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quality management
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Quality Management Quality Management |
But: |
plock consulting is be emphatic to hold cost and structure very low without cutting back the quality assurance and control which are regulated by the EN normative to keep and improve the quality of the customers products, working or process structure and consequently the success.
quality assurance
2.1.1 Development of Quality Systems (QMS) to meet FDA and ISO requirements (e.g. ISO 13485, ISO 9001)
2.1.2 Creation of standard operating procedures
2.1.3 Development of a device master record
2.1.4 Supplier qualification and auditing
2.1.5 Training
2.1.6 Quality System maintenance
quality control
2.2.1 Test plan development
2.2.2 Test method creation and validation
2.2.3 Stability program development
2.2.4 Contract testing of raw materials and finished product
2.2.5 Auditing (Internal and Supplier Audits)
2.2.6 GAP Analysis
special services
2.3.1 External quality management representant
2.3.2 External safety representant by german medical law §30
2.3.3 Forms for inspection & testing of medical equipments by sql
2.3.4 Develoment of databased final-check-equipment for medical & industrial products