What are the 7 quality management principles ?

Title: What are the 7 Quality Management Principles?

Quality management is a critical aspect of business operations, and organizations aim to continuously improve their quality management processes to meet the changing needs of their customers. The scope of BS EN ISO 9864-2021, also known as ISO 9001:2015, covers a wide range of areas, including quality management principles and their application, process approach, management responsibility, and commitment. In this article, we will discuss the 7 quality management principles outlined in BS EN ISO 9864-2021.

Quality Management Principles and their Application

ISO 9001:2015 is based on a set of quality management principles that are customer-focused, leadership committed, engagement of people, process approach, evidence-based decision making, relationship management, and continual improvement. These principles are applied throughout the entire ISO 9001:2015 standard, and they are designed to help organizations achieve and maintain high levels of customer satisfaction and satisfaction.

Scope and Applicability

ISO 9001:2015 is primarily focused on various industries across the globe, including manufacturing, service, and service-based industries. It can be implemented by any organization, regardless of its size or sector. On the other hand, ISO 13485:2016 is specifically designed for medical device manufacturers. It outlines requirements for a comprehensive quality management system within the medical device industry.

Quality Management Principles

ISO 9001:2015 is based on a set of quality management principles, including a customer-focused approach, leadership commitment, engagement of people, process approach, evidence-based decision making, relationship management, and continual improvement. ISO 13485:2016 also incorporates these principles but puts greater emphasis on regulatory compliance, risk management, and traceability in the context of medical devices.

Risk-Based Approach

The ISO 9001:2015 standard also emphasizes the risk-based approach to quality management. It is essential to identify, assess, prioritize, and mitigate risks that may affect the quality management system. This approach is designed to ensure that the organization takes appropriate actions to minimize the impact of potential risks on its quality management system.

Conclusion:

In conclusion, the 7 quality management principles outlined in BS EN ISO 9864-2021 are designed to help organizations achieve and maintain high levels of customer satisfaction and satisfaction. By applying these principles, organizations can continuously improve their quality management processes and meet the changing needs of their customers. It is important to note that ISO 13485:2016 is specifically designed for medical device manufacturers and should be implemented in accordance with the requirements of the relevant regulations and guidelines.