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We are a specification developer that designs a product used to take measurements of certain health statistics, (blood pressure, pulse, weight, etc.), with placement primarily in retail locations. Other than Design Control, Risk Management, & some R&D for future development, we have outsourced most other key manufacturing processes, including manufacturing, service, packaging and shipping, purchasing, complaint handling, etc., so we consider ourselves more of a virtual manufacturer. During a recent ISO 13485 surveillance audit, we received a minor non-conformance for not having our calibration lab and Pest Control service on our approved supplier's list. I can understand the Calibration Lab since we do use inspection and measurement equipment to determine product specifications and need to have a reliable lab with traceable standards, but am slightly puzzled on the observation for Pest control
If our finished product is not manufactured, assembled, or stored at our facility, and we don't maintain component inventory used for the product's manufacture, why would we have to qualify a Pest Control service? I would appreciate anyone's thoughts on this matter
If our finished product is not manufactured, assembled, or stored at our facility, and we don't maintain component inventory used for the product's manufacture, why would we have to qualify a Pest Control service? I would appreciate anyone's thoughts on this matter
