ISO 13485:2016 is the latest applicable version of ISO 13485, which is a set standard for quality management system, specifically for the design and manufacture of medical devices. This is one of the critical areas in healthcare industry and monitoring of the quality in this filed has a completely different meaning. ISO 13485:2016, however, is a standard that focuses on the process rather than quality of the product itself. This standard aligns with the requirements of ISO 9001:2008, but does not incorporate the changes specified in latest version of ISO which is ISO 9001:2015. It was deemed that the revisions detailed in ISO 9001:2015 were not essential for medical device industry.
- Features and Benefits
- Applicability
- Consulting Methodology
This certification can be a strategic tool for any business that deals with medical devices. Many companies seek this certification because of the potential financial benefits if offers. The organizations must demonstrate their commitment by complying to the regulations set by this standard, in order to gain maximum rewards.
ISO 13485 and CE marking
ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives and Regulations.
Although ISO 13485 certification is not mandatory for CE marking medical devices under the European Medical Device Directives (AIMDD, MDD, IVDD), it is harmonized, which allows the presumption of conformity to the Directives.
ISO 13485 is also not mandatory for CE marking under the European Medical Device Regulations (MDR, IVDR). Although there are currently no standards harmonized to the Regulations, ISO 13485:2016 remains a state-of-the art document. BSI, as one of the leading Notified Bodies for CE marking, can verify medical device manufacturers’ selection of the most efficient conformity assessment routes to achieve CE marking.
Like any other ISO standard, 13485:2016 too can help reduce costs, increase consumer satisfaction, extend reach to new markets and improve performance. The companies will be able to define process for within its operations, including having an effective risk analysis. Development of products will be more user-centric and enhance overall performance. This will increase confidence in the company and raise its overall image in the market.
Any company, regardless of size, is entitled for ISO 13485:2016, as long as it deals in some way with the medical device industry. The standard can be applicable to suppliers as well as external parties who associate with medical device manufacturers.
Companies involved in any stage of the life-cycle of a medical device can apply for this standard. Some of the fields where ISO 13485:2016 can be implemented include:
- Design and development
- Production and storage
- Distribution
- Installation
- Servicing
The standard, requiring compliance with international regulations, aims to help companies provide medical devices and related services that consistently meet customer needs. It helps streamline the processes, with the emphasis on traceability in supply chain, assistance provided to customers, internal reviews and audits.