Hi everyone. :)

I wasn't sure if this was the right thread to add to for my first posting but I have run into a problem with Design exclusion for AS and not ISO 9001.

We currently have 9001:2000 and have NO exclusions as there are design and development activities in a division of the business. However, we are looking at implementing AS9100 for which we do NOT perform any design activities.

How can I separate this in our scope of the AS9100B to exclude design for aerospace but include it in the other areas of the business. Or will all designs have to follow the AS requirements? :confused:

Thanks in advance! :agree1:

Hi JD,
You should contact your current registrar and discuss this with them, as it may be possible, based upon a specifically carved out scope statement for the AS9100, to be able to do what you are asking. But, it would require you to provide much more detailed information, on who, what and where, etc. for your registrar to be able to determine if this would be possible for your system, or not.

How can I separate this in our scope of the AS9100B to exclude design for aerospace but include it in the other areas of the business.You can have different scopes of certification for different standards. Since you are not involved with design of aerospace products, your registrar can:

issue you a single certificate with two separate scopes of certification, or
you can have two separate certificates: one for ISO 9001 including design and the second for AS9100 excluding the design processes.Or will all designs have to follow the AS requirements?No. That would not make sense. Your product design processes only have to satisfy the ISO 9001 requirements.

I agree with every point of Sidney's post. As usual, he's got it covered. :agree1:

I have a client who had the same issue. Within the quality manual we clearly stated the 2 scopes; one for ISO 9001:2000 and the other for AS9100.

Thanks to you all for your advice and help.
The situation has deepened somewhat after speaking with our registrar. The reply I got was:
"The Scope does not adequately define the activities performed by the organization that are to be certified to the AS9100 Rev B standard. In addition, the current Scope includes activities for Design, which are then excluded from the QMS for AS9100 Rev B, but not excluded from ISO 9001:2000. This is not permissible. Scope can not contain reference to any activity where an exclusion is being claimed for such activity. In addition, please refer to section 1 SCOPE of the AS9100 Rev B standard, which states that “This standard includes ISO 9001:2000 QMS requirements….”

We cannot have 2 scopes and we cannot exclude design... :bonk:

Just to clarify, we have one QMS "combined manual" that covers all the AS and ISO 9001 requirements. The manual has passed many audits without the AS requirements added. We have 4 product / service types (treated as different businesses as the technology is so different) within the site scope. 1 of these product types provides a service to the aerospace industry. The others are completely independent of this area although all are covered under the ISO 9001 system.

We would like to have the 1 business area qualified to AS9100 and exclude the other areas. I offered a scope with very specific verbage to the auditor to cover this and even 2 scopes as suggested but they are standing firm...

Our ultimate goal here is to get NADCAP certification and AS certification is one way. Has anyone gone the AC7109 or AC7001 route rather than the AS > NADCAP or can offer other advice on how we should proceed?

Again, thanks in advance for all your help and assistance. :D :thanks: :D

JDS

Thanks to you all for your advice and help.
The situation has deepened somewhat after speaking with our registrar. The reply I got was:
"The Scope does not adequately define the activities performed by the organization that are to be certified to the AS9100 Rev B standard. In addition, the current Scope includes activities for Design, which are then excluded from the QMS for AS9100 Rev B, but not excluded from ISO 9001:2000. This is not permissible. Scope can not contain reference to any activity where an exclusion is being claimed for such activity. In addition, please refer to section 1 SCOPE of the AS9100 Rev B standard, which states that “This standard includes ISO 9001:2000 QMS requirements….”

We cannot have 2 scopes and we cannot exclude design... Yes, you can. Your registrar is mistaken. The question now is: What are YOU going to do about it? Are you going to roll over or argue your point? The answer that you cut and pasted resembles auditor-ese. Are you talking to someone at a Technical Review level at the registrar?

Normally, the threat of taking your business elsewhere is followed with "understanding" and "flexibility" by the CB. I find amazing how some CB's keep on having an adversarial relationship with their customers. And, most of the time, not for noble reasons. This case clearly exemplifies it. CB's are not accostumed to being challenged. This case, however, is a slam dunk....shish where did I hear that before?

Maybe you want to speak to other registrars that you will not have to fight with. Also, each registrar has an appeals process and you can ask to have your case go through the process.

The scope defines the applicability of the standard to the system. If you limit your scope clearly for AS9100, there should be no issues.

Most of my clients have received AS9100 certifications from registrars other than PRI and then they went for the NADCAP.

Hi JD Sands
The advice from Sydney and DannyK is absolutely correct, the response from your registrar is wrong but I think I know why. The Aerospace Quality Management System rules for certification allow a Registrar / Certification Body to issue both AS9100 and ISO 9001 certificates from a single AS9100 audit, but for this to occur, the scope of the AS9100 and ISO 9001 approvals must be the same. Hence, I can see why your registrar has taken a narrow view of your query.

I recently completed an audit where the company was in exactly the same situation as you. They have just the single AS9100 audit and have received both AS9100 and ISO 9001 certificates with the same scope. Design is excluded during these audits as the company do not design aerospace components.

I also spend extra time (outide of the official AS9100 audit period) auditing their design department to ISO 9001 Clause 7.3 and the registrar I work for issues a separate ISO 9001 certificate to a scope that does include design. The reports reviewed to show evidence of conformity to this wider scope is the AS9101 and the additional audit report relating to the design department.

