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Design and development requirement

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Guest user Created:   Dec 06, 2019 Last commented:   Dec 09, 2019

Design and development requirement

I have a concern with respect to Design and development.
Our company is preparing for ISO 9001 standard and this question is with regards to D & D. My question is as follow:
We have an outsourced agency who does the D & Dfor us, so in this case, is the design requirement applicable to us?

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Carlos Pereira da Cruz Dec 06, 2019

You say that you outsourced the D&D. If you outsource, you control, you own D&D. So, the design requirement is applicable to you: You have an order where you specify what you want, or need, you have some kind of interim project control. And you have some kind of verification activities, where you compare a prototype with the input requirements, the order. 

You may not have control or information about how they develop the project, but you have a plan, and you have control points

The following material will provide you information about scope and applicability:

- ISO 9001 - What clauses can be excluded in ISO 9001:2015? - https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/
ISO 9001 - How to control outsourced processes using ISO 9001: https://advisera.com/9001academy/blog/2015/05/05/how-to-control-outsourced-processes-using-iso-9001/
. free webinar on demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/
- free online training ISO 9001:2015 Foundations Course – https://training.advisera.com/course/iso-9001-foundations-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

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Guest user Dec 06, 2019

Thank you for the prompt response.

The outsourced agency also performs the design and producing prototypes. In addition, they also perform the verification and validation activities.

Even then, will 8.3 is applicable to us?

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Carlos Pereira da Cruz Dec 09, 2019

The outsourced agency also performs the design and producing prototypes. In addition, they also perform the verification and validation activities.Even then, will 8.3 is applicable to us?

OK, the most critical issue is, who decides the what the product will be? Some companies go to a fair or an exhibition and see final products in a “shelf” and they buy the right to manufacture that product. In this case clause 8.3 is not applicable but you have to define the points below. Some companies order the development of a product, even if the order is with turnkey delivery clause 8.3 is applicable. In your case, if your organization is of the second case, clause 8.3 is applicable as a special case of clause 8.4:

- Define a specification for the product
- I do not know if you monitor the D&D
- Define your approval of a final version
- Define how your organization receives the required information about specifications for clients, specifications for buying materials, development of manufacturing process, development of quality control plan, development of packaging, …

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Dec 09, 2019

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