ISO 9001 -standard
ISO 9001 is the globally well-known basis for effective quality management systems.
ISO 9001 is the internationally well-known basis for effective quality management systems. The standard sets requirements for the quality management system of an organisation and provides tools for building and developing a quality management system. This makes ISO 9001 a good foundation for various management systems (e.g. ISO 13485). Thanks to its international renown, the standard serves as a competitive advantage and a form of positive marketing.
Kasve’s specialists are experienced in preparing, updating and auditing several ISO 9001 quality management systems to ensure compliance with the standard. We will help you with designing your system, identifying and describing processes, development and auditing. Kasve’s specialists are qualified as lead auditors performing audits for ISO 9001 compliant activities.
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We have helped a number of medicinal device manufacturers, testing and clinical laboratories, and start-ups develop their operations.
IEC 60601 -standard
IEC 60601 is a series of technical standards that describes the requirements for the safety and essential performance of medical electrical equipment.
IEC 62304 -standard
IEC 62304 defines the set of processes for life-cycle management of medical device software.
ISO 13485 -standard
The ISO 13485 standard sets a frame for quality management systems for both medical device manufacturers and other organisations in the chain.