 'supplier' and/or a 'customer' to the manufacturing organization, depending on how the two interract and fit in the corporate puzzle. I suggest that you consult with your registrar of choice to ensure that the scope is worded adequately and don't let them talk you into something you don't want to do. Ask "where is it written or sanctioned?" before accepting a 'requirement' or an interpretation that do not make sense to your organization!

How's that for ?!?

You need to keep reading 1.2. Let me help you:

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.

Read also this document and the one titled Guidance on ISO 9001 Sub-clause 1.2 'Application' While many CB's will allow creative fencing around scopes, the intent of the last 2 paragraphs in ISO 9001:2008 section 1.2 is quite clear. As long as registrants play games with registrars, we will see more erosion of confidence in the certification process.

 

[Stijloor]

:mg: I cannot believe what I am reading from the others posters!:mg: (OK, I am a little harsh on you guys here! My bad!)

Don't underestimate the capabilities of the posters who responded.
No need to be harsh, just professional.

Stijloor.

 

[DrM2u]

Don't underestimate the capabilities of the posters who responded.
No need to be harsh, just professional.

Stijloor.

Sorry, didn't mean to imply that I am questioning anyone's capabilities. I've been posting for a while and read many comments; no doubt that everyone is professional and capable of providing valuable input! It's me just having an off-day, feeling a little edgy. My apologies if I ofended anyone!

 

[Big Jim]

You need to keep reading 1.2. Let me help you:
Read also this document and the one titled Guidance on ISO 9001 Sub-clause 1.2 'Application' While many CB's will allow creative fencing around scopes, the intent of the last 2 paragraphs in ISO 9001:2008 section 1.2 is quite clear. As long as registrants play games with registrars, we will see more erosion of confidence in the certification process.

For the sake of discussion, suppose that an organization's scope statement says "Design, Manufacture, Distribution, and Sales of CNC Machined Parts for Aerospace and other applications". Suppose also that part of the same company and in the same facility manufacture automotive dash covers using plastic injection molding machines.

Are you saying that the scope of registration would be incorrect because it did not include a portion of business they do not want to get registered?

 

[Sidney Vianna]

Are you saying that the scope of registration would be incorrect because it did not include a portion of business they do not want to get registered?

No, the organization has to freedom to limit the scope of certification, as to fit their business needs. However, the organization must not be able to exclude processes that impact their ability to satisfy customer and legal requirements.

Obviously, the scope of certification must be truthful.

 

[DrM2u]

You need to keep reading 1.2. Let me help you:

Sidney, I am not disputing what an ORGANIZATION can exclude or list as not applicable related to the requirements of ISO 9001. That is almost clear, even some might argue otherwise and interpret it diferently.

Read also this document and the one titled Guidance on ISO 9001 Sub-clause 1.2 'Application' While many CB's will allow creative fencing around scopes, the intent of the last 2 paragraphs in ISO 9001:2008 section 1.2 is quite clear. As long as registrants play games with registrars, we will see more erosion of confidence in the certification process.

Like I said in my previous post, the key word is ORGANIZATION. Please reference ISO 9000 for the applicable definition of the term ORGANIZATION in ISO 9001 standard. A company or corporation can decide that it is made up of multiple ORGANIZATIONS and also decide what ORGANIZATIONS to register. Are you trying to say that the likes of GM, Ford, Chrysler and many other larger corporations with multiple locations and departments have only one scope and registration? They have defined plants and/or departments ar ORGANIZATIONS (each with its own scope) that they wanted to have registered. Why else would there be multiple registration schemes available?!?

As a side note: the documents referenced by you are GUIDANCE documents, not requirements or sanctioned interpretations. Am I wrong?!?

I stand by my previous statements unless someone can bring a more compeling argument.

 

[Sidney Vianna]

Like I said in my previous post, the key word is ORGANIZATION.

show me a certificate that states something like

A part of the manufacturing department of organization ABC has been found to comply with ISO 9001:2008

If you are going to limit the scope of certification to a part of a department, you should not obviously claim that ABC is certified....

Are you trying to say that the likes of GM, Ford, Chrysler and many other larger corporations with multiple locations and departments have only one scope and registration? They have defined plants and/or departments ar ORGANIZATIONS (each with its own scope) that they wanted to have registered. Why else would there be multiple registration schemes available?!?

Did you read the scenario 10 in the Guidance on ISO 9001 Sub-clause 1.2 'Application' document?

 

[Sidney Vianna]

To follow my own advice ... Please show us where in the ISO 9001 or any sanctioned interpretation is this requirement documented. I could not find it ...

I did already. It is CLEARLY stated in the last paragraph of ISO 9001:2008, section 1.2.

 

[DrM2u]

show me a certificate that states something like [...]

Sidney, the OP is talking about not including the R&D in the scope of registration, not about excluding half of their manufacturing department. Since we are splitting hairs, in the past I have audited a couple of facilities that manufacture widgets and 'top secret' components on the same manufacturing floor, under the same roof. Their scope of registration was manufacturing of widgets onyl, therefore I was not supposed to or allowed to venture into the reastricted area to audit those processes. The scope of registration and the certificate were very clear as to what was falling under the ISO 9001 umbrella.

If you are going to limit the scope of certification to a part of a department, you should not obviously claim that ABC is certified.... Did you read the scenario 10 in the Guidance on ISO 9001 Sub-clause 1.2 'Application' document?

Any decent registrar provides to their clients guidance regarding the claims of registration, among other things. I encountered a few instances where a distributor had to specify on their catalog what distribution centers were registered since they were listing all their locations and not all were registered. This is exactly in line with Scenario 10 that you are referencing. This is also why I suggested to the OP to consult with their registrar to ensure that the scope is properly defined.

I still stand by my position ...

 

[Sidney Vianna]

Sidney, the OP is talking about not including the R&D in the scope of registration, not about excluding half of their manufacturing department.

You was the one who stated

Heck, you can exclude half of your manufacturing if you choose.

Since we are splitting hairs, in the past I have audited a couple of facilities that manufacture widgets and 'top secret' components on the same manufacturing floor, under the same roof.

I don't agree that we are splitting hairs. As I said already, it is totally acceptable for an organization to limit the scope of certification. Obviously, the certificate has to be truthful to what exactly is being certified. In the OP's case, if they exclude the product development processes from the QMS and go for certification, an educated customer should ask: Why is design not covered under the certification? This organization is design responsible, after all. Irrespective if the organization considers the Design function a "supplier", even outsourced processes are responsibility of the organization.

Remember, as well, that ISO 9001 4.2.2 requires the quality manual to identify and justify exclusions and references section 1.2. ANAB accredited CB's are MANDATED to ensure that scopes of certification and quality manual exclusions are appropriately documented.

Just like in the old days of ISO 9001 and 9002, when CB's would certify design-responsible organizations to 9002, games are still being played today. And the only way to put an end to this is NOT more policing by accreditation bodies, but better educated users of management system certificates. Knowledgeable customers that would keep their suppliers and suppliers CB's accountable to the spirit of the accredited certification process.