Benefits of using ISO 13485 Quality Management System

Benefits of Using ISO 13485 Quality Management System (QMS)

ISO 13485 is a quality management standard specifically designed for the medical device industry. It provides a set of requirements for a quality management system (QMS) that organisations can use to demonstrate their ability to design and manufacture medical devices that meet customer and regulatory requirements.

Medical device manufacturers that want to distribute their products in the European Union (EU) are required to comply with the EU IVDR 2017/746 or EU MDR 2017/745 regulations to ensure that their products are safe and effective. Implementing QMS based on the ISO 13485 standard allows the manufacturer to comply with European regulations.

 

There are several benefits to using ISO 13485 QMS:

  • Improved quality and safety: By following the requirements of ISO 13485, organisations can ensure that their products are designed and manufactured to the highest quality standards. A QMS based on ISO 13485 includes product development, design, and validation requirements. This can reduce the risk of defects or failures and improve patient safety and product quality.
  • Enhanced customer satisfaction: By consistently meeting the requirements of ISO 13485, organisations can demonstrate to their customers that they are committed to quality and are able to consistently deliver high-quality products. A QMS that is based on ISO 13485 includes requirements for customer feedback and complaint handling. This can help to enhance customer satisfaction, improve customer service and increase loyalty.
  • Increased efficiency and effectiveness: A QMS based on ISO 13485 includes requirements for process control and continuous improvement. By implementing a quality management system based on ISO 13485, organisations adopt a process that addresses problems quickly. Implementing these requirements can help manufacturers to improve internal processes, increase efficiency and reduce costs.
  • Increased competitiveness: Through certified compliance with ISO 13485, organisations can demonstrate their commitment to quality to potential customers, regulators and the wider industry and differentiate themselves from their competitors. This can help to increase their competitiveness in the market.
  • Enhanced regulatory compliance: ISO 13485 is harmonised with EU IVDR 2017/746 and EU MDR 2017/745 and is recognised by regulatory authorities worldwide. Compliance with the standard can help organisations meet regulatory requirements for the design and manufacture of medical devices. This can simplify the process of obtaining regulatory approvals and help organisations access new markets.
  • Improved risk management: Following the requirements of ISO 13485, organisations can identify and evaluate potential risks associated with their medical devices and implement controls to mitigate those risks. This can help to protect patients, users and other stakeholders. ISO 13485 references ISO 14971 to further define the requirements and application of risk management activities for medical devices.
  • Increased transparency and accountability: By implementing a quality management system based on ISO 13485, organisations can provide evidence of their commitment to quality and demonstrate their ability to deliver high-quality products consistently. Implementing a QMS based on ISO 13485 can give medical device manufacturers a competitive advantage by demonstrating their commitment to quality and compliance with regulations. This can increase transparency and accountability and help to build trust with stakeholders.

 

Implementing a QMS based on ISO 13485 ensures that the company complies with regulatory requirements, such as EU IVDR 2017/746 and EU MDR 2017/745, allows them to access new markets, improves risk management and product quality, and increases transparency and accountability of the company. Overall, the benefits of using ISO 13485 make it an essential standard for any organisation in the medical device industry looking to consistently deliver high-quality products and demonstrate their commitment to quality.

In conclusion, ISO 13485 is a valuable quality management standard that offers numerous benefits to organisations in the medical device industry. By implementing a quality management system based on ISO 13485, the manufacturer can improve the quality and safety of their medical devices, enhance customer satisfaction, increase efficiency and effectiveness, and increase their competitiveness in the market.

LFH Regulatory have expert consultants that can help you implement and maintain your Quality Management System. Contact us today to see how we can help.

References:

ISO 13485:2016 Medical devices – Quality management system – Requirements for regulatory purposes

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, Article 10

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 10

Written by Paulina Rolecka, Regulatory Affairs and Quality Assurance Consultant at LFH Regulatory Ltd.

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