Monday, September 11, 2017

Nonconformity Management

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)).

Conformity to the requirements shall be verified when nonconforming outputs are corrected.’
ISO 9001:2015 Cl.8.7.1

ISO 9001:2015 provides more details regarding retaining of documented information (records) that:
‘a) describes the nonconformity;
b) describes the actions taken;
c) describes any concessions obtained;
d) identifies the authority deciding the action in respect of the nonconformity.’

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