The organization should determine (P) and select (C) opportunities (6.1) for improvement (10) and implement any necessary actions and changes to the innovation management system (4.4), considering performance evaluation (9) results (7.5).
The organization should consider (P) actions and changes to:
a) maintain (A) or enhance (A) strengths (6.1);
b) address (A) weaknesses and gaps (6.1);
c) correct (A), prevent (P), or reduce (A) deviations and nonconformities (10.2).
The organization should ensure that actions (A) and changes are implemented (A) in a timely (7.1.3), complete (4.3), and effective (9) manner.
The organization should communicate (7.4) actions (A) and changes (A) within (4.3) the organization and to other relevant interested parties (4.2), in order to stimulate (7.3) learning (7.1.4) and improvement (10).
A deviation (10.2) can be described as an identified gap (10.2), an undesired (10.2) effect (9), or a difference (10.2) from the expected performance (9), whereas a nonconformity (10.2) is the non-fulfilment (10.2) of a requirement (7.5).
10.2.1 When a deviation or a nonconformity occurs, the organization should:
a) react (A) to the deviation or nonconformity and, as applicable:
1) take action to control (C) and correct (A) it;
2) deal (A) with the consequences (6.1);
b) evaluate (C) (9.1.2) the need (4.2) for action to eliminate the causes of the deviation or nonconformity, in order that it does not recur or occur elsewhere (4.3), by:
1) reviewing (C) and analysing (A) (9.1.2) the deviation or nonconformity;
2) determining (P) the root causes of the deviation or nonconformity;
3) determining if () similar deviations or nonconformities exist, or could potentially (6.1) occur;
c) implement (A) any action needed;
d) review (C) the effectiveness (9) of any corrective action taken;
e) update (A) opportunities and risks (6.1) determined during planning (6), if necessary;
f) make changes (A) to the innovation management system (4.4), if necessary.
Corrective actions should be appropriate (D) to the effects (9) of the deviations and nonconformities encountered.
10.2.2 The organization should retain (A) documented information (7.5) as evidence (7.5) of:
a) the nature of the deviations or nonconformities and any subsequent actions taken;
b) the results (7.5) of any corrective action.
The organization should continually improve (A) the suitability (4.1), adequacy (4.1), effectiveness (9), and efficiency (9) of the innovation management system (4.4).