Surgical Instrument Supplier – Certification?

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    My company manufactures surgical instruments.  A few products we sell are those purchased from another supplier.  Often times these purchased products are used in conjunction with our own instruments.
    We’re accustomed to receiving, at the very least, a certificate of conformance statement from suppliers, if not a material certification or analysis. 
    One recent supplier claims the manufacturer of the product they are supplying us will not release any information.  We don’t know if the product truly is what they say it is; though it “looks” right!
    Are there any regulations for supply stores to release product manufacturer info?  I’ve perused the web and found that some supply stores provide manufacturer brochures or simply the name of the manufacturer for purchasers to reference.



    A caveat to begin.  I worked in the electronics industry for many years, not the health industry.   I don’t know if regulations exist, or not, however, your company should have guidelines to address dealing with sub-contractors or suppliers, and I suggest you start with those.   In my industry, we would not deal with suppliers who would not enter into a relationship with us that required supplier audits, and/or data with incoming shipments.   Typically, once a supplier was evaluated and approved, the amount of data requested of them would be determined and then reviewed based upon their performance.   Good performance over many shipments would result in the potential for less data required with future shipments. 
    In your instance, the data should meet the quality standards that you expect of your own manufactured products, no less.  You should define those characteristics that are truly important and ask for this data to evaluate the supplier, including reviews of their data and production methods.  This should lead to a decision on whether to accept product or not from this supplier.

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