Subpart H - Acceptance Activities (§§ 820.80 - 820.86) Subpart I - Nonconforming Product (§ 820.90) Subpart J - Corrective and Preventive Action (§ 820.100) Subpart K - Labeling and Packaging Control (§§ 820.120 - 820.130) Subpart L - Handling, Storage, Distribution, and Installation (§§ 820.140 - 820.170). Preambles to 21 CFR Part 820. Preambles are the notes that FDA publishes when it announces a proposed or final rule. They respond to comments submitted by industry. Correspondence Between ISO and 21 CFR 820 Regulatory Compliance Associates® Inc., 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158 5 ISO US FDA Quality System Regulation (QSR - 21 CFR 820) The quality manual shall outline the structure of the documentation used in the quality management system. Table 1—Comparison of 21 CFR Part 820 to ISO 21 CFR Part 820 Quality System Regulation sections (“the Regulation”) ISO clause(s) (“the Standard”) Similarities, significant differences, and key requirements N/A 0.1 Introduction, general 0.2 Clarification of concepts 0.3 Process approach 0.4 Relationship with ISO 9001.
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