Over the years, the International Organisation for Standardisation (ISO, for short) has developed more than 17,000 internationally recognised standards on numerous subjects. Their role is, as the name would suggest, to standardise the processes and products in a certain field, so that a particular level of quality is met whenever it is necessary.
One of the industries that definitely needs to rely on high standards and safety is medical device production. For them, the most important standard is ISO 13485, which provides guidelines connected to quality management systems. Certification to ISO 13485 has many benefits, including increased efficiency, cost savings, effective risk management and quality assurance. However, implementation of said certification is not easy. To make the process better, companies specialising in QMS decided to develop software designed especially for ISO 13485.
Key ISO 13485 software features
Medical device producers face many challenges regarding ISO 13485 compliance. It requires companies to establish satisfactory quality systems and to implement quality procedures that are properly documented, controlled and maintained. Relying on a software that is able to check for imperfections and provide a clear guide of action can help device organisations achieve their regulatory goals as well as business goals. But what should actually such software entail?
First of all, it should be an explorer tool for easy document search and retrieval. Thorough documentation in the process of implementing certification regulations is necessary to obtain a certain level of quality and reliability. Having all documents sorted and saved in one, easy to access place is helpful during certification audits when the registrar will be assessing how well a company’s documented quality processes comply with ISO 13485.
Moreover, a software for ISO 13485 should serve as a risk management tool to help identify, minimise and track all risks related to products, processes and services. An ISO 13485 system must take a risk-based approach not only with its quality processes, but also the design of their products. The software should aid to make the risk management easier and more approachable.
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Medical devices are usually produced on a global scale, which is why outsourcing supplies is not an uncommon thing to do. Manufacturers cannot rely solely on the word of mouth and control the end product only – they need to be able to communicate with their suppliers and make sure that the elements they are getting are also compliant with ISO 13485. A good software should allow just that. Having all the elements mentioned, a proper ISO software will make an implementation and certification way easier.