QMS areas and other applicable FDA requirements
The six QMS areas and four other applicable FDA requirements in Compliance Program 7382.850, each with its elements and the clauses and sections evaluated.
About this page
- Type
- Concept page
- Source
- Summarises public material (regulation, guidance or an official site)
- Edition
- Edition 2026-11
- Primary source
- www.fda.gov
- Sources
-
FDA Compliance Program 7382.850 (PDF)
FDA Compliance Program Manual - Tags
- inspections, qms-areas
- Status
- Stable
- Licence
- Individual licence, Edition 2026-11; see LICENSE.md
Front matter, as shipped
---
type: "concept"
title: "QMS areas and OAFRs"
description: "The six QMS areas and four other applicable FDA requirements in Compliance Program 7382.850, each with its elements and the clauses and sections evaluated."
source: "public"
date: "2026-11"
edition: "2026-11"
licence: "Individual licence, Edition 2026-11; see LICENSE.md"
resource: "https://www.fda.gov/media/80195/download"
sources:
- {id: "cp-7382-850", resource: "https://www.fda.gov/media/80195/download", title: "FDA Compliance Program 7382.850 (PDF)"}
- {id: "cpm-home", resource: "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/compliance-program-manual", title: "FDA Compliance Program Manual"}
tags: ["inspections", "qms-areas"]
status: "stable"
---
Free sample of the QMSR Knowledge Pack, Edition 2026-11, published here by Koala Tea with Neel LLC. Reading this page needs no licence; the download and the full pack are licensed per person.
The program organises an inspection around six QMS areas and four other applicable FDA requirements (OAFRs). Each area is a set of elements, and each element names the ISO 13485:2016 clauses, and where relevant the 21 CFR Part 820 sections, that the investigator evaluates (Attachment A of the program). Under Inspection Model 1 at least one element of every area and every OAFR is covered; under Model 2 the program fixes the minimum elements (see priorities-and-risk-based-approach.md (full pack)). Clause titles are the standard's table of contents; the clause text is not reproduced.
The six QMS areas
Change Control (CC)
Purpose: Changes are evaluated for risk and for their effect on products and processes before they are made.
| Element | Requirements evaluated |
|---|---|
| QMS Changes | ISO 13485 clause 4.1.4 (within 4.1, General requirements), ISO 13485 clause 4.2.4 (Control of documents), ISO 13485 clause 4.2.5 (Control of records), ISO 13485 clause 5.4.2 (Quality management system planning), ISO 13485 clauses 5.6.1 to 5.6.3 (Management review) and ISO 13485 clause 8.5.1 (General) |
| Software Changes | ISO 13485 clause 4.1.6 (within 4.1, General requirements), ISO 13485 clause 7.5.6 (Validation of processes for production and service provision) and ISO 13485 clause 7.6 (Control of monitoring and measuring equipment) |
| Product and Process Changes | ISO 13485 clause 4.1.4 (within 4.1, General requirements), ISO 13485 clause 7.2.2 (Review of requirements related to product), ISO 13485 clause 7.3.9 (Control of design and development changes), ISO 13485 clause 7.3.10 (Design and development files), ISO 13485 clause 7.5.6 (Validation of processes for production and service provision) and ISO 13485 clause 7.5.7 (Particular requirements for validation of processes for sterilization and sterile barrier systems) |
| Purchasing Changes | ISO 13485 clause 7.4.2 (Purchasing information) and ISO 13485 clause 7.4.3 (Verification of purchased product) |
Design and Development (D&D)
Purpose: Design and development produces a safe and effective device that meets its intended use.
