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Adding AS9100 after implementing ISO 9001 and ISO 13485

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Guest user Created:   Oct 08, 2019 Last commented:   Oct 09, 2019

Adding AS9100 after implementing ISO 9001 and ISO 13485

Hi, We currently have ISO 9001 and ISO 13485 certification with BSI at our manufacturing facility. We are thinking of adding AS 9100. We are willing to update our 9001 scope so it is the same as AS 9100. But is it correct in thinking if we have AS 9100 then we have 9001? Also we currently have one QMS to cover both ISO, would we need a separate QMS for AS 9100? I feel like supplier evaluation and traceability are pretty similar requirements of AS 9100 and ISO 13485. Thank you for your help!
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AS9100 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

AS9100 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Mark Hammar Oct 09, 2019

The AS9100 Rev D standard includes all of the ISO 9001:2015 requirements with the addition of specific aerospace requirements (and nothing taken away); so, the answer is yes, if you have AS9100 you also have ISO 9001 (and many of the certifications include both standards printed on the certification. You do not need to have a separate QMS for the AS9100, and can integrate these additional requirements into your existing QMS for ISO 9001 and ISO 13485. You are correct, some of the requirements are similar between the two standards as aerospace and medical devices are both highly regulated and might have similar legal restrictions.

If you want a better understanding of the AS9100 Rev D requirements to compare to your QMS, see the whitepaper: Clause-by-clause explanation of AS9100 Rev D, https://info.advisera.com/9100academy/free-download/clause-by-clause-explanation-of-as9100-rev-d

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