Whether you are in an elevator or at the doctor’s office, one of the first things that you will probably notice is a certification of some sort hanging on the wall. Certifications provide consumers with the assurance that the product or services that they are using will perform or give them the results that they expect.
When you’re in the medical device industry, certifications are critical, as there are several standards and regulations you must adhere to when marketing products in this space. One of the most important standards, however, is ISO 13485. Not only must your organization be certified to this quality management standard for the medical devices industry, but it is important to ensure your entire supply chain is also following these stringent requirements. That includes your contract manufacturer for your PCBAs. Here’s a closer look at the ISO 13485 certification key elements and how having that certification in place by your PCBA contract manufacturer will benefit you.
The Basics of ISO 13485
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 the design, production, installation, and servicing of medical devices, as well as any related services.
When an organization implements a QMS, it means it has documented processes, procedures, and responsibilities in place to achieve quality objectives and policies. All of the organization’s activities and processes are coordinated to meet customer and regulatory requirements, as well as continually improve effectiveness and efficiency.
Certification to ISO 13485 is not a requirement of the standard itself, and many organizations benefit from implementing the standard without actually getting certified to it. Achieving certification, however, demonstrates to regulators and customers alike that the organization has implemented and maintained a QMS according to the requirements of the standard.
ISO 13485 Certification: Key Elements for PCBA Manufacturers
When it comes to ISO 13485 certification, there are certain elements that are especially crucial for medical PCBA manufacturing. These elements include:
- Knowledge of other medical device quality regulations. As a maker of medical devices, there are a number of regulatory bodies that you must work with to successfully bring your product to market. These include the FDA, the World Health Organization, and the International Electrotechnical Commission (IEC) among others. Part of being certified to ISO 13485 is taking on promotion and awareness of regulatory requirements as a management responsibility.
- Documented manufacturing quality control processes. For any PCBA manufacturing, and especially PCBAs that are used in medical devices, manufacturing quality control processes are essential to the success of the final product. ISO 13485 certification requires documented quality control over all phases of manufacturing so that products are being manufactured according to industry regulations.
- A focus on risk management and design control processes. 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, having a process implemented for the review of all components used on a product prior to production will help to target any components that might be in jeopardy of going end-of-life and hurting future production.
- Documented traceability of materials, components, and processes. ISO 13485 also defines the criteria for a process of documenting all components and materials used during production. This is important in case there is ever a situation where a manufactured product or any of its components need to be traced back to their origins for recall purposes.
- Analysis and Improvement. ISO 13485 certification demonstrates that a manufacturer has developed standards of monitoring and improving their own performance. They are set up with a system of audits and feedback, and through analysis of that data will make corrections and improvements in their processes as needed.
Partnering with a CM that has obtained ISO 13485 certification will demonstrate to you that your CM has the QMS in place to ensure your medical device will be manufactured according to all the pertinent regulations you need to bring your product to market.
Benefits of Partnering with an ISO 13485-Certified CM
When choosing a CM to product your medical PCBA, there are some distinct advantages you can expect from a CM who is ISO 13485 certified, including:
- A complete understanding of the requirements of ISO 13485. Your CM will be able to explain and guide you through how the standard will affect the production of your product.
- Tightly controlled documentation processes that keep the product records, including all component and materials used for production, current, accurate, and retrievable.
- 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 a leader in the medical device PCBA space.
- Partnerships with component suppliers that are also compliant to medical device quality standards, ensuring the highest level of quality in the production of your medical PCBA.
At VSE, we are ISO 13485 certified and have implemented and maintained our quality management system according to that standard. Our processes are well documented, giving us the ability to track the history of any of our builds during an audit. We have also been building medical devices for decades, giving us plenty of experience with multiple medical device types. Additionally, we have extensive relationships with our component suppliers so that we can give you the highest quality PCBA build possible.