| Element | Requirements evaluated |
|---|---|
| Customer Related Processes | 21 CFR 820.10(b)(4); ISO 13485 clauses 7.2.1 to 7.2.3 (Customer-related processes) |
| Design and Development General | ISO 13485 clause 7.3.1 (General) |
| Design and Development Planning | ISO 13485 clause 7.3.2 (Design and development planning) |
| Design and Development Inputs | ISO 13485 clause 7.3.3 (Design and development inputs) |
| Design and Development Outputs | ISO 13485 clause 7.3.4 (Design and development outputs) |
| Design and Development Review | ISO 13485 clause 7.3.5 (Design and development review) |
| Design and Development Verification | ISO 13485 clause 7.3.6 (Design and development verification) |
| Design and Development Software Validation | ISO 13485 clause 7.3.7 (Design and development validation) |
| Design and Development Validation | ISO 13485 clause 7.3.7 (Design and development validation) |
| Design and Development Transfer | ISO 13485 clause 7.3.8 (Design and development transfer) |
| Control of Design and Development Changes | ISO 13485 clause 7.3.9 (Control of design and development changes) |
| Design and Development Files | ISO 13485 clause 7.3.10 (Design and development files) |
Management Oversight (MO)
Purpose: Top management plans, establishes and maintains an effective QMS with the resources to design, make and distribute safe and effective devices, and uses risk management and risk-based decisions in running it.
| Element | Requirements evaluated |
|---|---|
| Quality Management System | ISO 13485 clauses 4.1.1 to 4.1.4 (General requirements) |
| Risk-based Approach | ISO 13485 clause 4.1.2 (within 4.1, General requirements) |
| QMS Software Validation | ISO 13485 clause 4.1.6 (within 4.1, General requirements) |
| Quality Manual | ISO 13485 clause 4.2.2 (Quality manual) |
| Medical Device File | ISO 13485 clause 4.2.3 (Medical device file) |
| Control of Documents and Records | 21 CFR 820.35; 21 CFR 820.45; ISO 13485 clause 4.2.1 (General), ISO 13485 clause 4.2.4 (Control of documents) and ISO 13485 clause 4.2.5 (Control of records) |
| Management Commitment | ISO 13485 clause 5.1 (Management commitment) |
| Customer Focus | ISO 13485 clause 5.2 (Customer focus) |
| Quality Policy, Quality Objectives, Quality Management System Planning | ISO 13485 clause 5.3 (Quality policy), ISO 13485 clause 5.4.1 (Quality objectives) and ISO 13485 clause 5.4.2 (Quality management system planning) |
| Responsibility, Authority, and Communication | ISO 13485 clauses 5.5.1 to 5.5.3 (Responsibility, authority and communication) |
| Management Review | ISO 13485 clauses 5.6.1 to 5.6.3 (Management review) |
| Provision of Resources | ISO 13485 clause 6.1 (Provision of resources) |
| Human Resources | ISO 13485 clause 6.2 (Human resources) |
| Planning of Product Realization | ISO 13485 clause 7.1 (Planning of product realization) |
Measurement, Analysis, and Improvement (MA&I)
Purpose: Monitoring, measurement, analysis and improvement find and reduce the risks that affect the product and the QMS.
| Element | Requirements evaluated |
|---|---|
| Measurement, Analysis, and Improvement - General | ISO 13485 clause 8.1 (General) and ISO 13485 clause 8.5.1 (General) |
| Feedback | ISO 13485 clause 8.2.1 (Feedback) |
| Complaint Handling | 21 CFR 820.10(b)(3); 21 CFR 820.10(b)(4); 21 CFR 820.35; ISO 13485 clause 8.2.2 (Complaint handling) and ISO 13485 clause 8.2.3 (Reporting to regulatory authorities) |
| Internal Audits | ISO 13485 clause 8.2.4 (Internal audit) |
| Monitoring and Measurement of Processes | ISO 13485 clause 8.2.5 (Monitoring and measurement of processes) |
| Monitoring and Measurement of Product | ISO 13485 clause 8.2.6 (Monitoring and measurement of product) |
| Control of Nonconforming Product | 21 CFR 820.10(b)(4); ISO 13485 clauses 8.3.1 to 8.3.4 (Control of nonconforming product) |
| Analysis of Data | ISO 13485 clause 8.4 (Analysis of data) |
| Corrective Action | ISO 13485 clause 8.5.2 (Corrective action) |
| Preventive Action | ISO 13485 clause 8.5.3 (Preventive action) |
Outsourcing and Purchasing (O&P)
Purpose: Outsourced processes and activities and purchased product are monitored and controlled so that product conforms to its requirements.
