Medical offers

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 OHSAS 18001 (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 (The standard ISO 13485:2003 lost its validity by August 30, 2012 and was replaced by the revision 2012.)
Certification of quality management systems of medical device manufacturer (The standard EN ISO 13485:2012 looses its validity per 28.02.2019 and will be replaced by the revision 2016.)
Certification of quality management systems of medical device manufacturer
(For any further information concerning the product please contact the product responsible, Mrs. Karin Schulze.)

Guidelines

Certification of quality management systems for medical device manufacturers based on CMDCAS. This is performed under a cooperation agreement with DQS Medizinprodukte GmbH. Responsibility lies solely with DQS Medizinprodukte GmbH.
Conformity assessment of medical devices

Appendix

(For any further information concerning the product please contact the product responsible, Mrs. Karin Schulze.)
(For any further information concerning the product please contact the product responsible, Mrs. Karin Schulze.)
(For any further information concerning the product please contact the product responsible, Mrs. Karin Schulze.)
(For any further information concerning the product please contact the product responsible, Mrs. Karin Schulze.)

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