Understanding ISO 13485 Certification in the Medical Industry

ISO 13485 certification is the most popular international standard for quality management in the medical device business. An efficient way to satisfy the extensive requirements for a Quality Management System (QMS) in the medical device industry is to implement the ISO 13485 certification standard, which was released by the International Organization for Standardization (ISO). The top ISO standard for medical devices, ISO 13485, is explained in more detail here.

Manufacturers can address the EU Medical Device Regulation (MDR) and other laws and show their dedication to the safety and quality of medical devices by implementing ISO 13485 certification.

Documentation development, including the Quality Policy, Quality Objectives, and Quality Manual, must begin with management support and customer requirements for the QMS. These collectively specify the Quality Management System’s overall implementation and scope. In addition to this, you will also need to develop the additional and required processes and procedures that your company needs in order to correctly develop and deliver your product or service.

See the article List of Mandatory Documents Required by ISO 13485:2016 for a clear explanation of this. An annual survey of certifications to its management system standards is carried out by the ISO organization.

The number of certifications issued by certification bodies recognized by International Accreditation Forum (IAF) members is counted by the ISO survey. Internationally, there were 27,229 valid ISO 13485 certifications in 2021 compared to 25,656 in 2020. Information is derived from the ISO Survey of 2021.

Why Does ISO 13485 Certification Matter?

For producers of medical devices, ISO 13485 certification is crucial since it offers a framework for guaranteeing that their goods continuously satisfy customer and regulatory criteria. Adherence to this standard indicates a business’s dedication to creating medical devices that are both safe and efficient. Additionally, it assists businesses in fulfilling regulatory obligations in numerous global marketplaces. The design, development, and manufacturing of medical devices carry risks that ISO 13485 certification can assist businesses in identifying and reducing. Lastly, it can assist businesses boost productivity and enhance their procedures, which will result in better goods and happier customers.

Which Version of ISO 13485 Certification is in Effect Right Now?

March 2016 saw the most recent update to ISO 13485 certification for ISO medical devices. A focus on risk, a clarification of management and training responsibilities, an improvement to facility requirements, a better alignment of design and development requirements with numerous regulations, a greater emphasis on supplier control, requirements for traceability procedures, the addition of complaint handling, and an improvement in product cleanliness requirements are some of the additions to this update. View all of the modifications here: Infographic: Highlights of the 2016 ISO 13485 Revision.

The ISO 9001:2008 version of ISO 9001 is compatible with the ISO 13485:2016 certification standard. Published by ISO (the International Organization for Standardization), ISO 9001 is a widely accepted standard for Quality Management Systems (QMS). Its specifications are accepted as a legitimate foundation for a QMS’s implementation worldwide. Despite being released subsequent to the significant modification of ISO 9001:2015, the ISO 13485:2016 certification standard is incompatible with the most recent iteration of ISO 9001. Rather, the latest revisions to ISO 9001:2015 were found to be unnecessary for medical equipment.