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Edition 2026-11 · Markdown files · Notion, Obsidian, Git, AI assistants

QMSR Knowledge Pack: the QMSR, FDA inspections and electronic records, as files your team and your tools can read.

A dated reference pack on 21 CFR Part 820 as it reads now, FDA Compliance Program 7382.850, Part 11 and Annex 11, and the regulatory map for twelve jurisdictions: 65 pages of plain Markdown with front matter, citations that follow the regulation, and no copyrighted standard text.

Written by Neelank Tiwari, MS, PMP, DEKRA ISO 13485 Lead Auditor, ASQ CMQ-OE, CQA, CMDA, CSQP, CQIA.

Download the free sample USD 129 per person, one edition

The sample is six pages from the pack with the same licence terms; 4 of them can be read here. Checkout is by card; the files are delivered on the confirmation page and by email. See Buying for the licence and refund terms.

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What you get

65Markdown pages across nine sections, each with type, source, edition and licence in front matter
29crosswalk rows from the former QSR sections to the ISO 13485 clause each now arrives through
70self-assessment questions by FDA QMS area, with the record that answers each and a CSV for a database
8tabletop inspection scenarios plus a 72-question bank and a mock-inspection runbook
12jurisdiction pages with regulator, QMS basis, market-access route and official links
71glossary terms and acronyms; 15 dated milestones; a 24-item Part 11 / Annex 11 checklist
SectionRead it forPages
01 QMSRThe regulation itself: what it says, what it kept, how the former sections map to ISO 13485 clauses, dates and the transition checklist7
02 FDA inspectionsHow FDA inspects under Compliance Program 7382.850 and how to prepare9
03 Electronic records21 CFR Part 11 and EU GMP Annex 11, audit trails, computerised-system validation7
04 Regulatory mapTwelve jurisdictions, international bodies and the cited instruments with official links15
05 Warning lettersHow to read an FDA device warning letter and where the public enforcement data lives1
06 Self-assessmentEvidence questions by FDA QMS area with a scoring scale, plus a CSV for a database8
07 Audit simulationTabletop inspection scenarios, a question bank and a mock-inspection runbook10
08 GenAI in GxPValidation considerations and an evidence checklist for generative AI used in regulated work2
09 GlossaryTerms and acronyms with citations that follow the QMSR1

Who it is for

Quality and regulatory leads

Preparing a QMS for the regulation as it reads since 2 February 2026 and for an FDA inspection under the new compliance program. The transition checklist, the readiness checklist and the self-assessment are built to be ticked against records, not opinions.

Consultants

Who need a current, citable reference to use during client engagements, with every public source listed and dated and every former-QSR section translated to its ISO 13485 clause. The licence is per person: each consultant who uses the pack needs one, and handing the files to a client means the client buys their own.

Teams building a knowledge layer

The pack is a bundle of Markdown files with front matter and index pages, laid out so a retrieval index or an assistant can navigate and cite it. An AGENTS.md tells software assistants how to read, cite and refuse to invent.

Notion and Obsidian users

The Notion edition imports as nested pages with a properties table on each page; the self-assessment CSV becomes a database. The folder opens directly as an Obsidian vault.

Who wrote it

What it is not

See it

4 reference pages of the free sample, readable here as web pages. They are the same files as in the sample zip, front matter included.

The full folder tree of the pack, then the first lines of one page exactly as they appear in the files (01-qmsr/qmsr-at-a-glance.md).

Folder tree 
AGENTS.md
LICENSE.md
README.md
SOURCES.md
index.md
log.md
notion-import.md
01-qmsr/
  crosswalk-qsr-to-iso-13485.md
  definitions-precedence.md
  fda-supplements.md
  index.md
  milestones.md
  qmsr-at-a-glance.md
  retained-sections.md
  transition-checklist.md
02-fda-inspections/
  index.md
  inspection-readiness-checklist.md
  inspection-types.md
  priorities-and-risk-based-approach.md
  program-overview.md
  qms-areas-and-oafrs.md
  references.md
  regulatory-actions.md
  special-considerations.md
  what-the-investigator-asks-first.md
03-electronic-records/
  annex-11-requirements.md
  audit-trail-requirements.md
  implementation-checklist.md
  index.md
  part-11-requirements.md
  part-11-vs-annex-11.md
  references.md
  software-validation.md
04-regulatory-map/
  index.md
  instruments.md
  international-bodies.md
  overview.md
  jurisdictions/
    australia.md
    brazil.md
    canada.md
    china.md
    european-union.md
    index.md
    india.md
    japan.md
    singapore.md
    south-korea.md
    switzerland.md
    united-kingdom.md
    united-states.md
05-warning-letters/
  how-to-read-fda-warning-letters.md
  index.md
06-self-assessment/
  change-control.md
  design-and-development.md
  how-to-use-and-score.md
  index.md
  management-oversight.md
  measurement-analysis-and-improvement.md
  other-applicable-fda-requirements.md
  outsourcing-and-purchasing.md
  production-and-service-provision.md
  self-assessment.csv
07-audit-simulation/
  index.md
  mock-inspection-runbook.md
  question-bank.md
  scenario-01.md
  scenario-02.md
  scenario-03.md
  scenario-04.md
  scenario-05.md
  scenario-06.md
  scenario-07.md
  scenario-08.md
08-genai-in-gxp/
  ai-system-considerations.md
  index.md
  validation-evidence-checklist.md
09-glossary/
  index.md
  terms.md
A page, as shipped 
---
type: "concept"
title: "QMSR at a glance"
description: "The regulation's name, dates, incorporation of ISO 13485 by reference, the six retained sections and the three changes that matter."
source: "public"
date: "2026-11"
edition: "2026-11"
licence: "Individual licence, Edition 2026-11; see LICENSE.md"
resource: "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820"
sources:
  - {id: "ecfr-820", resource: "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820", title: "eCFR, 21 CFR Part 820"}
  - {id: "fr-final-rule", resource: "https://www.federalregister.gov/citation/89-FR-7496", title: "Federal Register, 89 FR 7496"}
tags: ["qmsr", "overview", "start-here"]
status: "stable"
---

