Endnotes

[1] The subject has received some deserved dedicated attention. See, for example, Brumm, Eugenia K., "Managing Records for ISO 9000 Compliance," Quality Progress, January 1995, p. 73. The book of the same title is also available from the ASQ, ISBN 0-87389-312-3.

[2] Quality System Regulation, Part VII, Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 820, Current Good Manufacturing Practices (CGMP): Final Rule, October 7, 1996, published by the SAM Group, Stat-A-Matrix, Edison, N.J., Sec. 820.181: Device Master Record.