Nucleus Biologics is proud to announce that it has obtained ISO 13485:2016 certification for the manufacture and distribution of media for the cell and gene therapy industry.
The company is one of the few small lot custom media suppliers for the cell and gene therapy industry to achieve International Organization for Standardization (ISO) certification. Certification was obtained through the British Standards Institute (BSI), one of the oldest and largest independent and internationally recognized standards institutions.
What is ISO certification?
ISO 13485:2016 certification applies to the quality management system governing medical devices and their components. In practice, it means that stringent quality and safety regulations are applied to every step of a product’s life cycle- including design, manufacturing, installation, service, and delivery. Because ISO is an internationally agreed upon set of standards, certification assures conformity to quality standards despite differing national or regional regulatory requirements.
The ISO itself does not carry out certification; rather, it verifies that all essential quality standards have been met. ISO standards are reviewed and updated every five years to ensure that they are current with the state of the technology being certified. Changes in technology may require updated risk management, for example, to adhere to expectations.
Once certified, companies will need to maintain their certification by ensuring employees are fully trained in the quality management system (QMS), and by performing regular internal audits to screen for any non-conformance with regulations and take corrective action. The quality management team should also attend annual or biannual trainings to be sure their practices are up to date.
Why is ISO certification important?
The primary goal of ISO 13485:2016 certification is to demonstrate compliance to laws and regulations of the medical device industry. However, certification offers much more than that. Maintaining high standards of quality oversight benefits the company in several ways. Processes are developed, documented, and constantly reviewed for improvement. Instrumentation and manufacturing processes become more efficient, resulting in labor and cost savings. Any problems that arise can be detected more quickly, and remedied. Since coordination is necessary to implement a QMS, communication between departments generally improves. Employees often feel more vested in a company with transparent procedures and expectations. It is also in the company’s best interest to ensure that all employees are trained well, and that training is kept up to date.
There are also substantial benefits for customers. ISO certification is essentially a commitment to customer satisfaction. It is proof of strict adherence to quality guidelines that are both thorough and effective, as well as consistent adherence to government regulatory requirements. To the customer, it represents a minimized risk of faulty products or uneven product performance, and an expectation of consistent high quality compared to products from uncertified companies. This expectation is strong enough that many customers consider ISO certification non-negotiable when sourcing products – to ensure their products have the smoothest path to commercialization.
The outcome for companies that obtain certification is that they can expect to expand into a wider customer market and/or a market closer to gaining commercial approval for their biomedical products, and therefore more mindful of regulatory expectations.
The path to ISO certification
With ISO compliance delivering so many benefits, it may seem surprising that not all companies pursue certification. Part of the reason for this is that the path to certification is both labor intensive and time consuming- it has taken Nucleus Biologics close to a year to complete the steps necessary for certification.
Companies working toward certification must develop a QMS pertinent to the industry and specific technology being addressed. That means acquiring detailed knowledge of core manufacturing and development processes, receiving expert input about those processes, and then determining where changes might be made to improve safety, efficiency, and accountability. At this point, any new processes that are needed are also created. This is referred to as a gap analysis. At Nucleus Biologics, an external auditor was hired to perform the gap assessment. Their role was to identify key focal points for optimization and to determine which clauses of the international standard were relevant to each process. When the new QMS was ready, detailed plans were created and documented for all processes and procedures that would be covered under ISO certification.
The next step is to actually implement the new QMS and monitor its effectiveness. Each individual process is compared to the requirements stated in the ISO 13485:2016 standard. Once the company is satisfied with their new QMS, it is necessary to choose an accredited external certification body, in this case BSI, to carry out the pertinent certification audits. Once the auditors have concluded that your QMS meets all of the necessary requirements, your organization will be able to be certified.
The rigorous process for ISO certification can represent years of hard work and dedication. Nucleus Biologics is proud to have achieved this goal and remains committed to delivering safe and reliable high-quality products.
- Popular Standards: ISO 13485 Medical Devices. Accessed Aug 2022.