# 21 CFR Part 820 at a glance

|  |  |
|---|---|
| Name | Quality Management System Regulation (QMSR), 21 CFR Part 820 |
| Published | 2 February 2024, as the final rule *Medical Devices; Quality System Regulation Amendments* (89 FR 7496) |
| In effect | 2 February 2026 |
| Incorporates by reference (21 CFR 820.7) | ISO 13485:2016(E), Medical devices - Quality management systems - Requirements for regulatory purposes, third edition, 1 March 2016 (for 820.1, 820.3, 820.10, 820.35 and 820.45); ISO 9000:2015(E), Quality management systems - Fundamentals and vocabulary, clause 3, Terms and definitions (for 820.3) |
| Replaces | the Quality System Regulation of 1996; its numbered sections are reserved and appear in this pack only as labelled cross-references |
| Inspected under | FDA Compliance Program 7382.850, Inspection of Medical Device Manufacturers, effective the same day ([the program as a PDF](https://www.fda.gov/media/80195/download); see [02-fda-inspections](../02-fda-inspections/index.md)) |
| Consequence of non-compliance | a device is adulterated under section 501(h) of the FD&C Act (21 CFR 820.10(e)) |

## How the regulation is built now

| Section | What it does |
|---|---|
| 21 CFR 820.1 Scope | Who is covered (manufacturers of finished devices for human use, including contract sterilizers, installers, relabelers, remanufacturers, repackers, specification developers and initial distributors of foreign entities), who is not (component manufacturers, blood establishments), how HCT/Ps regulated as devices are treated, that the FD&C Act and its other regulations control over any conflicting clause of the incorporated standard, refusal of imports, and exemptions and variances. |
| 21 CFR 820.3 Definitions | Imports the definitions of ISO 13485 and clause 3 of ISO 9000, adds six terms the standards do not define, and makes the FD&C Act's definitions and five further terms supersede the standards' correlating terms. See [definitions-precedence.md](definitions-precedence.md). |
| 21 CFR 820.7 Incorporation by reference | Names the two incorporated documents and their editions and says where they can be inspected or bought. |
| 21 CFR 820.10 Requirements for a quality management system | The operative requirement: document a QMS that complies with ISO 13485 and the rest of Part 820; link four clauses to other FDA regulations (UDI, tracking, medical device reporting, corrections and removals); apply ISO 13485 clause 7.3 (Design and development) to class II, class III and listed class I devices; apply ISO 13485 clause 7.5.9.2 (Particular requirements for implantable medical devices) to life-supporting and life-sustaining devices; adulteration on non-compliance. |
| 21 CFR 820.35 Control of records | Record contents FDA adds on top of ISO 13485 clause 4.2.5 (Control of records): complaint records, servicing records, UDI per device or batch, confidentiality marking. See [fda-supplements.md](fda-supplements.md). |
| 21 CFR 820.45 Device labeling and packaging controls | Labeling and packaging controls FDA adds on top of ISO 13485 clause 7.5.1 (Control of production and service provision): procedures, examination before release, documented release, mix-up prevention. See [fda-supplements.md](fda-supplements.md). |

All other section numbers of Part 820 are reserved. The [crosswalk](crosswalk-qsr-to-iso-13485.md) shows where each former section's subject now lives.

