DIN EN ISO 13485 is an international, process-oriented standard and specifies requirements for a quality management system that essentially relates to product safety and the fulfillment of specific requirements for medical products.
The application of the ISO 13485 standard results from the obligation for manufacturers that their medical device must be subject to certain directives (market, service and application) in the European Union (European Directive on Medical Devices and its Accessories 93/42/EEC). Medical products must meet the criteria of safety and reliability in the development, production and marketing, as well as criteria for the reduction of risks. Medical products must also be technically and technically effective within the purview of the manufacturer's intended purpose.
A further prerequisite for the marketability of medical devices is legal requirements (law on medical devices). These require the demonstration of suitability and usefulness in case of professional selection and application within the scope of a medical indication.
A certification of the quality management system according to EN ISO 13485 is associated with a detailed documentation and an obligation to provide evidence. It serves to represent the conformity with the legally regulated areas and at the same time to ensure the effectiveness of the processes introduced. Both customers and national authorities expect proof of this conformity.
ISO 13485 is, in many respects, identical to ISO 9001, since it contains, in addition to the sector-specific requirements, almost all requirements of the ISO 9001 standard. However, there is no complete conformity. There is no binding link between the two standards. The application of ISO 9001 is voluntary and requires that organizations strive for continuous improvement (quality management).
The benefits of ISO 13485 for your company:
- Establishment of a deliberately introduced risk management
- Compliance with specific directives, legal regulations, contractual agreements
- Proof of risk minimization and effective handling of (product) risks
- Risk management activities during product development, manufacturing and service delivery
- Documentation, burden of proof and validation of processes
- Increased transparency and efficiency of internal processes
- Continuous improvement of the quality of medical products
- Ensuring product safety through inspection of the work environment
- Traceability of medical products (e.g., medical devices)
- Increased customer and employee satisfaction
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