ISO 13485:2016
Resource management – ISO 13485:2016

ISO 13485:2016 6.2: Human resources

Anyone doing work that affects product quality must be competent, as shown by suitable education, training, skills and experience. For this, the organization documents its processes for building competence, giving the training needed and making people aware. It determines what competence the work affecting product quality requires; provides training, or acts in other ways, to reach or keep that competence; checks whether the action taken worked, using a method in proportion to the risk of the work; makes sure staff understand why their work matters and what it contributes to the quality objectives; and keeps suitable records of staff education, training, skills and experience.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 2 controls across 2 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • ACQS-7 Human Resources

ISO/IEC 42001:2023 · 1 control

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Resource management – ISO 13485:2016

Query this from an agent

The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.