Overview of ISO 13485 Certification: Who Needs It and Why

 ISO 13485 is the designated standard for quality management of medical devices. A Quality Management System (QMS) is the most indispensable management system needed in every business to help meet their customers’ needs continuously. In other words, it helps in maintaining a business’s position or competitiveness in the market. Since the medical device industry must focus specifically on maintaining the quality and reliability of products for patients’ safety, the ISO 13485 certification is instrumental for their QMS. Here is why businesses in the medical device industry should be conscious of the certification and why it is important. 

What is the ISO 13485 Certification?

ISO 13485 was clearly designed to assist manufacturers or businesses in the medical device industry with a powerful QMS. To achieve this certification, they need to standardize their processes and adopt effective quality management practices. It ensures that there is consistency in all the phases of production as well as delivery, making every medical device safe for the treatment or intended purpose.

ISO 13485 is also designed to be used by manufacturers through the lifecycle of a medical device, i.e., from its initial designing and conceptualization to use and disposal. It reflects their strong commitment to quality management throughout and ability to ensure the safety of devices, even postproduction. Therefore, customers become confident about the reliability of devices which brings them considerable sales.

Who Needs the ISO 13485 Certification?

The ISO 13485 certification is applicable for all businesses operating in the medical device industry, regardless of their size. The business can be a specialized manufacturing company, a manufacturer of an intermediate part or a services provider which repair, refurbish, or improve medical devices. Clearly, any business directly or indirectly handling medical devices need the certification to prove their conformity to best quality management practices. 

Why the ISO 13485 Certification is Crucial for Medical Device Businesses?

Though it is not mandatory, organizations in the medical device industry must get the certification to have the most effective quality management approach. If you are one of them, getting the certification is beneficial because it not only helps in fulfilling your quality assurance commitment but also in maintaining your organization’s credibility. Maintaining brand image and credibility is essential for companies in the medical device industry because patients, hospitals, or healthcare organizations tend to rely on the products of companies that demonstrate their quality compliance. 

With attaining the ISO 13485 standard, these are potential benefits that your company can get in short term and long term. 

• International recognition and credibility establishment which helps you gain potential for sales in the global markets

• Achieving of legal compliance with local as well as national regulatory requirements which makes your devices more acceptable to customers

• Enhancement in product safety, consistency and quality which assure the patients’ wellbeing. There are also devices or equipment procured by medical organizations and so it helps them to offer better treatment or diagnosis services to patients

• Significant lowering risks in the manufacturing or servicing of medical devices which helps enterprises earn the trust of customers  

• Improved decision-making by the manufacturers or organizations on basis of evidence and data collected through their QMS

• Improvement in customer care services and complaints handling which helps organizations to increase their customer satisfaction

Key Takeaway!

By now, you understand why the ISO 13485 certification is an imperative condition for your medical devices company. Achieving the standard assists you to have a comprehensive QMS which reinforces a holistic approach to quality assurance. It helps you to manage, control, or improve the processes in your production cycle to ensure safer and superior-quality medical devices. While it benefits your company internally in this way, externally it offers a lot of other advantages to your business. Increase in credibility, competitive advantage, and ability to win big contracts are some noteworthy advantages that eventually come forth with achieving the certification.  

Contact Details:

Business Name: Compliancehelp Consulting, LLC

Email Id: info@quality-assurance.com

Phone No: 877 238 5855

Also Read: Quality Auditing Techniques that are Critical Success Factors for Businesses