Do I need ISO 9001 if I have ISO 13485 ?

ISO 45001 is an international standard specifically designed to address occupational health and safety (OH&S) management systems. It is focused on hazard identification, risk assessment, and defining controls and procedures to mitigate occupational risks. ISO 45001 is an extension of ISO 13485, which is a standard for safety-critical systems.

ISO 9001, on the other hand, is a broader quality management system (QMS) standard that outlines criteria for meeting customer requirements and enhancing overall customer satisfaction. It encompasses various aspects of an organization's operations and aims to ensure consistent product or service delivery, continuous improvement, and customer focus.

The relationship between ISO 45001 and ISO 9001 is complex and depends on the specific context of the organization. While ISO 45001 focuses on OH&S management, ISO 9001 addresses overall quality management systems. In some cases, ISO 45001 can replace ISO 9001, while in other cases, they may complement each other.

It is important to note that ISO 45001 is not a direct replacement for ISO 900However, ISO 9001 can be used as a reference for the development and implementation of ISO 4500ISO 45001 has its own set of criteria and requirements that organizations must meet to be certified.

ISO 45001 provides a framework for organizations to identify and mitigate occupational risks, which aligns with the purpose of ISO 1348It also focuses on the prevention of workplace injuries and illnesses, which is consistent with the goal of ISO 45001.

In conclusion, ISO 45001 is a valuable standard for organizations to address OH&S management, but it should not be used as a replacement for ISO 900Both standards provide a framework for organizations to ensure quality, safety, and customer satisfaction, but they have different criteria and requirements. It is important for organizations to assess their specific needs and determine whether ISO 45001 meets their requirements for occupational health and safety management.