Production and Service Provision - AS9100 vs. ISO 13485 - Numbering Issues

D

dmlee

#1
My company is currently ISO 9001:2000/AS9100 certified and we're looking into getting ISO 13485 certification as well. I haven't had any trouble incorporating them together except for 7.5. The reason being the numbering doesn't match up. How is this usually gone about? ie: 7.5.1.1 is "General Requirements" for ISO 13485 and "Production Documentation" for AS9100.

Thanks in advance.

Dan
 
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#2
My company is currently ISO 9001:2000/AS9100 certified and we're looking into getting ISO 13485 certification as well. I haven't had any trouble incorporating them together except for 7.5. The reason being the numbering doesn't match up. How is this usually gone about? ie: 7.5.1.1 is "General Requirements" for ISO 13485 and "Production Documentation" for AS9100.

Thanks in advance.

Dan
The numbering doesn't matter, it just makes it easier for the auditor. If you want, make a cross reference list between the standards and your manual similar to this one.
 
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