6.1 Provision of resources

The organization shall determine and provide the resources needed to:

a) implement the quality management system and to maintain its effectiveness;

b) meet applicable regulatory and customer requirements.

6.2 Human resources

Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills, and experience.

The organization shall document the process(es) for establishing competence, providing needed training, and ensuring awareness of personnel.

The organization shall:

a) determine the necessary competence for personnel performing work affecting product quality;

b) provide training or take other actions to achieve or maintain the necessary competence;

c) evaluate the effectiveness of the actions taken;

d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives;

e) maintain appropriate records of education, training, skills, and experience (see 4.2.5).

NOTE: The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided.