As part of (quality) care, a company has to deal with CE marking, ISO as well as product liability. What is the difference?
CE marking indicates that the installation or product complies with the minimum safety, environmental and health requirements. In addition, a user manual and risk analysis play a very important role. The Declaration of Conformity indicates that the manufacturer complies with the applicable Directives.
ISO concerns the (quality) care and control of the entire business. Procedures and rules are such that the customer can expect the company to fulfill 100% of the requirements set by himself. A good ISO system means that communication cannot be missed and that any deviations in the procedure are immediately signaled.
If a company is ISO certified, it says nothing about the quality of the product. If you sell junk, you can also be ISO certified.
To prove that the product meets all basic European requirements it also requires rules and procedures. A CE procedure will be part of a separate care system. The control of this (e.g., monitoring change procedures, processing data) will be part of the ISO system in an ISO certified company.
However, the substantive design of the CE system will not be tested by ISO. After all, the certifying body is not competent and has no knowledge of this!