5.4.03 Corrective and preventive measures

Aim and purpose

Corrective and preventive measures are based on an analysis of "undesirable events", internal audit reports, customer complaints, results of quality control and the evaluation of external experience (literature, individual case reports, e.g. from cases of damage). It must be regulated how the information is passed on, who orders corrective and preventive measures and how their implementation is monitored.

DIN EN ISO 9001:2015 and DIN EN 15224:2017 10.2.1 a), c) - g)

Area of application

Description

Documentation

The processing of corrective actions must be documented. A list must be drawn up containing: a) the type of non-conformity b) the corresponding corrective action c) the result of the corrective action

In the case of non-conformities affecting a patient, the corrective action must also be documented in the patient file

Resources

Responsibility and qualification

Notes and comments

Applicable documents

Literature

Terms

Attachments