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).
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