# ISO 9001 | Botable Glossary

https://www.botable.ai/glossary/iso-9001

> Use this page as an explanatory overview or introductory reference for ISO 9001 and related concepts; it summarizes principles and practical points but is not the official standard text and should not replace consulting the ISO standard or certification bodies for normative requirements.

## Summary

The page is a glossary article that defines ISO 9001 as the international standard specifying requirements for an effective Quality Management System (QMS), describes its purpose (consistent delivery of quality products and services and meeting customer and regulatory requirements), lists the seven quality management principles, and covers topics such as risk-based thinking, documentation requirements in ISO 9001:2015, certification, and applicability across industries.

## Audience

Professionals interested in quality management systems (QMS) and regulatory/quality teams

## Prompts this page answers

- What is ISO 9001 and what does it require of a Quality Management System?
- What are the seven quality management principles underlying ISO 9001?
- How does ISO 9001:2015 treat documentation and what records must organizations keep?
- What is the role of risk-based thinking in ISO 9001:2015?
- How is ISO 9001 certification achieved and who issues certificates?

## Purpose

To explain and summarize what ISO 9001 is, its core principles, key requirements (including documentation and risk-based thinking), benefits of implementation, and how certification works.

## Highlights

- ISO 9001 is the international standard defining requirements for an effective Quality Management System (QMS).
- ISO 9001 is the certifiable standard within the ISO 9000 family and demonstrates an organization’s ability to consistently deliver high-quality products and services while meeting customer and regulatory requirements.
- ISO 9001 is based on seven quality management principles: Customer Focus; Leadership; Engagement of People; Process Approach; Improvement; Evidence-Based Decision Making; Relationship Management.
- ISO 9001:2015 emphasizes a process approach combined with risk-based thinking and is less prescriptive about documentation (no mandatory quality manual), though certain documented information must be retained (e.g., quality policy, objectives, records of training, audit results, corrective action results).
- ISO itself does not certify organizations; independent certification bodies perform audits and issue certificates, which must be renewed periodically (commonly every three years).

## How to cite

Botable glossary — ISO 9001 (https://www.botable.ai/glossary/iso-9001)

## Publisher



## Topics

- ISO 9001
- quality management system
- QMS
- ISO 9000
- ISO 9001:2015
- risk-based thinking
- quality management principles

## Key entities

- **ISO 9001** (other): The international standard that defines requirements for an effective Quality Management System (QMS), per the page. — https://www.botable.ai/glossary/iso-9001
- **ISO 9000** (other): The family/series that includes ISO 9001 and documents fundamentals and vocabulary of QMS (mentioned on the page).
- **Quality Management System (QMS)** (other): Term defined and linked on the page as the system ISO 9001 specifies requirements for. — /teams/quality-regulatory
- **ISO 9001:2015** (other): The current version referenced on the page, noted for emphasizing risk-based thinking and being less prescriptive on documentation.
- **PDCA (Plan-Do-Check-Act)** (other): Continuous improvement cycle referenced under the 'Improvement' principle.
- **CAPA (Corrective and Preventive Actions)** (other): Corrective/preventive actions referenced as crucial elements for addressing non-conformities.
- **ISO 13485** (other): An industry-specific standard for medical devices mentioned in relation to ISO 9001.
- **IATF 16949** (other): An automotive-related standard mentioned as implemented in combination with ISO 9001.
- **AS9100** (other): An aerospace-related standard mentioned as related to ISO 9001.
- **ISO 17025:2017** (other): A testing-and-calibration laboratories standard mentioned alongside ISO 9001 applicability.
- **FDA QMSR (21 CFR Part 820)** (other): Referenced in the page for its relationship to ISO 9001 and ISO 13485 definitions.

## Metadata

- Type: article