Why does Medical Device Industry Require ISO 13485 & 31000 Certification?

Medical device manufacturing industry requires certain ISO standards to demonstrate their credibility and mitigate the risk factors. This article will discuss two ISO certifications that every business dealing with medical device manufacturing should achieve.

Health is wealth. Therefore, organizations that are somehow related to the healthcare should be aware of their responsibility. International Organization for Standardization has introduced a number of standards to assure the quality of the healthcare services. When it comes to the healthcare, only thought of hospitals pops up in the minds. In reality, there are many organizations that come under this category of healthcare. Healthcare also includes the organizations that manufacture and supply medical device. These organizations play an important role in the healthcare sector. Is it possible for the laboratories, research organizations, and hospitals to determine an accurate report while the medical device itself is faulty? To get the right treatment, it is important to determine the problem. To determine the problem, it is important to perform testing and another necessary medical process. Proper use of these methods can be possible when the used medical equipment is right. Hence, medical device manufacturing and supply industry should take special care of the quality and risk management system.

This article is going to discuss two ISO certifications vital for the medical device industry- ISO 13485 and 31000 Certification.

ISO 13485

ISO 13485 certification lists the quality objectives essential for a quality management system in the medical device industry. This certification contains a set of requirements for a comprehensive quality management system. This standard is designed particularly for the designing and manufacturing of medical devices.

The main objective of this standard is to set up a quality policy for the quality management system. Quality objectives are defined as the methods of translating the business goals into plans for improvement. You can use both customer and regulatory requirements as input for the quality policy. How can the certification benefit you? Let’s check out the benefits of this standard:

• Lowers operational costs
• Reduces the production loss rate
• Establishes your business as a safe manufacturer or supplier of medical devices
• Provides a worldwide accepted management system

ISO 13485 follows an approach introduced in ISO 9001:2000. This approach regards the quality management system as a set of interrelated processes covering the product manufacturing and provision of a service. This process transforms a series of inputs into outputs. Inputs contain everything required to accomplish the transformation. When your organization is compliant with this ISO standard, easily you will be able to establish your credibility in the market. In this way, you will draw the attention of potential stakeholders and customers.

Now, let’s move towards ISO 31000 certification.

ISO 31000

ISO 31000 helps an organization to integrate a risk-based decision-making process into the governance body, planning, management, reporting, policies, values, and culture of that organization. This standard encourages an open and principle-based system that enables an organization to apply the principles in the standard set out by the organization. An organization that manufactures and supplies medical device should follow ISO 3100o guidelines to set successful strategy and governance, foster a good work culture, achieve risk-informed decision-making, adopt the innovation and technological changes, and execute the operations and projects properly. Like ISO 13485 certification, ISO 31000 has a bunch of benefits.

Listed below are key benefits of ISO 31000:

• Increases and protects the value
• Improves the organizational processes
• Makes decision-making easier
• Addresses risks and uncertainty
• Introduces a systematic and well-structured risk-management system
• Establishes the transparency of your organization
• Facilitates continual improvement of your organization

Managers of your organization should understand the importance of risk management. First, a medical device manufacturer and supplier organization should understand that along with ISO 13485 certification, 31000 certification is also important for them. While the first one is specific to the medical device industry, the second one can be adopted by any industry. Medical Device quality management standard can help an organization boost the overall performance of the business by enhancing the quality of the products offered by the organization while the risk management standard can encourage the stakeholders to invest and the customers to purchase the medical devices by mitigating the risk factors.

From the above discussion, it is clear that healthcare needs both ISO 13485 and ISO 31000 standard to improve the overall performance and boost the sales. Hence, if you want to assure the overall development and performance of your medical device manufacturing and supply business, you must consider these two ISO certifications.