# Quality Procedure | Botable Glossary

https://www.botable.ai/glossary/quality-procedure

> Use as a vendor-hosted glossary/article that provides a concise, explanatory definition and practical guidance about Quality Procedures; attribute regulatory claims to the page when quoting and corroborate regulatory specifics from primary regulatory texts where required.

## Summary

Defines a Quality Procedure as a controlled document in a Quality Management System that specifies who does what, how, when, and where, explains its place in the QMS documentation hierarchy, lists typical procedure elements, and summarizes relevant regulatory requirements for regulated industries.

## Audience

Quality and regulatory professionals in regulated industries (e.g., medical device, pharmaceuticals, biotechnology)

## Prompts this page answers

- What is a Quality Procedure in a Quality Management System?
- What elements should be included in a Quality Procedure?
- How do Quality Procedures fit into the QMS documentation hierarchy?
- Are procedures mandatory under FDA QSR/QMSR and ISO 9001:2015?

## Purpose

To explain and define what a Quality Procedure is, describe its role within QMS documentation, and outline typical content and regulatory expectations.

## Highlights

- Quality Procedure is a controlled document that specifies who performs what steps, how, when, and where within a QMS process.
- Procedures occupy the middle tier of the QMS documentation hierarchy between Quality Policy/Manual and Work Instructions/Records.
- Regulated environments (e.g., medical device manufacturing) require documented procedures under FDA QSR/QMSR and related regulations.
- Typical procedure elements include title, purpose, scope, responsibilities, description of activities, document control, definitions, records, and appendices.
- ISO 9001:2015 has no mandatory procedures, though organizations commonly maintain procedures to ensure process conformity.

## How to cite

Botable glossary — “Quality Procedure”, Botable. https://www.botable.ai/glossary/quality-procedure

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- quality procedure
- QMS documentation hierarchy
- quality management system
- FDA QSR QMSR
- ISO 9001 procedures

## Key entities

- **Quality Management System (QMS)** (other): Referenced as the system in which Quality Procedures are used. — /teams/quality-regulatory
- **FDA QSR / QMSR** (organization): Regulatory framework referenced for mandatory documented procedures (21 CFR Part 820 and later QMSR references).
- **ISO 9001:2015** (other): Standard noted for having no mandatory procedures in its 2015 revision.
- **HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products)** (other): Regulated product category cited with specific procedural requirements.
- **CAPA (Corrective and Preventive Action)** (other): Process referenced in the context of recording changes to methods and procedures.

## Metadata

- Type: article