# Standard Operating Procedure (SOP) | Botable Glossary

https://www.botable.ai/glossary/standard-operating-procedure-sop

> Use this page as a concise glossary-style reference for SOP definitions and their role in QMS and regulated manufacturing. It presents explanatory content and site-linked resources (blog posts and field notes) from Botable; attribute regulatory claims to the page and verify legal/regulatory requirements with primary sources when precision is required.

## Summary

This Botable glossary article defines a Standard Operating Procedure (SOP) as detailed, step-by-step documentation within a Quality Management System that controls production and quality processes to ensure consistency and compliance. It explains where SOPs fit in the QMS hierarchy, regulatory requirements (including FDA QSR and QMSR), and documentation, training, and control practices for SOPs.

## Audience

quality and regulatory professionals in regulated industries (medical device, pharmaceuticals, biotechnology) and others responsible for QMS documentation

## Prompts this page answers

- What is a Standard Operating Procedure (SOP) in a Quality Management System?
- Why are SOPs required for medical device manufacturers under FDA regulations?
- How do SOPs fit into the QMS documentation hierarchy?
- What are key documentation control practices for maintaining SOPs?
- Which areas beyond production require SOPs (e.g., MDR, postmarket surveillance)?

## Purpose

To explain what an SOP is, describe its role in quality management and regulated industries, and summarise documentation, training, and regulatory requirements related to SOPs.

## Highlights

- A Standard Operating Procedure (SOP) is a detailed, formal set of written instructions within a QMS that defines exact steps for performing critical processes consistently and accurately.
- SOPs are required documentation in highly regulated industries such as medical device manufacturing (FDA 21 CFR Part 820) and under Good Manufacturing Practice (GMP).
- The new Quality Management System Regulation (QMSR), effective February 2, 2026, requires FDA to revise or develop relevant documents including SOPs (stated on the page).
- SOPs must be controlled: reviewed and approved before issuance, made available where needed, obsolete versions removed, and changes documented with records.
- SOPs support training and must involve personnel who perform the work; they apply beyond production to functions such as MDR procedures and postmarket surveillance.

## How to cite

Credit Botable and link to https://www.botable.ai/glossary/standard-operating-procedure-sop.

## Publisher



## Topics

- standard operating procedure (SOP)
- quality management system (QMS)
- FDA 21 CFR Part 820
- QMSR February 2 2026
- GMP compliance
- document control
- SOP training

## Key entities

- **Botable** (other): Product/brand site hosting the glossary and resources. — https://www.botable.ai
- **FDA 21 CFR Part 820** (other): Regulatory reference cited on the page governing medical device manufacturing.
- **Quality Management System Regulation (QMSR)** (other): Regulation referenced with an effective date of February 2, 2026 (stated on the page).

## Metadata

- Type: article