Overview of ISO 13485
ISO 13485 is a quality management system (QMS) standard designed specifically for the medical device industry. This standard proves that the design and production processes of medical devices have met the requirements to ensure the safety and consistent performance of the product. ISO 13485 was originally developed from ISO 9001, but with several important differences such as increased documentation and a focus on risk management, work environment, and regulatory compliance. The latest version of this standard is ISO 13485:2016, which replaces ISO 13485:2012. In Indonesia, the Good Manufacturing Practices for Medical Devices (CPAKB) guidelines also refer to this standard, aiming to ensure the safety, quality, and benefits of medical devices.
ISO 13485 applies to organizations involved in various stages of the medical device life cycle, including design, production, installation, and related services. In addition, certification bodies and other external parties can also use it for audit processes. This standard ensures complete recording and control of the process, including if some stages are carried out by third parties. ISO 13485 not only helps organizations meet regulations, but also provides clear guidance in maintaining consistent quality of medical products, making it a vital component in the medical device industry.
To obtain ISO 13485 certification, companies must go through a series of processes that include initial assessment, internal team formation, training, and internal audits before submitting to an accredited certification body, such as KAN, UKAS, or ANAB. Although many companies already have ISO 9001, ISO 13485 certification is still needed because it contains specific requirements that are important for the medical device industry. Implementing this standard helps companies adapt to the rapid development of medical technology and ensure that the products produced meet high quality standards.
Benefits of Implementing ISO 13485
ISO 13485 offers a variety of benefits, including:
- Meeting regulatory requirements in the medical device sector.
- Reducing unexpected risks during the process.
- Gaining international recognition through third-party certification.
- Providing a competitive advantage in the global market.
- Facilitating continuous process control and improvement.