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820.50b Purchasing
data. Each manufacturer shall establish and maintain data that clearly
describe or reference the specified requirements, including quality
requirements, for purchased or otherwise received product and services.
Purchasing documents shall include, where possible, an agreement that the
suppliers, contractors, and consultants agree to notify the manufacturer of
changes in the product or service so that manufacturers may determine whether
the changes may affect the quality of a finished device. Purchasing data
shall be approved in accordance with § 820.40. Interpretation:
Suppliers
are evaluated prior to their services.
Critical changes in the supplier’s process (and or supplies) may lead
to a change in product safety or efficacy without your company’s
knowledge. You must have
something in writing that states a supplier will contact you prior to making
these changes. It is also important to include (as part of notification) a
clause that states “major changes to quality system”. This includes the actual quality
program but may include changes to key personnel in the quality role. |
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Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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