The FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, took effect February 2, 2026; it requires finished-device manufacturers to establish and maintain a quality management system and incorporates ISO 13485:2016 by reference. This page is for manufacturers whose quality lead wants help with one bounded part of the QMSR transition: document control, records and governance. Under your quality lead, Integral Healthcare Solutions (IHS) drafts document-control and governance procedures; your device specialists own design, manufacturing and validation.

Last reviewed: October 2026.

What is the FDA QMSR?

FDA states: “The rule is effective February 2, 2026, and is now titled Quality Management System Regulation (QMSR).” and “The QMSR incorporates by reference the international standard, ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes.” (source)

The regulation names the edition. 21 CFR 820.7(b) incorporates “ISO 13485:2016(E) (“ISO 13485”), Medical devices—Quality management systems—Requirements for regulatory purposes, Third edition, March 1, 2016; IBR approved for §§ 820.1, 820.3, 820.10, 820.35, and 820.45.” (source) Section 820.7(a) incorporates ISO 9000:2015(E) Clause 3 for definitions (source).

The core duty sits in 820.1(a): “Any manufacturers engaged in the design, manufacture, packaging, labeling, storage, installation, or servicing of a finished device must establish and maintain a quality management system that is appropriate for its specific device(s).” (source) Section 820.10(a) requires manufacturers to “Document a quality management system that complies with the applicable requirements of ISO 13485 (incorporated by reference, see § 820.7) and other applicable requirements of this part” (source).

Part 820 also adds to ISO 13485 on records. Section 820.35 reads: “In addition to the requirements of Clause 4.2.5 in ISO 13485 (incorporated by reference, see § 820.7), Control of Records, the manufacturer must include the following information in certain records” (source). That is the part of the regulation closest to the workstream IHS supports.

Who needs it and what triggers it?

FDA says: “The QMSR regulation applies to finished device manufacturers who intend to commercially distribute medical devices.” (source) Triggers named in the sources:

• The effective date. QMSR took effect February 2, 2026 (source), so procedures written to the old regulation need to be checked against Part 820 as it now reads and against ISO 13485.
• A change in how FDA inspects. “On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers Compliance Program: 7382.850.” (source)
• Records requirements beyond ISO 13485, in 820.35 (source).

QMSR is mandatory for manufacturers in scope; it is not an accreditation a manufacturer chooses to pursue (source).

How IHS helps

IHS works only a bounded document-control and governance workstream, under your quality lead. The work runs in this order:

1. Gap assessment of document control, records and management-review records against the QMSR text and the ISO 13485 clauses your organization holds a licensed copy of.
2. Document and evidence mapping: each requirement in that workstream crosswalked to the procedure or record that answers it.
3. Drafting: document-control and records procedures and a governance calendar, for your quality lead to review and approve.
4. A mock document audit of that workstream.

What your organization supplies: the quality manual, current procedures, a licensed copy of ISO 13485, a technical lead who owns the QMS, and your device specialists.

The limit, stated plainly: design controls, manufacturing, process validation and the quality management system as a whole belong to device quality specialists. IHS has no device-QMS depth beyond this workstream. IHS does not deal with FDA; your organization handles all FDA interaction, including inspections.

What to have ready

Each item ties to the QMSR text or FDA’s QMSR pages. The regulation and your licensed copy of ISO 13485 govern.

1. A licensed copy of ISO 13485:2016(E), Third edition, the edition Part 820 incorporates (21 CFR 820.7(b)).
2. Access to ISO 9000:2015(E) Clause 3 for the definitions the regulation incorporates (21 CFR 820.7(a)).
3. A list of the finished devices you intend to commercially distribute (FDA QMSR page).
4. A statement of which activities you perform: design, manufacture, packaging, labeling, storage, installation or servicing (21 CFR 820.1(a)).
5. Your documented quality management system: the quality manual and current procedures (21 CFR 820.10(a)).
6. Your control-of-records procedure, checked against ISO 13485 Clause 4.2.5 (21 CFR 820.35).
7. The added record content 820.35 requires in certain records, mapped to where each item is captured (21 CFR 820.35).
8. An inspection-readiness plan written for Compliance Program 7382.850, not QSIT (FDA QMSR page).
9. If you are audited under MDSAP, your MDSAP audit reports (FDA MDSAP page).

