Development and implementation of a management system / Biomedicine / Services

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Quality management in an organization for the purpose of further certification for compliance with the requirements of GOST ISO 13485-2011 (ISO 13485: 2003) “Medical Products. Quality management systems. System requirements for regulatory purposes.

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• Works and services in preparation for certification:
- Carrying out diagnostic audits (organization survey, comprehensive internal audit) for compliance with certification requirements.
- Collection of documents (technical file) in accordance with the requirements of the certification body.
- Conducting workshops for staff on the implementation of the requirements of technical regulations, regulations, rules, standards in the processes for certification.
- Methodical assistance in the development of internal documentation in accordance with the requirements of standards.
- Maintenance of certification audit conducted by a certifying authority.

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