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The ISO 13485 Standard for Medical Devices: 5 Important Facts to Know

This article presents the most important facts about the ISO 13485 certification that is a specially designed standard for the quality management of medical devices or equipment.

The ISO 13485 is the globally recognized standard for medical devices or equipment which can be adopted by manufacturers, raw material suppliers, distributors, sellers, services providers, and others in the same field. By achieving the standard, a business can demonstrate that their products have accomplished a higher quality level and can fully meet the needs of customers. Most importantly, achieving the ISO 13485 certification confirms that a business or manufacturer of medical devices complies with all mandatory regulations of the medical industry as well as the legal requirements. Therefore, every business in the medical device sector needs to achieve this ISO standard to attain their quality goals and to make a name in the industry by supplying quality-assured and safe devices and equipment.

If you want to get the certification, you should remember that it is not just a formality. There are intricate procedures including gap analysis, implementation of a strong QMS, and auditing. Furthermore, you need to create proper documentation supporting your quality processes and maintain them. In this article, we put the key concepts about the ISO 13485 certification that you should consider while preparing for it.

5 Key Concepts to Know Before Achieving the ISO 13485 Certification

1. Requirements for the ISO 13485 Standard

An organization in the medical device industry needs to first fully understand the underlined requirements and principles of the standard. To be sure you get certified, you need to define the scope of the QMS (Quality Management System) and conduct a pre-audit/gap analysis of existing quality processes to understand where they fail to comply with the standard. Other requirements that it should follow are the development of documentation, providing employee training, new QMS implementation, internal review, and correction of any non-compliance issues.

Once the QMS is implemented in accordance with these requirements, the organization is awarded the certificate by a certification body.

2. New COVID-19 Protection Requirements in the ISO 13485

The producers, suppliers, distributors, and all other types of medical device organizations now need to consider some specific requirements for preventing any spread or contamination of COVID-19 infection through their devices. It is necessary for organizations to follow these requirements because the devices can not only spread infection when used inappropriately but can themselves get infected during the manufacturing from other sources such as raw materials, filthy parts, infected workers, etc.

Since protection from COVID-19 has been a global concern today and the medical device sector has high-risk exposure, the ISO enforced new requirements especially for PPEs, masks, and equipment manufacturers.

3. External Audit of the ISO 13485

The external audit is conducted by a selected third-party or certification body only after the implementation of the QMS completed in accordance with the ISO 13485 requirements. They have a specific approach and expert individuals (auditors) who would do an on-site audit and investigate the QMS critically to find the non-conformance issues. On completion of the external audit, they will award the certificate if they see that all prerequisites of the standard are met. If there are non-compliances, they would provide time to the organization as well as necessary suggestions to correct them.

4. Major Pitfalls to Avoid

Mistakes are bound to happen since the certification procedure is not as easy as it seems. A medical device manufacturer or organization should plan the procedure consciously and seek help from an external consultancy if needed to avoid any major pitfalls. The most common mistakes that organizations make are avoiding risk-based thinking, failure to conduct management review, lack of traceability, and neglecting the observations of internal audits.

5. Costs for Getting the ISO 13485 Standard

The cost for obtaining the ISO 13485 medical device standard mainly include the costs required by the organization in deploying resources, technologies, and employees for implementing the QMS. It also includes the fees and charges of the certification body. Some minimal extra costs may be required for hiring an external consultant. Clearly, the total costs rely on the size of the organization, complexities and risks in your products, and resources available within the organization.

The ISO 13485 certification is a quality management certification but just for the medical devices. Hence, it comes with many more specific requirements in addition to what is underlined by ISO 9001. No doubt, implementing a QMS and preparing for the certification procedure is challenging for any medical device organization. However, it is also a necessary responsibility of the organizations to get certified to show their products are of the best quality and that they conform to the best practices for manufacturing.