Raising business quality to Six Sigma Level: Integrating effectively with ISO 9001

Introduction

Quality is a fundamental aspect in the success of any organization in today’s business landscape. The Six Sigma methodology has proven to be a powerful tool for improving quality and efficiency in business processes. On the other hand, the ISO 9001 standard is recognized worldwide as a framework for establishing and maintaining effective quality management systems. In this context, Six Sigma and ISO 9001 are fundamental approaches for achieving operational efficiency and quality improvement; their integration is key nowadays.

This article discusses the importance of raising quality to the Six Sigma level and how effective integration with ISO 9001 can enhance an organization’s quality improvement efforts.

Understanding Six Sigma

Six Sigma is more than just a quality improvement methodology; it is a business philosophy that aims to achieve perfection in processes by reducing defects and minimizing variability (The Council for Six Sigma Certification, 2018). This methodology relies heavily on data and statistical analysis to identify areas for improvement and make informed decisions.

The Six Sigma methodology is supported by a structured approach known as DMAIC, which consists of five phases (Pande, P., Neuman, R., Cavanagh, R.; 2012):

• In the Define phase, project objectives are established, and the scope is defined.
• In the Measure phase, relevant data and metrics are collected to assess the current process performance.
• The Analyze phase involves data analysis to identify the root causes of problems or defects.
• Once these causes are identified, the Improve phase is entered, where solutions are implemented to eliminate them.
• Finally, in the Control phase, measures are established to monitor and sustain the achieved improvements.

The goal of Six Sigma is to achieve a level of quality where the process produces no more than 3.4 defects per million opportunities, which equates to a performance level of 99.99966%. This high precision and consistency in processes allow organizations to reduce costs, increase customer satisfaction, and enhance their competitive position in the market.

Some of the tools and techniques used in Six Sigma include Pareto Analysis, Cause and Effect Diagram (Ishikawa), 5 Whys, process characterization and flowchart diagrams, linear regression, and design of experiments, among others. These tools provide project teams with the ability to identify issues, analyze data, and make informed decisions to improve the quality and operational efficiency of processes.

ISO 9001: Fundamentals and benefits

ISO 9001 is an internationally recognized standard that sets the requirements for an effective quality management system in an organization. Its objective is to provide a solid framework to help companies improve the quality of their products and services, as well as customer satisfaction.

At the core of ISO 9001 are several fundamental principles of quality management as outlined in ISO 9000:2015, including a strong customer focus. This means that organizations must understand and meet the requirements and expectations of their customers, as well as continuously seek ways to improve their satisfaction.

Another central principle of ISO 9001 is the process-based approach. This involves understanding and managing interrelated activities as a system, allowing an organization to optimize its processes and enhance its efficiency.

Furthermore, ISO 9001 emphasizes the importance of continuous improvement. Organizations establish quality objectives, monitor performance, and take action to address any deviations or non-conformities. This ensures that the quality management system is constantly evolving and improving over time.

Organizations that choose to implement the ISO 9001 Standard achieve a range of benefits, both internal and external. Firstly, it provides a quality assurance to customers and other stakeholders. The ISO 9001 Standard helps demonstrate the organization’s commitment to quality and can help build trust and credibility in the market.

Additionally, ISO 9001 guides organizations to reduce costs and improve operational efficiency. By establishing clear and documented processes, organizations can identify and eliminate unnecessary or redundant activities, leading to increased productivity and profitability.

Implementing an ISO 9001 quality management system can also enhance consistency and cohesion within an organization. By standardizing processes and procedures across the organization, ISO 9001 can facilitate communication and collaboration among different departments and functions.

The synergy between Six sigma and ISO 9001

The integration of Six Sigma and ISO 9001 is a powerful approach that combines the principles of both methodologies to drive excellence in quality and operational efficiency. These two quality management systems share common goals but have slightly different approaches, making them highly complementary when effectively implemented together.

Six Sigma methodology focuses on reducing variability and continuously improving processes to achieve an exceptional level of quality. It utilizes a data-driven approach and statistical analysis to identify and eliminate defects, resulting in greater consistency and predictability in the production of goods and services.

On the other hand, ISO 9001 sets requirements for an effective quality management system in an organization within the framework of quality management principles. Although ISO 9001 does not prescribe specific methods for achieving quality improvement, it provides a solid framework for establishing efficient processes and ensuring customer satisfaction.

