Developing and manufacturing electronics for medical devices is a bonus for any other type of electronics, even those designed for use in the automotive industry.
ISO 13485 is a specific quality standard which is designed to ensure that the necessary requirements for an electronic application in a medical environment are met. This international standard sets out the requirements for a quality management system that an organisation must use when designing, developing, manufacturing, installing and providing services related to healthcare products.
ISO 13485 is implemented in organisations in order to prove that they are able to supply health products and related services that consistently comply with client requirements and any regulatory requirements which apply to health products and related services.
The standard supplements ISO 9001 but contains criteria that are specific to the healthcare industry, particularly with regards to traceability, sterilisation processes and controlling design, development and manufacturing records, among others.
These controls apply to organisations that supply healthcare products, regardless of the type or size of the organisation.
This means that organisations such as those listed below can be certified in accordance with ISO13485:
• Developers of electronic healthcare products
• Manufacturers of electronic healthcare products
• Suppliers of electronic healthcare products
• Services related to electronic healthcare products
• Electromedical services
• Hospital sterilisation departments.
With a view to improving quality in both design and manufacturing, IKOR is currently undergoing organisational changes so that both development and manufacturing will be certified by the end of the year.
This will signify yet another milestone that IKOR has reached in one of its key principles: designing and manufacturing electronic products while always ensuring the highest possible quality.
We’re sure to succeed!