Endnotes

[1] See, for example, Advanced Product Quality Planning (APQP), Reference Manual, from AIAG, June 1994, tel: [phone].

[2] ISO 10005:1995(E) presents several typical quality plan configurations that include plans for service organizations, manufactured product, processed material, and a software life cycle.

[3] 21 CFR Part 820 Quality System Regulation, FDA/CGMP Sec. 820.181, October 7, 1996.