The company now has two ISO 9001 certificates but only one is used as they use the AS9100 certificate to demonstrate their capability to aerospace customers and wider scope ISO 9001 certificate for other customers.

I hope this helps,

Cheers:bigwave:

The advice from Sydney and DannyK is absolutely correct, the response from your registrar is wrong but I think I know why. The Aerospace Quality Management System rules for certification allow a Registrar / Certification Body to issue both AS9100 and ISO 9001 certificates from a single AS9100 audit, but for this to occur, the scope of the AS9100 and ISO 9001 approvals must be the same. Hence, I can see why your registrar has taken a narrow view of your query. We maintain ISO9001:2000 and AS9100B registration - two certs with different scopes - and we have single audits. The auditor simply doesn't apply the AS9100 requirements to non-aerospace work.

Our scopes are different in that we do not repair aerospace product. Our company repairs ballscrews - but not aerospace articles. Our aerospace work is strickly new manufacture right now.

Cari,
Thanks to you and to Kiwisfly!

Does anyone else have examples of two scopes for AS9100 & ISO 9001? Especially with Design exclusion.

Our registrar has told us we can go with 2 scopes 1 for AS and one for ISO, just as everyone is telling and showing me here, but we have to be very specific (down to part numbers) in our scope. I said that this will limit us for new work and change our scope as soon as a new part comes along or is changed.

Thanks in advance guys :)

I also spend extra time (outide of the official AS9100 audit period) auditing their design department to ISO 9001 Clause 7.3 and the registrar I work for issues a separate ISO 9001 certificate to a scope that does include design. The reports reviewed to show evidence of conformity to this wider scope is the AS9101 and the additional audit report relating to the design department.

The company now has two ISO 9001 certificates but only one is used as they use the AS9100 certificate to demonstrate their capability to aerospace customers and wider scope ISO 9001 certificate for other customers.

Hi Kiwisfly, - Thanks for your help and input! :D
Can I assume that this "extra work" was also an additional charge and the time spent in total was the same as two separate audits, one for AS and one for ISO 9001? Or was this outside of the ISO19011: 2002 requirements? How does that work to be compliant? :read:

Cheers ! :agree1:

Hi JD,
You should contact your current registrar and discuss this with them, as it may be possible, based upon a specifically carved out scope statement for the AS9100, to be able to do what you are asking. But, it would require you to provide much more detailed information, on who, what and where, etc. for your registrar to be able to determine if this would be possible for your system, or not.

Can anyone give an example of the type of scope that RegistrarGirl mentions? :read:

I am sure that we are not the only company in this situation with design conflicts in AS and ISO. (None in AS but plenty in ISO).
Thanks in advance!
JDS :D

Our registrar has told us we can go with 2 scopes 1 for AS and one for ISO, just as everyone is telling and showing me here, but we have to be very specific (down to part numbers) in our scope. Hi, JD :bigwave:
I've never been told that and we do not have part numbers in our scope. Our work is identified on the routers as being military or aerospace. We even have some customers that we make both commercial/industrial stuff and aerospace stuff for. Their contracts state what the application is and they specify different levels of control based on the end user's application.

Perhaps if you spoke to some other registrars on the subject. And I'd like to revisit Sydney's question about who - at your registrar - is giving you this information. Is it an account manager / sales rep - or are you speaking with a technical manager?

A note in paragraph 8.6 of AS9104 states:

If necessary, separate certificates, one for ISO 9001 and another for the AQMS standard, could be issued.

Thanks to all for your help.
We now have a plan going forward. Our registrar has agreed to issue two certificates, one for ISO 9001 and the other for AS9100. Phew. :D

:thanks: Thanks to all for your input. :thanks:

Now I am off to get our FOD program up and running and don't forget that shelf-life program... :biglaugh:

More questions to come I am sure. As always, the Cove comes through!

Cheers guys and gals {_}] (Beer glass)

Hi Kiwisfly, - Thanks for your help and input! :D
Can I assume that this "extra work" was also an additional charge and the time spent in total was the same as two separate audits, one for AS and one for ISO 9001? Or was this outside of the ISO19011: 2002 requirements? How does that work to be compliant? :read:

Cheers ! :agree1:

Hi JD Sands
Sorry about the delay in responding, been a bit busy to browse lately, I hope my response is still of interest. Yes, the extra work is additional (time and charge) to the AS9100 visit but the time was very short compared to the AS9100 audit as there was just the design clause (and related controls) to test and assess. The audit was in accordance with ISO19011.

Just a note about the certificates Cari posted. You will notice that there is no reference to the words "design" or "manufacture" in the scope of Cari's certificates so the AS9100 / ISO 9001 issue regarding the design clause is avoided. You can't actually tell from the scope of either certificate if design is included or not. I'm not sure if this was deliberate but it is important that the AS9100 certificates accurately reflect the scope of the registration.

We in the certification business must take care that we do not lose the confidence of those promoting the AQMS standards (regulators and OEM's) as there is no scheme without them. I always use the words design and/or manufacture as it provides the customers with a clear indication of what I have audited and what the registration covers.

I would be interested in what others think about this???

P.S. Cari, please don't consider this any kind of criticism of your system or registration. I thank you for posting it for JD's reference, I'm sure it helped the discussions with the registrar.

Cheers
:bigwave: