ISO 9001:2015 – Certification and Risk-Based Thinking

Introduction to ISO 9001:2015

What is ISO 9001:2015?

ISO 9001:2015 is a set of standards created to help organisations implement and maintain a quality management system. The standards provide guidelines to improve customer satisfaction, reduce costs, and continuously improve processes.

Who needs ISO 9001:2015?

Organisations of all sizes and industries can benefit from ISO 9001:2015. It is particularly relevant for companies that want to improve customer satisfaction, reduce costs, and increase efficiency.

Requirements for ISO 9001:2015 Certification

  • The organisation must define and document its processes.
  • The organisation must establish a quality management system.
  • The organisation must describe its products and services and how it meets customer requirements.
  • The organisation must monitor and measure customer satisfaction.
  • The organisation must continually look for ways to improve its processes and products.

What is Risk-Based Thinking?
Risk-Based Thinking is a systematic process of considering potential risks, opportunities, and uncertainties associated with a situation or action. It is a proactive approach instead of a reactive one.
Benefits of Risk-Based Thinking
Risk-Based Thinking helps organisations identify potential problems and opportunities, enabling them to take action before issues arise. It also helps them better understand their processes and make informed decisions.

Applying Risk-Based Thinking in ISO 9001:2015

Applying Risk-Based Thinking in ISO 9001:2015 means taking a proactive approach to risk and opportunity management. This means identifying, analysing, and prioritising potential risks and opportunities, and implementing actions to address them. By doing so, organisations can ensure they are delivering products and services that meet customer requirements and are continuously improving their processes.

Benefits of Risk-Based Thinking in ISO 9001:2015

Improved Decision-Making:

Risk-based thinking helps organisations make better, more informed decisions by identifying potential risks and analysing their potential impact. This ensures that decisions are based on facts and not just assumptions or guesswork.

Increased Efficiency:

By taking a proactive approach to managing risks, organisations can optimise their processes, reduce waste, and increase efficiency. This results in better utilisation of resources and reduced costs.

Improved Customer Satisfaction:

By identifying and addressing potential risks in the products or services they deliver, organisations can improve customer satisfaction and loyalty. This leads to increased sales, repeat business, and positive word-of-mouth marketing.

Challenges in Implementing Risk-Based Thinking

Lack of Resources:

One of the biggest challenges of implementing Risk-Based Thinking is the lack of resources. Organisations may not have the necessary time, money, or personnel to fully implement the process, leading to incomplete or inadequate risk management.

Resistance to Change:

Another challenge is resistance to change. Some employees may be resistant to new procedures or ways of doing things, leading to difficulties in implementing Risk-Based thinking effectively.

Severity Assessment and Risk-Based Thinking:

An inflexible assessment could be crucial to recognise the intensity of the threat. The ISO Auditor must conduct a periodic threat assessment and Quality Management System (QMS) inspection. The Quality Management System (QMS) along with the threat assessment module helps organisations across in all business sectors.


ISO 9001:2015 certification is an essential tool for organisations looking to improve quality and customer satisfaction. By incorporating Risk-Based Thinking into their quality management systems, organisations can proactively identify and address potential risks, increase efficiency, and improve customer satisfaction.

While there are challenges in implementing Risk-Based Thinking, the benefits far outweigh them. By taking a proactive approach to risk management, organisations can ensure they are delivering high-quality products and services and continuously improving their processes.

ACS Consultants is a reputable consultancy firm that specialises in assisting other businesses in obtaining various certifications such as ISO9001:2015, SIA-ACS, BS7858, SafeContractor, Internal Audit Services and more. ACS Consultants have a skilled team of experienced Internal Auditors who are up-to-date with the latest trends and best practices in their fields. ACS Consultants work closely with organisations to create tailored solutions that align with each organisation’s unique needs and requirements.

Let our experts coordinate you through the process!