Resources

Four places to go deeper than this lesson, or to check a citation yourself before it goes in a real Lakeshore document. All four were checked and loading at the time this page was written.

• 21 CFR 820.1, Cornell Legal Information Institute — the scope section of the QMSR (Quality Management System Regulation), including 820.1(a)(3), the paragraph that excludes manufacturers of blood and blood components from Part 820 entirely. Read it in full to see the exclusion sitting next to the parallel exclusion for components and parts, and the separate inclusion for HCT/Ps (human cells, tissues, and cellular and tissue-based products) — three different carve-outs, easy to blur together if you only remember one.

• 21 CFR 820.10, Cornell Legal Information Institute — the quality-system requirements this lesson quotes from: the top-line “document a QMS complying with ISO 13485” requirement, the Class II/III design-and-development requirement, and the Part 803/806 complaint and advisory-notice cross-references. Use it to check any ISO 13485 clause-number citation against the actual CFR text before you repeat it anywhere.

• 21 CFR 864.9165, eCFR — the regulation defining BECS (Blood Establishment Computer Software) and its five special controls, including the labeling requirements for unresolved anomalies, revision history, and the traceability matrix this lesson treats as vendor deliverables. Module 3 linked Cornell’s mirror for this same section; eCFR’s version is the government’s own current, authoritative copy, worth bookmarking alongside it.

• Federal Register: Medical Devices; Quality System Regulation Amendments — the final rule that renamed and restructured Part 820 into the QMSR, published February 2, 2024, effective February 2, 2026 (document 2024-01709). Use this page to confirm the rule’s exact title, publication date, and effective date yourself, rather than taking this lesson’s word for them — and to see the rule’s own preamble if you ever need more context than a bare citation gives you.