Quality with a Purpose

 

All ISO standards are reviewed and revised regularly to make sure they remain relevant to the marketplace. ISO 13485:2016 responds to the latest QMS practices, reflecting the evolution in medical device technology and changes in regulatory requirements and expectations. Transasia is the first Indian IVD Company to receive the ICMED 13485 quality certificate in 2018 for indigenously manufactured medical devices.

 ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. Designed to be used by organizations throughout the lifecycle of a medical device, from initial conception to production and post-production, it includes final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.

Ensuring process adherence and quality of products

ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.

 The PDCA cycle to ensure continual improvement of QMS

This quality management system also enables an organization to consistently provide safe and effective medical devices and fulfill customer and regulatory requirements. It is also flexible enough to meet the individual needs of different types of medical devices organizations.

Benefits

Safety and performance of medical devices are paramount in this highly regulated industry; this is why quality management systems are a regulatory or legal requirement in many countries. ISO 13485 can help organizations involved in any part of a medical device’s life cycle:

• Demonstrate compliance with regulatory and legal requirements
• Ensure the establishment of QMS practices that consistently yield safe and effective medical device
• Manage risk effectively
• Improve processes and efficiencies as necessary
• Gain a competitive advantage

 Key improvements

The new version of ISO 13485 places greater emphasis on risk management and risk-based decision making for processes outside the realm of product realization. The focus is on risks associated with the safety and performance of medical devices and compliance with regulatory requirements. In addition, the standard asks organizations to be more stringent when it comes to outsourcing processes by putting into place controls, such as written agreements, for assessing their suppliers – again based on risk.

• ISO 13485 also reflects the increased regulatory requirements for organizations across the medical devices supply chain, namely:
• A greater emphasis on appropriate infrastructure, particularly for the production of sterile medical devices, and additional requirements for the validation of sterile barrier properties
• Increased alignment with regulatory requirements and, in particular, regulatory documentation
• More focus on post-market activities, including complaint handling and regulatory reporting
• Broadening of the standard’s application to encompass organizations that interact with the medical devices manufacturer, including those involved in:

o    Design and development or repair and maintenance of medical devices

o    Supply of raw materials, components or subassemblies

o    Performance of services such as contract manufacture, sterilization, logistics or calibration of measurement equipment

o    Import or distribution of medical devices

•  Additional requirements in the design and development of medical devices, taking into consideration their usability, the use of standards, and a more robust planning for the verification, validation, transfer and records maintenance of the design and   development activities
• Harmonization of validation requirements for different software applications, such as QMS software, process control software, software for monitoring and measurement

 In conclusion

By following the PDCA cycle, an organization can focus the processes and objectives of the QMS toward overall improvement, leading to increased efficiency and cost savings that can be put toward further improvement. And that is a win-win for both the organization, and its customers.