G&H
G&H achieve ISO 13485:2016 certification.
G&H | ITL (G&H) has been awarded the ISO 13485:2016 certification for its Rochester, New York facility. To achieve this quality management certification, the new life sciences site had to undergo a comprehensive evaluation. The award expands the pre-existing ISO certification of G&H | ITL quality management system in the United Kingdom for medical device production, showing the company’s commitment to high standards.
“The present certification for our Rochester facility represents the natural next step in our continuous development for life sciences,” said Steve Rowland, Quality Assurance & Regulatory Affairs Manager at G&H | ITL. “One can notice the surge in healthcare interest from past years, driven by a general health awareness of the global population. As such, G&H had to respond – not only by investing into this state-of-the-art life sciences innovation hub that we are putting on its feet in Rochester, New York but also through an avenue that officially certifies our activity.”
Rowland concluded, “That is why we chose to add G&H | ITL (US) to our ISO 13485:2016 certification process. G&H’s commitment towards sustainable, cutting-edge MedTech design and manufacturing can now be seen through this achievement, next to the vetted quality of our devices that our clients are fully benefitting from.”
The evaluation process started in August 2023, at the time experts compiled a list of improvement recommendations needed to achieve the certification. As a result of this process, G&H’s actual certification timeline only lasted four months.
About ISO 13485:2016 certification
According to the International Organisation for Standardisation’s website:
“ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organisations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organisations.”