1. 21 CFR Part 210, 2005. Available at (accessed 26.09.06).
2. 21CFR Part 211, 2005.Available at (accessed 26.09.06).
3. Bartholomew, D., 2006. CAPA and root cause analysis, Available at (accessed 9.08.06).
4. Center for Devices and Radiological Health “CDRH,” 2000. Guidance for industry and FDA premarket and design control reviewers medical device use-safety: incorporating human factors engineering into risk management division of device, U.S. Department of Health and Human Services Food and Drug Administration User Programs and Systems Analysis Office of Health and Industry Programs.
5. The art of TQM;Corrigan;Quality Progress,1995