September 21, 2023
As a medical device provider, Avante Animal Health understands the critical importance of ensuring the safety, effectiveness, and reliability of our products. That is why we continuously invest in our quality management system, which is certified according to the internationally recognized and rigorous ISO 13485:2016 standards. In this article, we will discuss what the ISO certification means to Avante and our customers, and how our dedication to continuous improvement and best practices allows our customers to focus on what matters most: patient care.
ISO 13485 is a globally recognized standard that outlines the requirements for a quality management system specific to medical device manufacturers and service providers. This certification provides assurance that a company has implemented the necessary processes and controls to guarantee the security, efficiency, and dependability of the medical devices and services offered. Unlike other ISO standards, ISO 13485 places a greater emphasis on risk management, regulatory compliance, and customer satisfaction. Obtaining ISO 13485 certification benefits medical device manufacturers and service providers by providing a framework for constant advancement and ensuring their products and services meet industry and customer standards for quality and safety.
Putting the patient first drives our dedication to providing safe, functional, and reliable medical devices that meet customer and regulatory requirements. ISO 13485 is an unbiased standard that impacts our internal processes and how we operate as a company in fulfilling this commitment. It engages our employees to ensure they have a clear understanding of their roles and responsibilities, and it provides a framework for ongoing evidence-based enhancements. Our technicians, field service engineers, and office staff all contribute to our dedication to quality. Through regular training, audits, customer surveys, and internal reviews, we maintain and improve the efficacy of our processes.
ISO 13485 certification provides significant benefits to our customers. Given the impact of medical devices on patients’ lives, it provides peace of mind that Avante’s goals are aligned to the need for reliability in the quality and safety of our products and services. Customer satisfaction is also a core principle of ISO 13485 that is continually and systematically measured. Understanding customers’ needs drives our culture of constant advancement by ensuring that the medical device performs as expected in delivering patient care and meets their requirements throughout its life-cycle.
In addition to ISO 13485:2016 certification, Avante Health Solutions also recognizes the importance of meeting the standards set by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). JCAHO is an independent, non-profit organization that evaluates and accredits healthcare organizations in the United States.
Both ISO 13485 and JCAHO standards are designed to ensure that patients receive the highest quality of care possible. The Joint Commission requires hospitals to verify that its doctors, nurses, and other staff are qualified and competent, while ISO 13485 requires that we document how all levels of employees are trained and deemed competent to perform their job duties. Additionally, we must also establish and maintain a supplier approval process to ensure that Avante’s quality standards are being met throughout the supply chain.
JCAHO and ISO 13485 both have requirements for data collection, analysis of performance, and validation of production processes utilized for continuous improvement. By implementing and maintaining the high standards of ISO 13485, Avante Health Solutions plays an important role in helping healthcare organizations provide better care to patients while meeting the JCAHO regulatory and accreditation requirements.
Our ISO 13485:2016 certification is a testament to our unwavering commitment to quality and leadership in the medical device industry. Through our quality processes established under the ISO 13485 standards, customers can use our products and services with confidence in their dependability, safety, and effectiveness when delivering patient care. We are proud to include the best industry and technical experts on our team and will remain steadfast in our commitment to quality management system as we continue to evolve and innovate.