Q
What are the requirements, per ISO 9000, for the validation of new processing equipment? If you replace a piece of equipment with something equal to or better than the old one, is it enough to document that:
A. The equipment is properly installed per the manufacturer's instructions
B. That the guages and controllers are set to the recommended settings
C. That test material has been ran through the process and that the end
results are within stated parameters
Is there more that we are required to do per ISO?
A. The equipment is properly installed per the manufacturer's instructions
B. That the guages and controllers are set to the recommended settings
C. That test material has been ran through the process and that the end
results are within stated parameters
Is there more that we are required to do per ISO?