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May I ask you to elaborate the kind of dangers are hiding for the bastards focusing on customer satisfaction and improvements?
Many thanks.
Many thanks.
"Customer satisfaction": In many cases, the supplier is the technical expert of the parts it makes. Unfortunately, sometimes, often driven by cost, customer will propose some requests/requirements which from the technical view/analysis may have an impact on the safety and effectiveness of the final product. In controlled industries, if a supplier/technical expert always says YES to a customer, possible consequences of non-compliance may occur in the future. Alternatively, always refer the regulators as your biggest customers and their satisfaction must be ensured.
Footnote: After all, continuous improvement and customer satisfaction are all "word play"s. Those vague and broad phrases can be interpreted and implemented in many ways to satisfy all industries. However, I think ISO 13485 purposely avoided those phrases to bring people out of the ISO 9001 mind-setting as a preventive action when a company evolves from 9001 to 13485. Welcome to the regulated world.