In the field of biotechnology and medical device manufacturing, compliance with international standards is a milestone of competence and reliability. Recently, Hygia Bio achieved a significant milestone by obtaining ISO 13485 certification, demonstrating its adherence to global standards of quality and safety. This article outlines the significance of this certification, providing a detailed insight into what ISO 13485 certification entails and why it is crucial for Hygia Bio and the industry as a whole.
What is ISO 13485?
ISO 13485 certification is an internationally recognized seal of approval that highlights that a company adheres to strict standards to ensure that its medical products are of high quality and safe for use. When you are purchasing a medical device, such as a thermometer or a blood pressure monitor, it is natural to want to ensure that they will work correctly and provide accurate readings. ISO 13485 serves to provide that confidence. This certification is globally recognized. So, a company that follows this standard is aligned with what is considered best practice on a global scale.
One unique aspect of this standard is that it looks at the complete product lifecycle, not just the final product. This means it examines the entire journey the product takes from the initial idea to reaching the customer, including how it is designed, how it is manufactured, how it is sold, and how it is used.
ISO 13485 incorporates a model known as PDCA (Plan-Do-Check-Act). This is a method used for continuous quality improvement. Using this model, ISO 13485 helps companies to continuously improve and ensure that their medical devices are of the highest quality. The standard requires companies to keep records of everything they do, providing robust traceability and documentation. At its core, ISO 13485 is a rigorous and well-thought-out way to ensure that medical devices are safe, effective, and of the highest quality, which is crucial when people’s health and lives are at stake.
What does it mean for a company to have ISO 13485 certification?
Having an ISO certificate, such as ISO 13485, means that a company adheres to internationally recognized quality management standards. These standards are designed to ensure that the company’s products and services are safe, reliable, and of good quality, while also meeting industry-specific regulations and requirements. Here are some key points about what it means to have an ISO certification:
Assured Quality: Certification indicates that the company follows a rigorous and standardized quality management system, which, in turn, means that the products or services it offers are of high quality.
Regulatory Compliance: ISO certification helps ensure that the company complies with applicable laws and regulations. This is especially critical in highly regulated sectors such as the medical device industry.
Continuous Improvement: ISO standards encourage continuous improvement through regular assessments and audits of the quality management system, helping the company identify areas for improvement and implement them.
Trust and Credibility: Having an ISO certification increases the confidence of customers, suppliers, and stakeholders in the company, as it demonstrates a commitment to quality and compliance.
Risk Reduction: By following ISO-recommended practices, companies can identify and mitigate risks in their operational processes, resulting in fewer errors, rework, and product returns.
Transparency and Traceability: ISO standards promote transparency in business processes and help establish traceability systems that are crucial for quality management.
What is the importance of ISO 13485 certification?
ISO 13485 certification is a powerful statement of a company’s quality and safety of medical devices. It is more than just a certificate; it is a demonstration of a company’s serious commitment to quality. This standardized framework is vital to ensure consistency in delivering products and services that not only meet but often exceed customer expectations and regulatory requirements.
Risk management is a central feature of ISO 13485. The standard requires companies to identify and manage risks throughout the entire lifecycle of the medical device, from design to delivery. In an industry where errors can have serious consequences, effective risk management is crucial.
How does the Certification Process Work?
The ISO 13485 certification process is rigorous and requires a detailed assessment conducted by an independent and accredited certification body. It involves document review, on-site audits, and ongoing assessments to ensure the maintenance of quality standards. This process ensures that the company has a robust Quality Management System that can consistently deliver safe and effective medical devices.
What are the Differentiators and Benefits?
Obtaining ISO 13485 certification provides several benefits, including some of the following:
Expanded Access to Global Markets: Facilitates entry into markets with international quality standards.
Continuous Improvement: Promotes a culture of regular review and continuous improvement of processes.
Enhanced Efficiency: Helps identify areas for improvement, optimizing operational efficiency.
Trust and Credibility: Reinforces stakeholder confidence in the quality and safety of produced medical devices.
Supplier Monitoring: Expands the ability to monitor and evaluate supplier performance.
Comparison with Other Certifications
ISO 13485 originated from ISO 9001, which is a set of rules aimed at ensuring the quality of products in various industries, not just in the medical field.
In this sense, in addition to ISO 13485, there are other relevant standards, such as ISO 14971, which deals with the application of risk management to medical devices, and ISO/TR 80002-2:2017, related to software validation for medical device quality systems. Comparatively, while some standards are more generic or focused on specific areas like software or risk management, ISO 13485 offers a comprehensive and practical approach to ensuring the quality and safety of medical devices.
ISO 13485 certification is Hygia Bio’s commitment to excellence, quality, and safety. It represents a significant milestone that not only elevates Hygia Bio’s position on the global stage but also reinforces its reliability in delivering high-quality medical devices. We invite you to explore our diverse range of products and services and to contact us for more information on how we can meet your specific needs in medical devices.
