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ISO 13485 is an International Organization for Standardization (ISO) standard designed for medical devices. It is particularly needed for businesses that are engaged in producing, designing, servicing, or installing various medical appliances. This certification is an important credential required by organizations to keep the customers and professionals safe in hospitals, clinics, and other medical environments.
ISO 13485 identifies requirements for a quality management process where an organization requires demonstrating its capability to offer medical devices and related services that constantly meet client and applicable regulatory requirements. It classifies requirements within quality management systems for suppliers, contract service, manufacturers, and distributors of medical devices and equipment. The main aim of the standard is to facilitate synchronized quality management system requirements for regulatory purposes within the medical devices sector. The ISO 13485 standard was published for the first time in the year 1996. The current ISO 13485 version was published on March 1, 2016.
Benefits of ISO 13485 certification
ISO 13485 certification comes with several benefits which are as follows:
Improve the credibility and image of the company: ISO 13485 certification proves to the customers that your organization takes quality very seriously and that you have the right system to ensure it.
Improve your processes: It is much easier to discover new opportunities for improvements, using the process approach outlined in ISO 13485.
Develop customer satisfaction: The ISO 13485 standard is established on a set of quality management rules, one of which is guaranteeing customer satisfaction. This can be attained by evaluating and attending to the expectation of the need of the customers.
Better decision-making: Another benefit of having ISO 13485 certification is that it allows the use of evidence-based decision-making that tends to be better aligned with the strategic principles of the company.
Build a culture of continual improvement: When the concept of continual improvement is adopted as the culture in your company, employee and management will always be on the lookout for methods to improve on how things are prepared.
Better employee engagement: The more the employees of your company understand their part in delivering quality services and products, the more engaged they are which leads to increased productivity and efficiency.
Gives more market access: ISO 13485 certification will increase the sales of your company by giving access to more markets.
Meet regulatory requirements: ISO 13485 certification will allow you to meet the regulatory requirements.
Brand equity: The certificate will show that medical devices are produced safely and meet high standards of quality.
Add a competitive edge: It will give your company a competitive edge in the market.
Apart from this, ISO 13485 certification will also help your company in various sectors like decreasing operating costs, setting up business credentials, improving relationships with stakeholders, entering global marketplaces, guaranteeing legal compliance, ensuring client satisfaction, and improving risk management.
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