Other services
Infrared termography, implementation of ISO concept, inspections, business premises for rent.
Implementation of the ISO concept
TSÚ Piešťany, š.p., provides its customers with:
Analysis of the current state
We will find out to what extent the reality in the field of quality assurance in your company corresponds to the requirements of ISO standards.
Employee education
We will prepare an educational program for your employees in the field of quality assurance.
according to the standards:
ISO 9001:2015 Quality management systems. Requirements
ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes
ISO 19011:2018 Guidelines for auditing management systems
ISO 14971:2019 Medical devices. Application of risk management in medical devices
according to legislation:
EU Regulation 2017/745 on medical devices
Description and documentation of the quality system
ISO standards uncompromisingly require that all activities that ensure quality in the company are described in a set of documents. Developing quality documents under the guidance of an experienced professional is the most effective way to achieve compliance with ISO requirements.
TSÚ Piešťany, š.p., provides its customers with:Analysis of the current state
We will find out to what extent the reality in the field of quality assurance in your company corresponds to the requirements of ISO standards.
Employee education
We will prepare an educational program for your employees in the field of quality assurance.
according to the standards:
ISO 9001:2015 Quality management systems. Requirements
ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes
ISO 19011:2018 Guidelines for auditing management systems
ISO 14971:2019 Medical devices. Application of risk management in medical devices
according to legislation:
EU Regulation 2017/745 on medical devices
Description and documentation of the quality system
ISO standards uncompromisingly require that all activities that ensure quality in the company are described in a set of documents. Developing quality documents under the guidance of an experienced professional is the most effective way to achieve compliance with ISO requirements.
List of contacts
Ing. Marcel SVOBODA
Head of CERTITECH
Head of CERTITECH
Ing. Jaroslav KMENT
Department Operator
Department Operator
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