ISO 13485:2016
Measurement, analysis and improvement – ISO 13485:2016

ISO 13485:2016 8.2.2: Complaint handling

The organization has documented procedures for handling complaints promptly, as the regulatory requirements that apply demand. At a minimum these procedures set the requirements and responsibilities for: receiving and recording information; deciding whether a piece of feedback counts as a complaint; investigating complaints; deciding whether the information needs to be reported to the appropriate regulatory authorities; handling product connected to a complaint; and deciding whether corrections or corrective actions must be started. If a complaint is not investigated, the reason is documented, and any correction or corrective action that comes out of complaint handling is documented. If an investigation shows that activities outside the organization played a part, the relevant information is shared with the outside party involved. Records of complaint handling are kept.

Maintained by Gerard BlokdykControl text last updated

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This control maps to 6 controls across 5 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

APPI · 1 control

  • SD134-16 Complaint Handling

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.

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