Description
Development and implementation of a quality management system 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.
• 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.
