Using a AS9100 QMS for a New ISO9001:2008 Location

[thermistor]

Hello everyone, I searched for my answer through the two forums but did not find anything. Here are the details...

My company has been registered to AS9100 for 15 years, we recently acquired a competitor and are retaining the plant in another state. We want to bring them up to ISO9001 since all that they manufacture is material that is to be used in our assembly and there are no design functions carried out there anymore. They are to be only fab from here on out.

My question is, is it possible to use our current QM which all processes carried out will meet, for the ISO90001 system? What changes will I need to make since we do not reference the standard anywhere (Only AS9100)?

Thanks

 

[Big Jim]

Hello everyone, I searched for my answer through the two forums but did not find anything. Here are the details...

My company has been registered to AS9100 for 15 years, we recently acquired a competitor and are retaining the plant in another state. We want to bring them up to ISO9001 since all that they manufacture is material that is to be used in our assembly and there are no design functions carried out there anymore. They are to be only fab from here on out.

My question is, is it possible to use our current QM which all processes carried out will meet, for the ISO90001 system? What changes will I need to make since we do not reference the standard anywhere (Only AS9100)?

Thanks

It isn't clear from your question as to if you mean to cover both locations under one registration or two registrations. The 1st response below is assuming you want to register both sites under one registration.

It may be possible, but without seeing the manual or visiting the sites that would be difficult to answer with certainty.

Most likely you can alter the manual to accommodate both sites. How you handle the scope of registration could at least in theory accommodate AS9100 at HQ and ISO 9001 at the remote site. Questions about scope should be discussed with your certification body.

A quality manual only needs three things: 1) scope statement with justification of any exclusions, 2) include or reference your written procedures, 3) a description of the interaction of your processes.

If you want to try to use the manual from the AS9100 site for a separate registration of the 2nd site, again, it depends at least partially on how the existing manual is structured. Your documentation (quality manual and written procedures) should have any of the AS enhancements that you don't intend to live by removed. If you get a copy of AS9100C you will find all of the aerospace enhancements in bolded and italicized print.

It may be easier to start over rather than try to remove the AS enhancements.

Good luck with whatever you decide to do.

 

[John Broomfield]

Hello everyone, I searched for my answer through the two forums but did not find anything. Here are the details...

My company has been registered to AS9100 for 15 years, we recently acquired a competitor and are retaining the plant in another state. We want to bring them up to ISO9001 since all that they manufacture is material that is to be used in our assembly and there are no design functions carried out there anymore. They are to be only fab from here on out.

My question is, is it possible to use our current QM which all processes carried out will meet, for the ISO90001 system? What changes will I need to make since we do not reference the standard anywhere (Only AS9100)?

Thanks

Thermistor,

If you place no value on the processes you have bought then impose your management system on the acquired organization.

It may be better to retain the value of what you have bought. You could do this by analyzing and understanding the value adding processes of your acquisition. You can then bring these unique processes into your process-based management system.

You'll probably be sharing the support processes such as purchasing, recruiting, training, auditing, analyzing data and preventing nonconformity and stopping recurrence of nonconformity.

John

 

[Valeri]

Thermistor - attached is a file I have developed over the years. It shows differences between various standards, ISO9001, TS16949, ISO13485, AS9100, 21CFR820. This may help in your decision. Please note; the legend is at the bottom of the spreadsheet.

 

[prathiba]

Hello Thermistor,

The process which involve in the current version of AS9100 aligns the standard with ISO 9001:2008 and has extra requirements regarding Regulatory Compliance and the following implement AS9100:

• Identify the requirements of AS9100 and how they apply to the business involved.
• Establish quality objectives and how they fit in to the operation of the business.
• Produce a documented quality policy indicating how these requirements are satisfied.
• Communicate them throughout the organisation.
• Evaluate the quality policy, its stated objectives and then prioritise requirements to ensure they are met.
• Identify the boundaries of the management system and produce documented procedures as required.
• Ensure these procedures are suitable and adhered to.
• Once developed, undertake internal audits to ensure the system carries on working.

As a result, ISO 9001:2008 is totally encompassed within AS9100 with these additional requirements applied specifically addressing aviation safety concerns.