ISO 13485 Clause 6

The resources the quality management system needs: providing resources, personnel competence, infrastructure, and the work environment.

What each part covers

6.1

Determine and provide the resources needed to implement the system and keep it effective.

6.2

Personnel whose work affects product quality must be competent on the basis of education, training, skills, and experience.

6.3

Document the infrastructure needed to achieve product conformity, prevent product mix-up, and ensure orderly handling of product.

6.4

Document the work environment requirements needed to achieve product conformity.

Where it is written

ISO 13485:2016, clause 6

Also called

clause 6, ISO 13485:2016 clause 6

Related terms