# Risk-Based Thinking | Botable Glossary

https://www.botable.ai/glossary/risk-based-thinking

> Explanatory glossary/article content on a vendor site — useful as a concise definition and overview of RBT and its connections to ISO standards. Attribute claims to the Botable glossary when quoting; treat details as general guidance rather than normative regulatory text.

## Summary

Defines Risk-Based Thinking (RBT) as embedding risk-management principles throughout a Quality Management System (QMS) to proactively minimize negative effects and maximize opportunities, and explains its role in ISO 9001:2015, integration with PDCA, and connection to CAPA and ISO 13485.

## Prompts this page answers

- What is risk-based thinking in a Quality Management System?
- How does ISO 9001:2015 incorporate risk-based thinking?
- How does risk-based thinking relate to CAPA and preventive action?
- What are practical effects of applying risk-based thinking in a QMS?

## Purpose

Educate readers about the concept of risk-based thinking, its standards context (notably ISO 9001:2015), and how it is implemented within a QMS.

## Highlights

- Risk-Based Thinking embeds risk-management principles across the entire Quality Management System to prevent negative effects and seize opportunities.
- RBT was a key change introduced in the ISO 9001:2015 standard and is integrated with the Plan-Do-Check-Act (PDCA) cycle.
- RBT shifts risk responsibility across the organization rather than to a single 'risk manager'.
- Organizations must plan actions to address both risks and opportunities (ISO 9001:2015, Section 6).
- RBT supports CAPA and is a foundation for ISO 13485:2016’s requirement to consider risk throughout the QMS.

## How to cite

Botable Glossary — 'Risk-Based Thinking'. https://www.botable.ai/glossary/risk-based-thinking

## Publisher

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

## Topics

- risk-based thinking
- ISO 9001:2015
- quality management system
- CAPA
- ISO 13485:2016

## Key entities

- **Risk-Based Thinking (RBT)** (other): The glossary term defined on the page. — https://www.botable.ai/glossary/risk-based-thinking
- **ISO 9001:2015** (other): International standard cited as introducing RBT and requiring consideration of risks and opportunities (Section 6).
- **ISO 13485:2016** (other): Standard mentioned as requiring risk consideration throughout the QMS.
- **CAPA (Corrective and Preventive Action)** (other): Quality process that RBT supports, with preventive action emphasized.
- **PDCA (Plan-Do-Check-Act)** (other): Process cycle the page says RBT is integrated with under ISO 9001:2015.

## Metadata

- Type: article