If I make design change on a module that was already qualifed by an independent accredited laboratory, should I have to repeat the entire qualification test program?
Probably not. To reduce the time and cost for manufacturers on their design improvement, and to ensure the high integrity of the qualification program, a special document called “Guidelines for retest requirement” has been developed. Under this guideline, based on the nature of the changes, some require only a few retests, and some may require more retests. The number of tests will be determined based on the “Similarity Declaration Form” submitted by the manufacturer.
Related Questions
- If I make design change on a module that was already qualifed by an independent accredited laboratory, should I have to repeat the entire qualification test program?
- When a hospital is accredited or approved, but is part of a larger organization system, can they offer programs for the entire system under their name?
- How long does the entire process take from design to installation?
