Importance of ISO 13485 Certification Companies

Posted by Dave on May 18th, 2021

ISO 13485 certification was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS.

Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widens market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators Companies that have implemented ISO 13485 cite numerous benefits. Many companies seek the ISO 13485 2016 Certification because of the financial benefits to their business. The certification demonstrates its commitment to building high-quality medical devices. That allows companies to attract more clients than before.

Benefits of implementation of ISO 13485 certification companies:

• Ability to contract with larger companies:Many large medical device companies prefer to work with who are ISO 13485 certified suppliers. The large companies are responsible for ensuring that any subcontractors comply with ISO 13485 standards
• Demonstrate commitment to high quality:Achieving a quality management certification demonstrates to customers that your company appreciates quality
• Expand and Consolidate Company Knowledge:This knowledge can help to identify problems, improve the product, and simplify the production process. It also facilitates the process of incorporating new employees.

ISO 13485 is recognized by the Global Harmonization Task Force (GHTF) and has become the model QMS standard for the medical industry, and in major markets around the world.A well-run operation with processes under control leads to financial rewards for your hard work and investment in the Quality Management System.  It has been observed that QMS certified companies have shown improvements in financial performance as compared to uncertified ones.Many organizations decide to implement ISO 13485 and obtain registration because it assures customers that the company has a good Quality Management System (QMS). An organization with an effective QMS will typically meet customer expectations better than an organization that does not have one.  This is because the Goals and Objectives of the QMS take the customer needs into account.  As goals focus on the customer, the organization spends less time focusing on individual goals of departments and more time working together to meet customer needs.With the QMS in place and working for the organization is focused towards the Quality Goals. Management is provided with data on  continual basis and able to see progress or lack of progress towards goals and take appropriate action.