Quality in the healthcare sector
SQS assesses and certifies quality standards in the healthcare sector.
The manufacturing of products for the healthcare sector is subject to very strict quality requirements. The focus is on the requirement to meet the highest standards for maximum patient safety and for consumers. SQS certifies the quality management systems of medical product manufacturers (ISO 13485) and assesses medical products for conformity with the relevant EU directives. Specific assessment processes are used for each product. A positive assessment leads to authorisation to use the CE mark and to place medical products on the market.
Synergies through combination
The specific mechanisms for quality assurance in the healthcare sector can be advantageously combined with other standards to create interesting synergies. The focus is on standards ISO 9001 (quality management), ISO 14001 (certification of environmental management systems) and ISO 45001 (occupational health and safety protection).
Overview of the offer
Main standards
Certification of quality management systems
Certification of environmental management systems
Certification of occupational health and safety
Certification of quality management systems of medical device manufacturer
Guidelines
Conformity assessment of medical devices
Joint audit program of the authorities for medical devices of USA, Canada, Japan, Brazil and Australia. The certification is carried out in cooperation with DQS.
Conformity assessment of medical devices
Appendix
(For any further information concerning the product please contact the product responsible, M. Daniel Taddeo.)
(For any further information concerning the product please contact the product responsible, M. Daniel Taddeo.)
(For any further information concerning the product please contact the product responsible, M. Daniel Taddeo.)
(For any further information concerning the product please contact the product responsible, M. Daniel Taddeo.)
