Medical device companies are in a very regulated industry where product quality, product safety, and product uniformity are key. By achieving ISO 13485 certification, medical device manufacturers can gain a structured quality management system to help them meet regulatory and customer requirements throughout the medical device lifecycle. It is applicable to organizations engaged in the design, development, production, installation, servicing and other related activities with medical devices.
Getting certified isn’t just about putting the quality procedures into place. Manufacturers should develop a appropriate quality management system, record their manufacturing process, manage risks, carry out internal audit and submit to an independent certification audit to prove their compliance. Certification by a good certification body may be more efficient and help manufacturers to understand the requirements that must be met.
How to obtain ISO 13485 Certification for Medical Device Manufacturers?
Medical device manufacturers are able to get certified by an accredited certification body qualified to evaluate quality management systems according to ISO 13485. The certification body assesses the manufacturer’s processes, documentation, risk management practices, production controls and quality procedures prior to issuing the certificate.
Manufacturers need to be cautious when choosing a certification organization that is accredited, has experience in medical device industry, has geographical coverage, and is knowledgeable about the regulatory landscape. Adopting an experienced provider is especially significant, as medical device companies may have complex requirements regarding product safety, traceability, validation, and regulatory compliance.
What’s ISO 13485 Certification?
ISO 13485 is an internationally accepted standard for quality management systems that is dedicated to organisations dealing with medical devices. It is about keeping the processes consistent to ensure the safety and effectiveness of the medical devices and compliant with the applicable regulatory requirements.
For manufacturers, the certification demonstrates the organization’s control and documentation of various processes including product realization, supplier management, monitoring, production, corrective actions, quality assurance, and risk related activities. Therefore, ISO 13485 certification for medical device manufacturers can help build confidence amongst customers, regulators, suppliers and business partners.
Who to go for: How Manufacturers can select a Certification Body?
The first step for manufacturers when selecting a certification body is to check if the body is accredited by a recognized accreditation body. Accreditation offers extra assurance of conformity assessment practices that are in accordance with internationally accepted standards.
The manufacturer should also take into account the experience of the certification body in their particular type of medical product and their activities. The more relevant and efficient the assessment will be when provided by a provider that is familiar with the organization’s product category, manufacturing processes and target markets. It is also advisable to check the certification body’s audit approach, the scope of certification, the costs and time for certification and the requirements for surveillance on the certification process.
What is the Certification Process?
Usually, the process starts with a gap analysis that looks at the existing quality management system (QMS) of the organization and compares it to ISO 13485. The manufacturer then creates or enhances documented processes, quality goals, risk management processes, supplier controls, training systems, production controls, and any other processes required.
Once the system is in place, the organization usually performs internal audits and management reviews to ensure that the system is working properly. The certification body then conducts an external audit (usually this includes an examination of the management system and its implementation in practice). Where significant nonconformities are found the organisation should rectify them before certification is granted.
What’s the relevance of ISO 13485 to Medical Device Manufacturers?
By providing a framework for manufacturers to manage quality and processes that may impact the safety and performance of medical devices, ISO 13485 can assist them in developing a consistent method for controlling quality and managing processes. It can help enhance process control, documentation, traceability, supplier management and corrective and preventive activities.
Certification can also help in market access and give potential customers an idea of a manufacturer’s dedication to the recognised quality management practices. But note that no medical device can be marketed in any country having got ISO 13485 certified. Manufacturers will continue to meet the regulatory requirements of each target market.
What is the time required for ISO 13485 Certification?
The time required can vary based on the size and number of locations, complexity of the operation, the quality management system in place, product range and readiness for the certification audit of the organisation. A company that already has a quality system in place will need to prepare less than a manufacturer that is working on building a system from the ground up.
By undergoing a comprehensive gap assessment, preparing necessary documentation, training staff, establishing procedures, and carrying out internal audits before external certification audit, manufacturers can mitigate any unnecessary delays.
Conclusion
Manufacturers looking to get ISO 13485 certification for medical device manufacturers have an important step to take when selecting the right certification body. A quality management system may be evaluated by an accredited, experienced provider that can assist with demonstrating that the processes are compliant with the applicable ISO 13485 requirements.
Before the external audit, organisations aiming to be certified should first have a clear understanding of the processes that they are involved in and what improvements need to be made. By implementing, documenting, training the employees, conducting internal auditing and making management commitment, manufacturers can build a better quality management system and leverage iso 13485 certification for customer confidence and overall quality goals.
