Risk Management in AS9100C

In the new revision of the AS9100 standard, an emphasis is being placed on clause 7.1.2 – Risk Management. This is a new requirement to implement a risk management process applicable to the product and organization covering responsibility, criteria, mitigation, and acceptance. The purpose of adding risk management in clause 7.1.2 is to provide additional focus on product risk during product realization.

Unlike ISO/TS 16949 which makes a reference to the Failure Mode and Effects Analysis (FMEA) process or ISO 13485 which references ISO 14971 for guidance on risk analysis, AS9100 is less prescriptive about how this should be done. This lack of specificity should not be interpreted as a simple suggestion for risk analysis, but rather as a flexible mandate that allows an organization to choose the best method of analysis appropriate to the product.

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