When integrated effectively, Six Sigma and ISO 9001 complement each other in several ways:

• Focus on Continuous Improvement: Both methodologies have a strong emphasis on continuous process improvement. Six Sigma provides specific tools and techniques to identify and eliminate defects, while ISO 9001 establishes a framework for setting quality objectives, measuring performance, and taking action to address any deviations.
• Customer Orientation: Both Six Sigma and ISO 9001 are customer-centric. Six Sigma seeks to understand and meet customer needs by reducing defects and improving quality, while ISO 9001 requires organizations to understand and comply with customer requirements and expectations.
• Process-based Approach: These methodologies promote a process-based approach to quality management. Six Sigma analyzes and optimizes processes to reduce variability and improve quality, while ISO 9001 sets requirements for documentation and process management within an organization.

Together, this integration can enhance an organization’s quality improvement efforts by combining specific tools and techniques with a solid quality management framework, including statistical process control. This synergy can help organizations achieve exceptional levels of quality and operational efficiency, resulting in increased customer satisfaction and a competitive advantage in the market.

Benefits of integration

The effective integration of Six Sigma and ISO 9001 offers several significant benefits for organizations seeking to improve their quality and operational efficiency. By combining the principles and tools of both methodologies, organizations can leverage their resources to the fullest and maximize results. Below are some key benefits of this integration:

• Quality improvement: The combination of Six Sigma and ISO 9001 enables organizations to systematically identify and eliminate defects, leading to a significant improvement in the quality of products and services. By using statistical tools and data analysis, organizations can better understand the factors contributing to variability in processes and take steps to reduce it.
• Cost reduction: By improving the quality and efficiency of processes, organizations can reduce costs associated with rework, waste, and errors. Integrating allows organizations to identify and eliminate unnecessary or redundant activities, resulting in significant long-term savings.
• Increasecustomer satisfaction: The superior quality of products and services resulting from the integration leads to higher customer satisfaction. By consistently meeting customer requirements and expectations, organizations can enhance customer loyalty and strengthen their reputation in the market.
• Process optimization: The Six Sigma methodology provides specific tools and techniques for analyzing and optimizing processes, while ISO 9001 establishes a framework for process documentation and management. By integrating these approaches, organizations can identify areas for improvement and take action to optimize operational efficiency and productivity.
• Culture of continuous improvement: The integration promotes a culture of continuous improvement throughout the organization. By setting quality objectives, measuring performance, and taking action to address any deviations, organizations can encourage collaboration and employee engagement in the pursuit of quality excellence.

Considerations for Implementation

The effective implementation of Six Sigma and ISO 9001 approaches requires careful planning and execution. Here are some key considerations to keep in mind during this process:

• Commitment from management: The support and active involvement of top management are essential for the success of the integration. It’s important that organizational leaders understand the potential benefits of integration and are committed to its implementation.
• Definition of objectives and success metrics: It’s important to establish clear and measurable objectives for integration, as well as define the metrics that will be used to evaluate success. These objectives and metrics should be aligned with the organization’s strategic goals and focused on improving quality and operational efficiency.
• Training and development of personnel: Integrating Six Sigma and ISO 9001 will require organizational personnel to acquire new skills and knowledge. It’s important to provide adequate training and development to ensure that personnel are prepared to effectively implement and maintain integrated processes.
• Design and Implementation of Integrated Processes: Once the goals are established and the personnel is trained, it’s time to design and implement the integrated processes. This may involve reviewing and updating existing procedures, as well as identifying opportunities to enhance efficiency and quality.
• Monitoring and Continuous Improvement: After the integrated processes are implemented, it’s crucial to regularly monitor their performance and take action to address any deviations or non-conformities. Continuous improvement is a core principle of both Six Sigma and ISO 9001 and should be a constant focus throughout the organization.

Conclusion

The integration of Six Sigma and ISO 9001 offers a powerful approach to drive excellence in quality and operational efficiency within organizations, aiming to achieve exceptional levels of quality and operational efficiency, resulting in enhanced competitiveness and success in the market. By adopting a systematic and continuous improvement-focused approach, organizations can maximize the benefits of this integration and maintain a long-term competitive advantage.

References

1. ISO (2015). ISO 9000:2015 Standard. Quality Management Systems. Fundamentals and vocabulary.
2. Pande, P., Neuman, R., Cavanagh, R. (2012). The Six Sigma Way: How GE, Motorola, and Other Top Companies are Honing Their Performance. McGraw-Hill Education.
3. The Council for Six Sigma Certification (2018). Six Sigma Yellow Belt Certification. Training Manual. Harmony Living LLC. Buffalo, USA.