What is ISO 13485 Certification?

ISO 13485 is an internationally recognized quality management standard specifically for the medical device industry. It outlines a comprehensive quality management system that helps organizations design and manufacture safe and effective medical devices. Certification to ISO 13485 is a validation that a company has implemented the standard successfully and is committed to continual improvement.

The Duration of Getting ISO 13485 Certified

The duration of getting ISO 13485 certified can vary depending on the size and complexity of your organization as well as how prepared you are for the assessment. Generally, it takes 3-12 months to get certified. The duration can get affected by various factors such as:

The size of the organization

The size of the organization is one of the primary factors that can affect the duration of getting ISO 13485 certified. Generally speaking, larger organizations will take longer to certify than smaller organizations. This is due to the fact that larger organizations typically have more complex systems and procedures in place, which can take longer to assess.

The complexity of the organization

Another factor that can affect the duration of getting ISO 13485 certified is the complexity of the organization. Organizations that have more complex systems and procedures in place will typically take longer to certify than those with simpler systems. This is because it can take longer to assess all of the different aspects of a complex organization.

The experience of the certification body

The experience of the certification body is another factor that can affect the duration of getting ISO 13485 certified. Certification bodies that have experience certifying similar organizations will typically be able to do so more quickly than those without such experience. This is because they will already be familiar with the types of systems and procedures that are typically in place in these types of organizations.

The number of employees

The number of employees is another factor that can affect the duration of getting ISO 13485 certified. Organizations with more employees will typically take longer to certify than those with fewer employees. This is because there will be more people who need to be trained on the requirements of the standard and on the certification process itself. 

The location of the organization

The location of the organization is another factor that can affect the duration of getting ISO 13485 certification. Organizations that are located in countries with well-developed infrastructure and regulatory systems will typically be able to certify more quickly than those located in less developed countries. This is because it can take longer to assess all of the different aspects of a less developed country's infrastructure and regulatory system.

Conclusion

The duration of getting ISO 13485 certification can vary depending on the size and complexity of your organization as well as how prepared you are for the assessment. Generally, it takes 3-12 months to get certified. The duration can get affected by various factors such as the size of the organization, the complexity of the organization, the experience of the certification body, the number of employees, and the location of the organization.