AS9100 - 8.5.1 production and service provision
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In AS9100, throughout the standard, all requirements are applied to the products AND services of the company. So, throughout the operations requirements in clause 8 the intent is that these will apply to both products and services of the company. As you have indicated, you do not exclude design and development as you take part in it, and apart from some minor differences in meaning as to this being a service or not it is actually a bit irrelevant. If you have identified the requirements for this activity, including those needed to meet the needs of your customers, and these are part of your process then if you have a scope of “design and manufacturing” or “design services and manufacturing” the end outcome is really irrelevant.
Even if this activity is considered a service, I am sure that you have all the applicable “controlled conditions” of your service provision included to meet your needs, remembering that the clause 8.5.1 requirements are deemed “as applicable” to whichever product or service they are applied. In the end you have a process that meets the needs of you and your customer.
This change for products and services, along with the ability to exclude design and development from the QMS, is explained a bit more in this article: Can companies still exclude design and development from their AS9100 Rev D QMS?, https://advisera.com/9100academy/blog/2017/10/09/can-companies-still-exclude-design-and-development-from-their-as9100-rev-d-qms/
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Jun 11, 2021