To walk through this list against your own document-control workstream, start with the introductory call.

How it compares

Manufacturers look at several routes for QMSR work. What the sources say about each:

• MDSAP. FDA says: “The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.” and “The FDA may continue to accept MDSAP audit reports as a substitute for routine Agency inspections.” (source)
• ISO 13485 certification from a certification body. This is a voluntary certificate. The FDA pages IHS reviewed do not say how FDA treats an ISO 13485 certificate under QMSR.
• Device quality specialist firms. Firms that work the full quality management system, including design controls and process validation, cover what IHS does not.
• No compliance. Not an option for a manufacturer in scope: 820.1(a) says such manufacturers “must establish and maintain a quality management system” (source).

IHS’s other compliance work is listed on the Compliance Services page.

What does QMSR compliance cost?

FDA does not publish a fee schedule for QMSR on the pages we reviewed. QMSR is a regulation, not a program a manufacturer applies to, so the cost depends on the scope of work needed to meet it. IHS scopes each engagement after a free introductory call.

What this is not

• IHS does not build or run your quality management system, design controls, manufacturing or process validation. That is device quality specialist work.
• IHS does not deal with FDA, and nothing IHS drafts predicts the outcome of an FDA inspection.
• This page is not legal or regulatory advice.

Frequently asked questions

What is the FDA QMSR and when did it take effect?

The Quality Management System Regulation is FDA's device quality rule at 21 CFR Part 820. FDA states the rule is effective February 2, 2026, and that it incorporates ISO 13485:2016 by reference.

How is QMSR different from the old Quality System Regulation (QSR)?

FDA says the amended rule is now titled the Quality Management System Regulation and incorporates ISO 13485:2016 by reference. Part 820 now requires a documented quality management system that complies with the applicable requirements of ISO 13485 and other requirements of the part. FDA also replaced QSIT with Compliance Program 7382.850 for inspections on the same date.

Does QMSR mean we must be ISO 13485 certified?

Section 820.10(a) requires a documented quality management system that complies with the applicable requirements of ISO 13485. The FDA pages IHS reviewed do not say that a certificate from a certification body is required, or how FDA treats one. Confirm with your regulatory lead.

Which edition of ISO 13485 does QMSR incorporate?

21 CFR 820.7(b) incorporates ISO 13485:2016(E), Third edition, March 1, 2016. Section 820.7(a) incorporates ISO 9000:2015(E) Clause 3 for definitions.

Who does QMSR apply to: contract manufacturers, relabelers, specification developers?

FDA says QMSR applies to finished device manufacturers who intend to commercially distribute medical devices. Section 820.1(a) covers manufacturers engaged in the design, manufacture, packaging, labeling, storage, installation or servicing of a finished device. How that applies to a specific business model is a question for your regulatory lead; IHS does not give that opinion.

What replaced QSIT for FDA device inspections?

FDA says that on February 2, 2026, it stopped using the Quality System Inspection Technique and began using the inspection process in the updated Inspection of Medical Device Manufacturers Compliance Program, 7382.850.

What does QMSR add on top of ISO 13485 for records?

Section 820.35 says that, in addition to ISO 13485 Clause 4.2.5, Control of Records, the manufacturer must include specified information in certain records. Read the full list in 820.35 itself. IHS maps each item to the record where it is captured.

Can an MDSAP audit substitute for a routine FDA inspection?

FDA says it may continue to accept MDSAP audit reports as a substitute for routine Agency inspections. MDSAP lets a recognized Auditing Organization conduct a single regulatory audit that satisfies the participating regulators.

What document-control and records should be in place before an FDA inspection under QMSR?

Start with a documented quality management system under 820.10(a), a control-of-records procedure that meets ISO 13485 Clause 4.2.5, and the added record content in 820.35. Plan for the 7382.850 inspection process, not QSIT. IHS drafts the document-control and records procedures and runs a mock document audit of that workstream.