In this blog post I would like to highlight two ISO (International Organization for Standardization) norms that could create a framework for ensuring the quality and usability of eHealth applications. Quality control is not just a regulatory requirement; it is crucial for enhancing user satisfaction and achieving positive health outcomes. By examining the principles outlined in ISO 9241-210 and ISO 9001, I will explore how these standards can help create applications that are not only functional but also user-friendly and effective.
ISO 9001
ISO 9001 is an international standard that specifies requirements for a quality management system (QMS). It is part of the ISO 9000 family of standards, which focus on various aspects of quality management. Here are some key points about ISO 9001:
- Quality Management System (QMS): ISO 9001 provides a framework for organizations to establish a QMS that ensures consistent quality in products and services.
- Customer Focus: One of the main principles of ISO 9001 is a strong focus on customer satisfaction. Organizations are encouraged to understand customer needs and strive to meet or exceed those expectations.
- Process Approach: The standard emphasizes the importance of managing interrelated processes to achieve desired outcomes efficiently. Organizations are encouraged to identify, manage, and improve their processes.
- Continuous Improvement: ISO 9001 promotes a culture of continuous improvement within organizations, encouraging them to regularly evaluate and enhance their practices to increase efficiency and effectiveness.
- Evidence-Based Decision Making: The standard encourages organizations to rely on data and analysis to support decision-making processes, ensuring that actions are based on objective evidence.
- Risk Management: ISO 9001 incorporates a risk-based thinking approach, helping organizations identify and address potential risks that could affect the quality of products and services.
- Certification: Organizations can seek certification to ISO 9001 through accredited certification bodies. Having this certification demonstrates a commitment to quality management and can enhance credibility with customers and stakeholders.
ISO 9001 is applicable to organizations of all sizes and sectors, making it a widely recognized standard for quality management worldwide.
ISO 9241-210
ISO 9241-210, titled “Ergonomics of human-system interaction — Part 210: Human-centered design for interactive systems,” is an international standard that provides guidelines for human-centered design (HCD) processes for interactive systems. This standard is part of the broader ISO 9241 series, which focuses on ergonomics and usability in human-system interactions. Here are some key aspects of ISO 9241-210:
- Human-Centered Design Principles: ISO 9241-210 emphasizes the importance of placing the user at the center of the design process. It aims to ensure that the needs, preferences, and limitations of users are considered throughout the development lifecycle.
- Design Process: The standard outlines a structured design process consisting of several essential activities:
- Understanding and specifying the context of use: Identifying users, their tasks, and the environments in which the system will be used.
- Specifying user and organizational requirements: Gathering and documenting user needs and preferences to inform the design.
- Producing design solutions: Creating designs and prototypes that address the identified requirements.
- Evaluating design solutions: Testing and assessing the usability of the design with real users to gather feedback and make improvements.
- Iterative Approach: ISO 9241-210 promotes an iterative design process, where designs are continuously refined based on user feedback and evaluation results. This helps ensure that the final product effectively meets user needs.
- User Involvement: The standard encourages active user involvement throughout the design process. Engaging users helps designers understand their experiences and preferences, leading to more effective design solutions.
- Multidisciplinary Collaboration: ISO 9241-210 acknowledges that successful human-centered design often requires collaboration among various stakeholders, including designers, developers, users, and subject matter experts.
- Documentation and Communication: The standard emphasizes the importance of documenting the design process, decisions made, and user feedback. Clear communication among team members and stakeholders is essential for successful design outcomes.
- Applicability: ISO 9241-210 is applicable to a wide range of interactive systems, including software applications, websites, and hardware interfaces, making it relevant for various industries.
In summary, both ISO 9241-210 and ISO 9001 provide valuable frameworks for enhancing the quality of eHealth solutions, but they focus on different aspects of quality assurance. ISO 9241-210 centers on human-centered design principles, emphasizing usability and user experience in interactive systems. In contrast, ISO 9001 is broader in scope, focusing on quality management systems and organizational processes to ensure consistent quality in products and services. By integrating the insights from both standard into developing eHealth solutions it could be ensured that the applications truly serve the needs of their users, ultimately leading to improved health outcomes and greater user satisfaction.
