Harmonising Process Improvement with Technical Competence: A Deep Dive into Quality Standards

Understanding the Relationship Between ISO 18404:2015 and ISO/IEC 17025

In the world of quality management and continuous improvement, ISO standards play a pivotal role in ensuring that organisations adhere to internationally recognised best practices. Two such standards that often come into focus are ISO 18404:2015 and ISO/IEC 17025. While they serve different primary purposes, understanding their relationship can provide valuable insights into the broader landscape of quality assurance and operational excellence.

ISO 18404:2015 - Lean and Six Sigma Competencies

ISO 18404:2015 is a unique standard that provides a clear framework for the required competencies in both Lean and Six Sigma methodologies. It serves as a benchmark for organisations and individuals aiming to achieve or demonstrate proficiency in these areas.

Here's a more detailed breakdown:

For Individuals:

The standard outlines the skills and knowledge expected of Lean practitioners. This includes understanding Lean principles, tools, and techniques, as well as the ability to apply them in various contexts. For Six Sigma, the standard defines the competencies for different belt levels - Green and Black. Each level has a specific set of skills and knowledge areas, ranging from basic statistical tools for Green Belts to advanced problem-solving and project management skills for Black Belts.

For Organisations:

This standard offers a comprehensive framework to gauge an organisation's commitment to quality and efficiency. For those embracing Lean, it assesses the depth of embedded Lean principles, highlighting continuous improvement, waste reduction, and customer-centricity. Simultaneously, for entities adopting Six Sigma, the standard scrutinises the maturity of their Six Sigma initiatives, emphasising their prowess in project identification, prioritisation, portfolio management, and the realisation of tangible improvements.

Training and Certification:

The standard emphasises the importance of appropriate training and certification for individuals. It provides guidelines for training programs, ensuring that they cover the necessary competencies and are delivered effectively. Organisations are also encouraged to ensure that their Lean and Six Sigma practitioners undergo regular refresher training and stay updated with the latest tools and techniques.

Continuous Improvement:

ISO 18404:2015 is not just about achieving a certain level of competency; it's about continuous improvement. Both individuals and organizations are encouraged to regularly review and enhance their Lean and Six Sigma practices, ensuring they remain relevant and effective.

ISO/IEC 17025 - Testing and Calibration Laboratories

ISO/IEC 17025 is a globally recognized standard that sets out the specific requirements for the competence of testing and calibration laboratories. Its primary goal is to ensure that labs produce accurate, consistent, and valid results. Here's a more detailed exploration:

Scope and Application:

ISO/IEC 17025 is applicable to all organisations conducting laboratory activities, regardless of the number of personnel or the scope of testing and calibration activities. It covers both testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

Management Requirements:

The standard emphasises the importance of quality management systems for laboratories. This includes document control, non-conformity management, corrective actions, and preventive actions. It also covers areas like organisational structure, personnel responsibilities, and service to the customer.

Technical Requirements:

Laboratories must ensure that they have the necessary resources to produce valid results. This includes suitable equipment, trained personnel, and proper environmental conditions. The standard also addresses factors like method validation, equipment calibration, and quality assurance of results.

Results Assurance:

ISO/IEC 17025 requires labs to participate in proficiency testing or other inter-laboratory comparisons to ensure the validity of their results. Laboratories must also have a system in place for handling and assessing the uncertainty of measurement for each measurement procedure.

Continuous Improvement:

The standard promotes a culture of continuous improvement. Laboratories are encouraged to regularly review and refine their processes, ensuring they remain effective and up-to-date with industry best practices.

Impartiality and Confidentiality:

ISO/IEC 17025 places a strong emphasis on the impartiality of laboratory activities. Labs must ensure that their activities are not influenced by external pressures or conflicts of interest. Confidentiality of customer data and results is also a key component of the standard, ensuring trust and integrity in laboratory operations.

The Relationship Between ISO 18404:2015 and ISO/IEC 17025

While ISO 18404:2015 and ISO/IEC 17025 cater to different primary objectives, their synergistic relationship can be a powerful tool for organisations aiming for comprehensive quality assurance and operational excellence. Here's a more detailed exploration of their interplay:

Unified Approach to Quality:

Both standards emphasise a commitment to quality, albeit from different angles. While ISO 18404:2015 focuses on process improvement and waste reduction through Lean and Six Sigma methodologies, ISO/IEC 17025 ensures the technical competence and validity of results in testing and calibration laboratories. Together, they provide a holistic approach to quality assurance, from process optimisation to result validation.

Data-Driven Excellence:

ISO 18404:2015's emphasis on data-driven decision-making complements ISO/IEC 17025's focus on producing valid and reliable data. Laboratories adhering to ISO/IEC 17025 can provide the accurate data needed for Lean and Six Sigma projects, ensuring that improvements are based on sound evidence.

Continuous Improvement in Laboratories:

Laboratories governed by ISO/IEC 17025 can benefit immensely from the continuous improvement principles of ISO 18404:2015. Implementing Lean and Six Sigma methodologies can lead to streamlined lab processes, reduced turnaround times, and enhanced efficiency, ensuring that labs not only produce accurate results but also operate at peak efficiency.

Enhancing Competence and Training:

The training and competency requirements of ISO 18404:2015 can be integrated into laboratories to further enhance the competence emphasised by ISO/IEC 17025. This ensures that laboratory personnel are not only technically competent but also skilled in Lean and Six Sigma methodologies, leading to a more holistic approach to problem-solving and process improvement.

Customer-Centric Focus:

Both standards, in their essence, prioritise the end customer. ISO 18404:2015 emphasises meeting customer needs through waste reduction and value addition, while ISO/IEC 17025 ensures that customers receive valid and reliable test or calibration results. This shared focus ensures that organizations can meet and exceed customer expectations consistently.

VA Innovation Final Thoughts...Customer-Centric Excellence

The relationship between ISO 18404:2015 and ISO/IEC 17025 is a testament to the power of integrating different quality standards for comprehensive organisational excellence. By understanding and leveraging the strengths of both standards and understanding how they link together, organisations can achieve a level of quality assurance and operational efficiency that is greater than the sum of its parts and capitalise on their USP.