Do you know how your contract manufacturer manages their product quality system? Some contract manufacturers for medical equipment electronics implement an outdated, unresponsive quality system that is most likely an amalgamation of paper documentation and unorganized entries in a spreadsheet. This type of quality system begins and ends with a small group of people in the company. It also happens to be highly inefficient, opaque, and unscalable. It also creates a danger that a medical OEM will be held liable in the event a product happens to malfunction or fail during operation.
Thankfully, the medical device and equipment industry and major standards organizations have come together to define standards on quality management systems (QMS) for ensuring quality in product design, as well as for auditing the reliability of their manufacturing process. An ISO 13485 contract manufacturer will have the experience required to navigate the ISO 9001 and ISO 13485 standards on quality management and provide greater transparency for their customers.
What Is ISO 13485?
Among the alphanumeric soup of industry standards that govern electronic devices and medical products, ISO 13485 is one of the most important standards for medical device designers and manufacturers. This standard defines a broad range of requirements on quality management system (QMS) for medical devices and equipment.
Specifically, ISO 13485 specifies requirements for organizations involved in one or more stages of the medical device life cycle. ISO 13485 expands on the QMS fundamentals defined in ISO 9001. Among the list of requirements in ISO 13485, device designers, engineering services firms, and manufacturers must comply with a list of documentation, management, design and development, traceability, documentation, auditing, testing, sterilization, and other production requirements.
When you look through the list of requirements in this standard, you’re likely to see some similarities to ISO 9001. These two certifications are not in competition—ISO 13485 is an extension of the quality and continuous improvement standards specified in ISO 9001, carrying greater specificity to the medical device industry. In contrast, ISO 9001 specifies generic requirements, allowing any organization, regardless of the products or services it provides, to implement the QMS procedures defined in ISO 9001.
Benefits of Working with an ISO 13485 Contract Manufacturer
Because the medical device and equipment industry is highly regulated, OEMs need assurance that their new products will be in full regulatory compliance once their products hit the market. In fact, the recent ISO 13485:2016 revisions have helped align medical device quality requirements with U.S. FDA requirements.
In particular, design and development, as defined within ISO 13485:2016, is consistent with the FDA design controls regulations as defined in 21 CFR Part 820.30. Working with an ISO 13485 certified manufacturer gives medical OEMs greater assurance that their products will pass the rigorous quality and safety requirements specified in FDA regulations.
Plenty of organizations and their clients can benefit when the practices outlined in ISO 13485 and other standards are implemented. Aside from regulatory requirements on medical devices and equipment, medical OEMs can see some important benefits when working with an ISO 13485 contract manufacturer:
- Product requirements: An ISO 13485 contract manufacturer ensures the production team, design team, and all other parties have a clear understanding of the end customer’s expectations and the product’s required functionality. This helps the design and production team prevent common errors that can arise during production and ultimately ensures user safety.
- Auditing and transparency: Any QMS should carry some level of transparency, both for auditors and even for customers. Many ISO 13485 contract manufacturers are willing to share audit outcomes with customers, showing they can be held fully accountable for product quality and safety.
- Reduced liability: Anyone that has paid attention to court settlements knows that litigation resulting from a failed piece of medical equipment can be extremely expensive. Medical OEMs can benefit from the traceability, design, and materials validation, risk assessments, and other processes implemented by an ISO 13485 contract manufacturer.
Although ISO itself does not require a contract manufacturer or other organization to seek certification under ISO 13485 or ISO 9001, some jurisdictions may require working with organizations that hold ISO 13485 certification before a medical product can be released onto the market. Working with an ISO 13485 contract manufacturer shows regulators and customers that your device was manufactured by an organization with a compliant QMS, ultimately improving your chances of passing qualification.
Working with an ISO 9001/ISO 13485 Dual-Certified CM
Many contract manufacturers are certified in either ISO 9001 or ISO 13485. VSE is unique among contract manufacturers in the electronics industry in that we hold both certifications. Now that specifications on medical equipment in ISO 13485 are beginning to better align with global regulatory requirements, the divergence between ISO 9001 and ISO 13485 is increasing. As a dual-certified contract manufacturer, we can help you navigate both standards on your next medical device.
As an ISO 13485 contract manufacturer, we’ve implemented a traceability and auditing system as part of our QMS, ensuring your next medical device will carry the documentation required to satisfy regulatory requirements. Our traceability, documentation, and auditing processes exceed industry standards and our customers’ requirements.
As part of our comprehensive QMS, we track inputs and outputs in each manufacturing operation for every technician in our facility. Unlike other manufacturers, we don’t view a QMS as a rigid system that inhibits our process. Our flexible system allows us to easily conform to our customers’ unique requirements.
