Confirmation of compliance with GOST ISO requirements
Alphalab has successfully completed the environmental management system inspection process for the certificate of conformity with the requirements of GOST ISO 13485‑2017 (ISO13485:2016).
The audit included:
- evaluation and analysis of the organization's implementation of quality policy and objectives;
- verification of the implementation and management of management system processes;
- verification of procedures for performing activities established in the management system documentation;
- assessment of personnel qualifications and verification of the performance of tasks and responsibilities assigned to personnel by job descriptions and other management system documents;
- verification of compliance with documentation management rules and other requirements established by the quality manual and the organization's standards.
