The importance of the ISO 9001 standard in the healthcare industry

In the digital age, the healthcare sector is facing increasing pressure to reduce costs and increase efficiency. To achieve this, organizations seek certification that demonstrates their ability to deliver products and services in a reliable and consistent manner. They have recognized that complying with these standards also has benefits that go beyond helping them meet objectives and seek savings opportunities. Implementing a quality management system not only helps them to comply with those standards, but it also gives them an idea of how they can improve and eliminate any bottlenecks or inefficiency in their operations.

With so many certification options available, it's important to choose the right one for your organization's needs and resources. One of the most adopted certifications is ISO 9001, which stands for standard number 9001 of the International Organization for Standardization (or “quality”). Let's take a closer look at why this certification is so beneficial if you work in the healthcare sector

What is ISO 9001?

ISO 9001 is the most adopted international standard for quality management systems and business management. The standard is divided into a series of clauses, each of which has a specific purpose, description and method of application. There are currently five recognized versions of the standard. The most recent version was released in 2018. Why is it important? Organizations that have implemented a quality management system and are in the process of applying for certification are required to follow the version that was in force at the time of its implementation. The following clause is just one example of how the standard can be applied to the healthcare sector. It serves as a useful starting point to better understand the general benefits of this certification, as well as its limitations.

Why is ISO certification beneficial?

Organizations certified according to ISO 9001 have demonstrated that they have the organizational structure, resources and management systems necessary to offer products and services in a coherent manner and in accordance with customer expectations. Obtaining this certification transmits to current and potential customers the message that their organization takes quality seriously and that it has the right tools to identify potential risks and problems, and to correct them before they become such. ISO certification also provides benefits beyond customer satisfaction. By implementing a certified quality management system, organizations can benefit from greater efficiency and reduced waste, as well as increased employee engagement and a better working environment.

What does ISO 9001 certification mean for the healthcare sector?

Healthcare organizations are required to comply with many different standards, including environmental and safety regulations. ISO 9001 certification means that an organization has implemented a certified quality management system and has been audited to ensure that it meets that standard. Organizations that meet the requirements of ISO 9001 certification must implement a documented quality management system that is regularly evaluated and verified by an independent third party. The certification is valid for a period of three years. Organizations must renew their certification by undergoing a reevaluation process every three years.

Limitations of the ISO 9001 standard

ISO 9001 certification does not take into account the specific needs of different sectors, such as the healthcare industry. While it helps organizations to establish best practices and eliminate inefficiencies, it also requires a significant investment of time and resources. In addition, it does not allow us to know the processes that initiate customer orders or the customer experience as a whole. Organizations that implement ISO 9001 certification must also be willing to make changes when necessary. The certification process is regularly audited by an independent third party and organizations must be willing to make whatever changes are necessary to meet certification requirements.

Key Conclusion

ISO 9001 certification is a widely accepted standard that helps organizations maintain consistency and achieve customer satisfaction through quality products and services. Although it is beneficial for a wide range of sectors, including healthcare, it requires significant investment and does not take into account the specific needs of the healthcare sector.