Understanding ISO 13485 Certification in the Medical Industry

ISO 13485 is the most popular international standard for quality management in the medical device business. Implementing the ISO 13485 certification standard, which the International Organization for Standardization (ISO) released, is an efficient way to satisfy the extensive requirements for a Quality Management System (QMS) in the medical device industry. This explains the top ISO standard for medical devices, ISO 13485, in more detail.

Compliance with Regulations

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

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 to correctly develop and deliver your product or service.

Mandatory Documents

See the article “List of Mandatory Documents Required by ISO 13485:2016” for a clear explanation of this. The ISO organization conducts an annual survey of certifications to its management system standards.

Certification Statistics

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

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 additions to this update. View all the modifications here: Infographic: Highlights of the 2016 ISO 13485 Revision.

The ISO 9001:2008 version of ISO 9001 aligns with the ISO 13485:2016 certification standard. ISO (the International Organization for Standardization) published ISO 9001, a widely accepted standard for Quality Management Systems (QMS). Organizations worldwide accept its specifications as a legitimate foundation for QMS implementation. Even though ISO released the ISO 13485:2016 certification standard after the significant modification of ISO 9001:2015, it remains incompatible with the most recent iteration of ISO 9001. Instead, experts found the latest revisions to ISO 9001:2015 unnecessary for medical equipment.