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Poor control of testing chemicals – which ISO 13485/9001 clause does it contravene?
I just started at a company that is ISO 13485/9001 certified but has only been so for 2 years. Some areas make medical devices, some do not and some work with both. We've had problems with departments conforming to the standards, especially the 9001. We have one area that performs chemical testing-I would say it's analogous to inspections testing-on both types of products. During an internal audit they were issued none conformances for the chemicals they use in testing the product not being marked with acceptance stickers, really have no specs, and are used at times when they are expired. Their argument is that because it's raw materials that are not used in production of the product then it doesn't apply. I've been asked to show where it states that in the standard. I've argued that it falls under 7.6 Control of Monitoring and Measuring Devices to no avail. Can I get some opinions on who is interpreting the standard correctly?
Thanks in advance!
I just started at a company that is ISO 13485/9001 certified but has only been so for 2 years. Some areas make medical devices, some do not and some work with both. We've had problems with departments conforming to the standards, especially the 9001. We have one area that performs chemical testing-I would say it's analogous to inspections testing-on both types of products. During an internal audit they were issued none conformances for the chemicals they use in testing the product not being marked with acceptance stickers, really have no specs, and are used at times when they are expired. Their argument is that because it's raw materials that are not used in production of the product then it doesn't apply. I've been asked to show where it states that in the standard. I've argued that it falls under 7.6 Control of Monitoring and Measuring Devices to no avail. Can I get some opinions on who is interpreting the standard correctly?
Thanks in advance!
