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/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 occupational health and safety
    (The BS OHSAS 18001:2007 looses its validity per September 11, 2021 and will be replaced by the ISO 45001.)

  • Certification of quality management systems of medical device manufacturer

  • (The certification by SQS is not offered any longer. Existing certificates stay valid until the end of their validity.)

  • Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    (The certification by SQS is not offered any longer. Existing certificates stay valid until the end of their validity.)

  • Asset Management
    (For any further information concerning the product please contact the product responsible, Mr. Silvio Genovese.)

Guidelines

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.)

Daniel Taddeo
I will gladly take time for you!

+41 58 710 33 83

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