## Three things that changed

1. **The requirements live in the standard.** Instead of restating quality-system requirements, the regulation requires a QMS that complies with ISO 13485:2016 (21 CFR 820.10(a)). The standard's text is copyrighted and is not reproduced here or in the regulation; a manufacturer needs its own copy.
2. **FDA kept what the standard does not cover.** The retained sections carry the FDA-specific requirements: UDI, device tracking, medical device reporting and corrections and removals linked to named clauses (21 CFR 820.10(b)); the design and development applicability rule (820.10(c)); traceability for life-supporting devices (820.10(d)); complaint and servicing record contents (820.35); labeling and packaging controls (820.45).
3. **Definitions follow the Act.** Where the FD&C Act or 21 CFR 820.3 defines a term, that definition supersedes the standard's; the standard's "organization" is read as "manufacturer" and "safety and performance" as "safety and effectiveness" (21 CFR 820.3(b)).

## Where to read it

- [Current text of 21 CFR Part 820 on eCFR](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820)
- [Final rule, 89 FR 7496, 2 February 2024 (Federal Register)](https://www.federalregister.gov/citation/89-FR-7496)
- [FDA's QMSR page](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr)
- [Compliance Program 7382.850, current edition (PDF)](https://www.fda.gov/media/80195/download)
- [Compliance Program Manual (index of all compliance programs)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/compliance-program-manual)

---
*QMSR Knowledge Pack, Edition 2026-11. Professional reference material, not legal or regulatory advice. Licensed per person; see [LICENSE.md](../LICENSE.md).*

Formats

A purchase delivers all three; the checksums let you confirm the files you received are the ones the build produced.

FileBest forSize
Markdown bundle (zip)
sha256 de0ec6bd8ec7c78d27e0cde2e4dc4f556af2b9bdaa3171cb888dae16a88056aa
 Obsidian, Git, retrieval indexes and assistants. Folder layout with index.md per directory and a log.md with the edition note and the corrections by page; front matter on every page. 177 KB
Notion edition (zip)
sha256 48fb36593f28393d6746933b6ae0157c8fe216e61f6361c9cdf2cea376a814b0
 Notion import (Settings → Import → Text & Markdown). Pages are named by title, properties appear as a table at the top of each page, links are rewritten. 173 KB
Single Markdown file
sha256 28c558cb0cda2e94d0bcf869b1eab0ff7df04768742115267fbf80610d63d649
 Reading, printing, or pasting into a tool that takes one document. 383 KB

Buying

Written by Neelank Tiwari, MS, PMP, DEKRA ISO 13485 Lead Auditor, ASQ CMQ-OE, CQA, CMDA, CSQP, CQIA.

USD 129 per person for Edition 2026-11, with a personal licence that covers your own professional use, including inside tools you operate for yourself. Team licences are issued per named person. Checkout is by card through Stripe; the Markdown bundle, the Notion edition and the single file are delivered on the confirmation page and by email, with download links that stay valid for 30 days and can be re-sent to the purchase email at any time. Checkout runs on the seller's Stripe account, so the card statement reads KoalaT.ai.

Refunds. Full refund within 14 days of purchase if none of the files has been downloaded. Email tiwarineelank@gmail.com from the purchase address.

Seller: Koala Tea with Neel LLC. The licence is governed by the laws of the State of Illinois, United States; its full text is LICENSE.md inside the pack, and the free sample carries the same terms with "on download" in place of "on payment". Your name, email and purchase record are kept to deliver the files and handle refunds (see the privacy policy); card details go to Stripe and never touch this site.

USD 129, one-time

Sources

Every public source the pack relies on, with the access date. Regulation text quoted in the pack is from the eCFR (public domain); everything else is written in the pack's own words.

100 public sources

Questions

Does the pack contain the text of ISO 13485?
No. It cites clause numbers and the standard's table-of-contents titles. You need your own copy of the standard; the regulation requires a QMS that complies with it.
Is the regulation text in the pack official?
The pack quotes the six retained sections of 21 CFR Part 820 and two sections of Part 11 from the eCFR point-in-time text of 1 October 2026, marked as quotations. The eCFR itself is the official current text; links are given.
Can I load it into an AI assistant?
Yes, for your own use. The licence covers tools you operate for yourself. It does not cover a shared workspace or index that other people can read; they need their own licence.
Will it be updated?
No. Edition 2026-11 is a dated product and does not change after purchase; buying it carries no right to later editions and the seller takes on no obligation to publish one. If the regulations move enough to matter, a new edition may be published as a separate product with its own price.
What was it built from?
The eCFR, the Federal Register, FDA's published compliance program and web pages, the European Commission's Annex 11 and EUR-Lex, the twelve regulators' official sites, and pages written for the pack. The complete list with access dates is above and inside the pack.
Ask for a fresh set with the email you used at checkout at /pack/links.

QMSR Knowledge Pack, Edition 2026-11. Professional reference material, not legal or regulatory advice. Files generated on 2026-10-13 by a reproducible build; the checksums above identify them. Sold by Koala Tea with Neel LLC; the licence is governed by the laws of the State of Illinois, United States.