Quality System

Implementing, maintaining and improving the quality system in accordance with ISO 13485

Advice on introducing a quality system according to EN ISO 13485 and its subsequent certification by ON:


    • Quality manual (reviewing company operations/management, identifying those responsible for operations, quality policy, mission, vision, up-to-date organization chart, responsibilities, job profiles, process identification, quality manual).
    • Documenting procedures (Administrative Department, Sales and Marketing Department, Production Department, Quality Department, Warehouse, etc.).
    • Work instructions and control guidelines (identifying production processes, work instruction model / control guideline, final testing control guideline, internal calibration instruction).
    • Quality plans (quality plans, quality policy, training plan, calibration plan, maintenance plan, etc.).