Understanding ISO 9001:2015: What is Risk-Based Thinking?


Risk-based thinking is the cornerstone of ISO 9001:2015. It moves beyond the traditional corrective action approach and focuses on identifying, assessing, and mitigating risks proactively. 


This methodology ensures that quality management is not just reactive but is an integral part of strategic planning, leading to more resilient and agile businesses.


This guide will take a closer look at the facets and requirements of risk-based thinking, including: 


Identifying Risks: A Step-by-Step Guide

  • Risk Identification: This involves recognising potential risks that could impact the organisation’s ability to meet its objectives.
  • Risk Analysis: Once identified, these risks are analysed to determine their potential impact and likelihood of occurrence.
  • Risk Evaluation: Here, the significance of each risk is assessed to prioritise actions and resources.

Integrating Risk Management into Organisational Processes

ISO 9001:2015 encourages organisations to embed risk management into their core processes. This integration ensures that risk assessment is not an isolated activity but a continuous, all-encompassing process.


How Risk Management Benefits Different Aspects of an Organisation


  • Product Development: By foreseeing potential quality issues, organisations can save time and resources.


  • Quality Management: Identifying risks inherent in quality control processes helps in maintaining consistent product or service quality, thereby enhancing overall business performance.


  • Customer Satisfaction: Proactively addressing risks improves product quality and customer service, enhancing customer satisfaction.

Diagram: The ISO 9001:2015 Risk Management Process

Risk based Thinking

Implementing Risk-Based Thinking in ISO 9001:2015: A Practical Approach

Addressing Risks: Strategies and Solutions


The process of addressing risks in the context of ISO 9001:2015 involves a systematic approach to identifying, analysing, and mitigating potential threats to an organisation’s quality management system.


  • Preventative Action: This step involves taking proactive measures to prevent risks from becoming issues. It includes designing processes with built-in safeguards and continuously reviewing these for potential improvements.


  • Risk Mitigation Plans: Developing specific plans for identified risks ensures that the organisation is prepared to respond effectively. These plans include assigning responsibilities, setting timelines, and allocating resources.


  • Communication and Training: Ensuring that all employees know potential risks and how to respond is crucial. Regular training and clear communication channels are key to effective risk management.

Learning from Risks: Turning Challenges into Opportunities


ISO 9001:2015 not only focuses on mitigating risks but also on learning from them. By analysing incidents and near-misses, organisations can identify areas for improvement.


  • Root Cause Analysis: When an issue arises, conducting a root cause analysis helps understand the underlying factors. This understanding is crucial for implementing effective corrective actions.


  • Knowledge Sharing: Sharing lessons learned from risk events across the organisation promotes a culture of continuous learning and improvement.


  • Updating Processes and Policies: Based on the insights gained from risk events, updating relevant processes and policies helps in preventing recurrence and improving overall system robustness.

The Role of Technology in Enhancing Risk-Based Thinking

Incorporating technology can significantly streamline and enhance the effectiveness of risk-based thinking in an organisation’s quality management system.


  • ISO 9001 Software: Utilising specialised software created for ISO compliance can help in systematically tracking, analysing, and reporting risks.


  • Data Analytics: Leveraging data analytics enables organisations to identify patterns and trends, helping in proactive risk identification and management.


  • Process Mapping: Using process mapping tools helps in visualising and understanding workflows, thereby identifying potential areas of risk more effectively. This clarity aids in devising targeted strategies for risk mitigation.

Establishing a Risk-Aware Culture

Creating a risk-aware culture is fundamental to the successful implementation of risk-based thinking following ISO 9001:2015.


  • Leadership Commitment: The commitment of top management to a risk-aware culture sets the tone for the entire organisation.


  • Employee Engagement: Encouraging employee participation in risk identification and mitigation fosters a sense of ownership and responsibility.


  • Regular Reviews and Feedback: Continually reviewing risk management practices and encouraging feedback ensures that the system evolves and remains effective.

The Next Steps

ISO 9001:2015 is more than a set of requirements; it is a strategic tool that embeds quality and risk management into the DNA of an organisation. 


Organisations aiming to implement ISO 9001:2015 are positioned to thrive in an ever-evolving business landscape, turning potential risks into opportunities for growth and innovation. 


Take the first steps to certification today by booking a demo of the Agility System, our ISO 9001-compliant management system software. 

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Picture of Peter Shields
Peter Shields
Peter is a Quality, Risk & Compliance expert with extensive experience working with process-based management systems in the Energy, Nuclear & Defence sectors since 1979.
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