Hello All,
Need some help. The 2016 version of ISO 13485 has two requirements that seem nearly the same, at least from my experience. It says Supplier Selection and Evaluation criteria shall be (skipping a and b): c) based on the effect of the of the purchased product on the quality of the medical device, d) proportionate to the risk of the medical device.
Effect on quality of the device and proportionate to the risk of the device seem joined at the hip to me. Things that affect quality also affects risk of the device. Any idea what the intent of this requirement was? Interested in your experience and opinions regarding this. Thanks!
Need some help. The 2016 version of ISO 13485 has two requirements that seem nearly the same, at least from my experience. It says Supplier Selection and Evaluation criteria shall be (skipping a and b): c) based on the effect of the of the purchased product on the quality of the medical device, d) proportionate to the risk of the medical device.
Effect on quality of the device and proportionate to the risk of the device seem joined at the hip to me. Things that affect quality also affects risk of the device. Any idea what the intent of this requirement was? Interested in your experience and opinions regarding this. Thanks!