Even though there wasn’t a marked difference in my layout abilities before and after I obtained an industry certification, it marked a critical moment of skill recognition in my career. However, it also meant that work carrying my name would require a higher standard with the backing of the certification. Like Uncle Ben said, “With great power comes great responsibility.”
Arguably, the greatest responsibility is for the medical field, where errors or faulty devices can cause significant harm. One of the most critical standards, therefore, is ISO 13485 certification. An organization must be certified to this quality management standard for the medical devices industry, and the entire supply chain must also follow these stringent requirements. Notably, that includes contract manufacturers for PCBs where the bare board and components are combined to form a populated assembly. The ISO 13485 certification key elements ensure that a facility carrying that certification upholds the high standards for medical device manufacturing.
The Basics of ISO 13485 Certification
ISO 13485 is the quality management system (QMS) standard for the medical devices industry. It outlines specific requirements for implementing a QMS at an organization involved in designing, producing, installing, and servicing medical devices and related services.
An organization implementing a QMS has documented processes, procedures, and responsibilities to achieve quality objectives and policies. The organization’s activities and processes coordinate to meet customer and regulatory requirements and continually improve performance and efficiency.
ISO 13485 certification is not a standard requirement, and many organizations benefit from implementing the standard without getting certified. However, certification demonstrates to regulators and customers that the organization has implemented and maintained a QMS according to the standard’s requirements.
Comparing ISO 13485 With ISO 9001 |
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| ISO 13485 | ISO 9001 |
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While related, ISO 13485 certification does not imply ISO 9001 certification!
ISO 13485 Certification: Key Elements for PCB Manufacturers
When it comes to ISO 13485 certification, certain elements are crucial for medical PCB manufacturing, such as:
Device Quality Regulations |
As a maker of medical devices, several regulatory bodies check a device’s compliance before a product arrives on the market. These include the FDA, the World Health Organization, and the International Electrotechnical Commission (IEC). Part of being certified to ISO 13485 is taking on promotion and awareness of regulatory requirements as a management responsibility. |
Documenting Quality Control |
For any PCB manufacturing (especially PCBs used in medical devices), manufacturing quality control processes are essential to the final product’s success. ISO 13485 certification requires documented quality control over all manufacturing phases so that production proceeds according to industry regulations. |
Risk Management |
Another crucial factor in the success of building products is that the manufacturer is working toward mitigating any problems that might impact production. For instance, implementing a process to review all components used on a product before production will help target any components that might be in jeopardy of obsolescence or reaching end-of-life and detrimentally impacting future production. |
Traceability |
ISO 13485 also defines the criteria for documenting all components and materials used during production. Suppose there is a situation where a manufactured product or its components need to be traced back to their origins for recall purposes. In that case, ISO 13485 requirements significantly reduce the associated difficulty. |
Analysis and Refinement |
ISO 13485 certification demonstrates that a manufacturer has developed standards for monitoring and improving performance. A system of audits and feedback, and a thorough analysis of that data, facilitates corrections and improvements in their processes as needed. |
Your Contract Manufacturer Has a Handle on ISO 13485 As It Evolves
A CM with ISO 13485 certification ensures that a medical device will proceed according to all the pertinent market regulations. Further advantages design teams can expect from a CM who is ISO 13485 certified include:
- A comprehensive understanding of the requirements of ISO 13485 that acts as a guide and informs clients how the standard will affect the production of your product.
- Tightly controlled documentation processes keep the product record current, accurate, and fetchable. This benefit extends to the components used in assembly and the bare board materials used in the fabrication.
- Production and test processes that are understandable and easily auditable under the protocols of the medical device industry.
- Experience producing multiple medical product types. Achieving ISO 13485 certification signals that a CM is at the forefront of the medical device PCB manufacturing industry.
- Partnerships with component suppliers that comply with medical device quality standards ensure the highest quality in producing a medical PCB. In current times of shortages, any advantage to procurement (even verification of origin source) can go a long way toward maintaining stock.
At VSE, our engineers build electronics that adhere to ISO 13485 certification for our customers. Our processes are well documented, allowing us to track the history of any of our builds during an audit. We have also built medical devices for decades, giving us plenty of experience with multiple medical device types. Finally, we have extensive relationships with our component suppliers to provide you with the highest quality PCB build possible.
