ISO 13485:2016
Resource management – ISO 13485:2016

ISO 13485:2016 6.4.1: Work environment

The organization documents what the work environment must be like for product to conform. If conditions in the work environment could harm product quality, it documents requirements for those conditions and the procedures for monitoring and controlling them. If contact between staff and the product or the work environment could affect how safe the device is or how it performs, it documents requirements for the health, cleanliness and clothing of staff. Anyone who has to work for a time under special environmental conditions must either be competent or work under the supervision of someone who is.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

ISO 22000:2018 · 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 1 it maps to, and the evidence behind each claim, over MCP and REST.