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ISO 9001:2008 Purchasing Process

  • 7.4.1 Purchasing Process – You need to ensure your requirements are clear and properly communicated to the provider so you receive the correct material/service. How do you select your suppliers?
    • You should choose a “scope” for this requirement to decide which materials/services are controlled by your QMS – because it does not make sense to try to control all of them. Does your pencil supplier need to be controlled? A general rule of thumb of is: can their performance impact your ability to meet your customers’ requirements.
    • Thus – develop an approved supplier list for critical materials/services, and a process for approving them.
    • KEY ITEM: Make sure employees (receiving, purchasing, etc.) have the most recent (controlled) list.
  • 7.4.2 Purchasing Information – How do you ensure you ordered the right material/service from your supplier? Your organization needs to verify the requirements before ordering.
    • Does it require approvals? (UL listing, etc.)
    • Do the supplier’s employees need credentials? (PE – a Professional Engineer, Registered Architect, etc.)
    • QMS Registration – do they need to be ISO 9001/14001/13485 certified?
    • KEY ITEM: make sure your requests are accurate
  • 7.4.3 Verification of Purchased Product – How do you ensure their product/service met your requirements? Part of the purchase process is to verify that the goods/services that you procured. Typically this is performed at incoming inspection, but you could put the verification process on the supplier and provide validation of this (such as a certificate of conformance or COC).
    • Create a receiving process or work instruction –
    • KEY ITEM: this applies to both products and services.

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