Design Exclusion for AS9100B and not ISO 9001 - 7.3 Design conflicts

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?

Thanks in advance!

Re: AS9100B - 7.3 Design conflicts

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.

JDSands said:

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.

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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.

JDSands said:

Or will all designs have to follow the AS requirements?

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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.

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...

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.

JDS

JDSands said:

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...

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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

kiwisfly said:

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.

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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.