ISO 13485: What are the benefits?
Implementing a quality system from scratch requires hundreds of hours of planning, coordination and preparation of over 50 controlled documents. You may imagine the time and effort put towards this accreditation project along with a substantial investment.
Once the paperwork is completed, the registrar ensures that the accredited company has properly implemented the quality system by performing a comprehensive audit.
The procedure is intensive and time-consuming, however, the significant benefits of becoming an ISO certified company justifies the effort and investment
ISO 13485 is based on ISO 9001 but the requirements are specific to design and manufacturing in medical device industry.
Here are several advantages of being an ISO certified company:
- ISO creates a standardized process to apply to all development projects and ensure consistent results.
- It is a powerful tool as it provides a framework that is compatible with every company yet is flexible to the unique features of each business.
- ISO processes ensure the business runs efficiently and consistently while allowing the management to monitor business performance.
- ISO registration makes it easy to work with new customers who are also ISO companies because ISO companies are not required to be audited by customers which saves time.
- ISO 13485 is a commitment to continual improvement and customer satisfaction. It is a commitment to creating safe and effective medical devices.
Being an ISO certified company improves processes and ensures the quality consistency by defining requirements and standards. As companies are educated on ISO 13485 benefits, it’s becoming a sought-after quality system in medical devices industry.
Our ISO procedures ensure that for each project we are required to perform and document specific tasks such as defining requirements, performing design reviews, risk analysis, defining budgets, schedule, design verification protocols and more. Symbient implemented ISO 13485 in 2011 and we have acquired a very detailed quality system. ISO procedures allow us to achieve superior project management at a lower cost for our customers. We also ensure that the products that we develop meet regulatory requirements and that we have the flexibility to provide design control procedures for our customers.