ISO 9001 Requirements for Raw Material Supplier Assessment and Approval

#1
I'm new to ISO 9001, but come from an ISO 13485 background. Adjusting to the gray areas in this standard has been a bit challenging. My new company allows the purchaser to assess and approve raw material suppliers with no review or approval from higher up. Is that considered acceptable?

Thanks for any input you can offer.
 
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Sidney Vianna

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#2
Welcome to The Cove, Kelley. Without more context is really hard to provide meaningful feedback. Under the risk based thinking framework one should implement ISO 9001, the last paragraph of section 8.4.1 requires your organization to establish and enforce criteria for the selection of suppliers. Depending on the nature of the raw material, a simple selection process could be ok. In other cases, if risk of supply disruption can create huge problems for your organization, RBT 101 would suggest you might benefit from a multi-disciplinary, intensive supplier selection and approval process, with layers of reviews, including higher ups.

There is no one-size fits all. Context and risks have to be assessed to determine the adequacy of any supplier approval process,
 

qualprod

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#3
I'm new to ISO 9001, but come from an ISO 13485 background. Adjusting to the gray areas in this standard has been a bit challenging. My new company allows the purchaser to assess and approve raw material suppliers with no review or approval from higher up. Is that considered acceptable?

Thanks for any input you can offer.
If he or she has sufficient authority And competence, Is ok, the standards doesnt specify who, Is up the organization to define it.
 

tony s

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#4
My new company allows the purchaser to assess and approve raw material suppliers with no review or approval from higher up.
Maybe your company did apply this:
5.3 Organizational roles, responsibilities and authorities
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.
Top management shall assign the responsibility and authority for:
b) ensuring that the processes are delivering their intended outputs.
 
#7
I'm working with a company(Medical Devices) do the design, they are not a manufacturer, we give the manufacturing process to another company,
My question is when we receive the finished products in our warehouse do I need to establish a sampling plan for inspection or not?
 
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