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What are the major changes to the nonconformity management procedure according to the new version of ISO 9001:2015 ( vs. ISO 9001:2008 )? The answers to this question can be found in ISO 9001:2015 Transition Gap Analysis Transition Guidelines . Nonconforming process outputs, products or services are the object of control ( ISO 9001:2008 defined nonconforming products as an object of control ). Thus, the requirements where extended: ‘The organization shall deal with nonconforming outputs in one or more of the following ways: a) correction ( vs. ‘to eliminate the detected nonconformity’ in ISO 9001:2008 cl.8.3. a ); b) segregation, containment, return or suspension of provision of products and services; c) informing the customer; d) obtaining authorization for acceptance under concession: ( In ISO 9001:2008 this was worded as follows: ‘by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer’ (cl.8.3. b) ...

A saying ' The devil is in the detail ' is 100% applicable to the QMS transition to the new version of ISO 9001:2015. The requirements wording of the Standard is often confusing while the decisions to be made are very important. We start publishing Questions that other users encountered in the process of their QMS transition with our Answers. If you have a QMS related question - please email it to support@c-bg.com   and will do our best to get you an expert opinion. Question : I disagree that ISO 9001:2015 'Corrective Actions' Procedure does not includes preventive actions functions. The verbiage ‘preventative’ was removed, but the functions of preventative actions are still required, right? Answer : ‘Corrective actions’ Procedure regulates the response to the occurred nonconformity, including correction, identification and elimination of the causes of this nonconformity. When a nonconformity occurs, including any arising from complaint...