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Benjamin Rubeni, QA Manager - Aero Antenna Technology
What Is ISO 13485?
The medical device industry requires continual attention to detail, absolute precision, and impeccable quality standards. However, implementing a satisfactory ISO compliant quality management system (QMS) takes considerable time and effort, especially if you attempt to do so alone.
Even so, an ISO 13485-certified quality management system can cut costs, improve efficiency, and potentially save lives by ensuring that your procedures measure up to industry standards. Fortunately, regulations and guidelines provide a starting point for companies that specialize in medical devices manufacturing.
The internationally recognized regulatory requirements apply to every medical device sold in global markets, including Japan, Canada, Australia, and Europe. By imposing ISO 13485:2016-compliant standards and regulations, your company can quickly pinpoint risks, eliminate non-conformance, and prevent expensive accidents.
When the quality of your controls means the difference between life and death for patients worldwide, achieving ISO 13485 certification can increase confidence in your processes and products. Still, attaining the ISO 13485 standard or upgrading could take months.
At American Quality Management, our staff of experienced ISO 13485 consultants can help support your organization as you navigate the ISO landscape and ultimately help your organization certify. We’ll work alongside your team to conduct a risk analysis and implement personalized quality control systems that will help your business achieve its goals.
After implementation, we’ll train your key players to ensure that your company will be able to maintain your ISO 13485 certification. Finally, our staff will provide ongoing consulting service and support to keep your organization, your people, and your services moving forward in alignment with regulatory codes.
Benefits of ISO 13485 Certification
Implementing a quality system can improve your company’s processes in countless ways. That said, some of the main benefits of implementing ISO 13485:2016 regulatory guidelines include the following.
- Improved Public Image
Medical devices save lives every day. However, a non-conforming device could result in serious injuries – or worse.
By achieving compliance, your company will demonstrate a willingness to meet enhanced safety and effectiveness regulations. As a result, your company will enjoy improved credibility with current and future clients around the globe.
- Potential Long-Term Savings
If you watch the news on any given night, you will likely hear about costly recalls issued by manufacturers due to a lapse in quality or regulatory standards. Even if the company issued a voluntary recall, the expenses involved could soar to astronomical heights.
Improving your regulatory processes can help reduce or avoid manufacturing mistakes. By following the processes, you can consistently bring safe, effective products to market.
- Enhanced Efficiency
An ISO 13485 management system enhances the efficiency of your organization in a variety of ways. Our team of professionals will break down each step of your current process to ensure that it meets regulatory standards.
In addition, we will conduct an internal audit and management review to identify weaknesses, safety concerns, and bottlenecks within your production processes.
- Compliance with All Industry Regulatory Guidelines
Regardless of your role in the medical product life cycle, you must achieve ISO compliance to access most global markets. The international standard contains all of the requirements companies must follow to remain competitive in the worldwide medical instrument industry.
ISO Certification Process
When you work with our staff, you can count on experienced guidance, customized consulting services, and professional project management. We will guide your organization through the implementation, training, and certification process. Then, we will remain on call for questions, support, or ongoing consultation services.
While each business has unique demands, our standard process usually follows five steps:
- Customizing Your ISO 13485 Plan
Rather than applying a one-size-fits-all solution, we will conduct a review of your business to provide the best guidance possible. Depending on your circumstances, role in the production of medical devices, and manufacturing procedures, we will help you identify and execute the necessary steps to achieve a certificate.
Upgrading from ISO 9001:2015
As of March 1, 2019, medical device manufacturers must meet ISO 13485:2016 regulatory requirements to trade within the global market. That said, if your company has yet to upgrade from ISO 9001:2015 certification, you may miss out on valuable customer relationships and new markets in Europe, Asia, and beyond.
Our team will work with your team to review your systems, complete documentation, and internal testing, and oversee development.
- Enacting Your Medical Device QMS
Our consulting and project management services will ensure that your company has the support it needs to carry out your QMS plan on your schedule and within your budget. Our years of experience with the ISO 13485:2016 implementation process will result in a faster, less expensive, and risk-free route to certification.
- Training Key Team Members in ISO 13485 Requirements
Your organization will require more than consultants and project management services to maintain regulatory standards. We will work with your staff to train critical players, provide a free internal checklist for future training, and develop detailed regulatory procedures and documentation to aid in ongoing QMS support and development.
Further, we will help create documentation, which you can then use to improve the awareness of ISO 13485 and FDA requirements throughout your organization.
- Conducting an Internal Audit and Review of Your Plan
After training your staff, our team will conduct an internal audit and management review to identify any weaknesses in your QMS. We’ll also work with you to define the performance standards, proper analysis methods, and quality control measurements you need to maintain certification in the years following development and implementation.
If required, we can even recommend third-party testing organizations that specialize in your industry’s regulatory requirements.
- Developing an Ongoing Approach to Improving Your ISO 13485-Compliant QMS
As you may have guessed, the implementation of a management system is only the first step for most organizations. Like any other area of business, companies should always aim to improve their testing, manufacturing methods, and internal processes.
Our staff of experienced consultants will provide guidance to support your managers as they move forward while maintaining regulatory compliance throughout the production life cycle.
Working with an ISO 13485 Consultants for Medical Devices
Complying with ISO 13485 regulation can quickly improve your medical device products’ efficiency, cost-effectiveness, and conformation. However, meeting the standards without the support of experienced consultants can result in an expensive, drawn-out auditing process.
For more information on how our services can help, don’t hesitate to get in touch with our American Quality Management staff today at (323) 896-1803 or (323) 201-7266.