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ISO 9001 Design and Development exemption

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Guest user Created:   Jan 07, 2020 Last commented:   Jun 30, 2020

ISO 9001 Design and Development exemption

My company is currently exempt from Section 8.3 for Design and Development because we don't do design here. Our design is done at our facility who is under their own ISO Certification and we are just an in between. 

We are considering the addition of an engineer that would do design but would be completely controlled by our facility's processes, practices, and systems. They would just be seated at our facility as convenience to our customers and not under our systems and processes. Does our facility need to comply to Section 8.3 even though we still don't technically have design under our control?

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Carlos Pereira da Cruz Jan 07, 2020

According to your description my answer is no.

The applicability of clause 8.3 is a function of the scope of your organization’s quality management system (QMS). If design and development activities are not included in your QMS scope, it is not applicable.

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

- 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/
– How to define the scope of the QMS according to ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
- 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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Marco Jun 29, 2020

So for a company that provides consulting services, this clause can be excluded as the company only provides services by request of the customer. The company will not approve or modify any product, design or manufacturing process without the approval of the customer. 

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Expert
Carlos Pereira da Cruz Jun 30, 2020

No, for a company that provides consulting services, this clause cannot be excluded. For example, your organization provides ISO 9001 consulting services, and next year can start to provide ISO 14001 consulting services. The customer does not decide what kind of services your organization provides. The customer does not decide your technique or approach to the service. The customer just provides information in order to customize the service to its particular needs and requirements.

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Marco Jun 30, 2020

We provide engineering consulting services but want to have the ISO 9001 certfication.

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Marco Jun 30, 2020

Thanks for the reply.

Let me clarify, the company provides engineering consulting services but want to have the ISO 9001 certfication. Engineering needs for the customers, such as project management, validations, quality systems, risk assessment. Everything is owned by the customer; the company is hired to assign a person for a project/job, get it done but in the end, everything has to be approved by the customer. 

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Carlos Pereira da Cruz Jun 30, 2020

Let us consider the possibility of a customer requesting your organization an expert to provide the service X. What the customer expects from your organization is the selection of competent people able to work with them. So, perhaps the service that requires certification is not what the person does for the customer, but the service of identifying the customer's needs and hiring/assigning the right person for the project. 
I find it odd that a company providing engineering consulting services considers clause 8.3 not applicable. If I were in your position and with doubts I would contact one or two certification bodies and ask their opinion. Remember, after all, they are your suppliers, and they want to win a customer. So, they have all the motivation to answer you.

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Jan 07, 2020

Jun 30, 2020