Temperature mapping of storage areas ISO13485

Yes, you are right when you say that temperature mapping is not mandatory or required in ISO 13485. However, what is required in point 7.5.11 is that the manufacturer must protect the product from alteration, contamination, or damage when exposed to expected conditions during processing, storage, handling, and distribution. If your warehouse is racked and tall or divided (to have more rooms), then temperature mapping is needed to make sure that the temperature distribution is equal, that is, that the products, regardless of where they are located within the warehouse, are stored at the same temperature.

If this is not the case, and your storage is in one room, of normal height, and you can prove that the temperature distribution is equal, then you can justify that temperature mapping is not necessary.

Yes, you are right when you say that temperature mapping is not mandatory or required in ISO 13485. However, what is required in point 7.5.11 is that the manufacturer must protect the product from alteration, contamination, or damage when exposed to expected conditions during processing, storage, handling, and distribution. If your warehouse is racked and tall or divided (to have more rooms), then temperature mapping is needed to make sure that the temperature distribution is equal, that is, that the products, regardless of where they are located within the warehouse, are stored at the same temperature.

If this is not the case, and your storage is in one room, of normal height, and you can prove that the temperature distribution is equal, then you can justify that temperature mapping is not necessary.