| Element | Requirements evaluated |
|---|---|
| Outsourcing | ISO 13485 clause 4.1.5 (within 4.1, General requirements) |
| Purchasing Process | ISO 13485 clause 7.4.1 (Purchasing process) |
| Purchasing Information and Purchased Product | ISO 13485 clause 7.4.2 (Purchasing information) and ISO 13485 clause 7.4.3 (Verification of purchased product) |
Production and Service Provision (PS)
Purpose: Planning, monitoring and control of production and servicing result in a safe and effective device.
| Element | Requirements evaluated |
|---|---|
| Infrastructure and Maintenance | ISO 13485 clause 6.3 (Infrastructure) |
| Work Environment and Contamination Control | ISO 13485 clause 6.4.1 (Work environment) and ISO 13485 clause 6.4.2 (Contamination control) |
| Control of Production and Service Provision | 21 CFR 820.35; 21 CFR 820.45; ISO 13485 clause 7.5.1 (Control of production and service provision) |
| Cleanliness of Product | ISO 13485 clause 7.5.2 (Cleanliness of product) |
| Installation and Servicing Activities | 21 CFR 820.35; ISO 13485 clause 7.5.3 (Installation activities) and ISO 13485 clause 7.5.4 (Servicing activities) |
| Validation of Processes for Production and Service Provision | ISO 13485 clause 7.5.6 (Validation of processes for production and service provision) |
| Sterile Medical Devices and Validation of Processes for Sterilization and Sterile Barrier Systems | ISO 13485 clause 7.5.5 (Particular requirements for sterile medical devices) and ISO 13485 clause 7.5.7 (Particular requirements for validation of processes for sterilization and sterile barrier systems) |
| Identification and Traceability | 21 CFR 820.10(b)(1); 21 CFR 820.10(b)(2); 21 CFR 820.35; 21 CFR 820.45; ISO 13485 clause 7.5.8 (Identification), ISO 13485 clause 7.5.9.1 (General) and ISO 13485 clause 7.5.9.2 (Particular requirements for implantable medical devices) |
| Customer Property | ISO 13485 clause 7.5.10 (Customer property) |
| Preservation of Product | ISO 13485 clause 7.5.11 (Preservation of product) |
| Control of Monitoring and Measuring Equipment | ISO 13485 clause 7.6 (Control of monitoring and measuring equipment) |
The four other applicable FDA requirements (OAFRs)
| Requirement | PAC | Regulation | Linked to the QMS by | What is checked |
|---|---|---|---|---|
| Medical Device Reporting | 81011 | 21 CFR Part 803 | 21 CFR 820.10(b)(3) | Device-related deaths, serious injuries and malfunctions were identified, investigated, reported and documented on time. |
| Reports of Corrections and Removals | 81850R | 21 CFR Part 806 | 21 CFR 820.10(b)(4) | FDA was promptly told of corrections and removals made to reduce a risk to health or to remedy a violation that may present one. |
| Medical Device Tracking Requirements | 81850T | 21 CFR Part 821 | 21 CFR 820.10(b)(2) | Devices subject to tracking can be located and removed quickly and their patients notified. |
| Unique Device Identification | 82016 | 21 CFR Part 801 Subpart B and Part 830 | 21 CFR 820.10(b)(1); 21 CFR 820.45 | A UDI is assigned as required and the device information is correctly submitted to GUDID. |
Using the areas
The self-assessment in 06-self-assessment (full pack), the question bank in 07-audit-simulation (full pack), what-the-investigator-asks-first.md (full pack) and the readiness checklist (full pack) are organised by these same areas and OAFRs, so a weak score points at the part of an inspection where the firm is exposed.
QMSR Knowledge Pack, Edition 2026-11. Professional reference material, not legal or regulatory advice. Licensed per person; see LICENSE.md.
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