Tag Archives: risk based approach

API Q1 Revision 9 and the Risk Based Approach

The extent that the “risk based approach” will affect the nature of ISO 9001 certification is a hot discussion topic at the moment. Obviously, with the actual standard still months away (we haven’t yet, at the time of writing even seen the FDIS) the debates are academic and hypothetical. However lately I have had some exposure to how the risk based approach may impact the QMS in a very practical way, having just started an API Q1 revision 9 project. Continue reading

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