Maps to
QMSR / ISO 13485: §820.198
ISO 13485: §8.2.2
Requirement text
The organization shall establish documented procedures for receiving, reviewing, and evaluating complaints. FDA-Plus: Each complaint must be evaluated to determine whether it constitutes a reportable event under 21 CFR Part 803 (MDR). Complaint investigation must determine if CAPA is needed. Records must be maintained and accessible for FDA inspection.
What changed
Part 820.198 established detailed, prescriptive requirements for complaint files including specific investigation procedures, documentation requirements, and mandatory linkage to MDR reporting under 21 CFR Part 803. ISO 13485 clause 8.2.2 addresses complaint handling within a broader feedback management framework but retains the core requirements for timely receipt, documentation, evaluation, and investigation of complaints.
The QMSR introduces new explicit requirements for complaint records in section 820.35. This section defines specific content requirements for complaint records, including when complaints must be investigated, making these expectations more detailed and explicit than what existed in the legacy QSR. Organizations must ensure their complaint handling procedures now meet both the ISO 13485 clause 8.2.2 requirements and the additional QMSR-specific complaint record requirements in 820.35.
ISO 13485 adds a requirement that Part 820 left implicit: complaint handling must feed into the broader feedback system (8.2.1) and must be linked to CAPA (8.5.2/8.5.3), regulatory reporting (8.2.3), and risk management processes. Where Part 820 treated complaint files somewhat in isolation, ISO 13485 positions complaint handling as an input to multiple interconnected quality subsystems. Each complaint must be evaluated not just for MDR reportability but also for CAPA need, trend significance, and risk management implications.
The FDA preamble commentary emphasized that complaint handling expectations remain stringent under the QMSR and that manufacturers should continue to evaluate each complaint for MDR reportability per 21 CFR Part 803. The shift to ISO 13485 does not reduce the rigor expected; it adds the process integration requirements on top of the existing complaint investigation expectations.
Atomic constraints
- •Documented complaint handling procedures must exist.
- •All complaints must be received, logged, and evaluated in a timely manner.
- •Each complaint must be assessed for MDR reportability (FDA requirement).
- •Investigation must determine root cause and whether CAPA is needed.
- •Complaint trending must be performed to identify systemic issues.
- •Complaint records must be maintained and retrievable.
Common gaps
Missing Complaint-to-CAPA Linkage Procedure
majorISO 13485 requires a documented process for evaluating each complaint to determine whether CAPA is needed. Many Part 820-era complaint procedures handle investigation and MDR evaluation but lack a formal decision gate for CAPA initiation, resulting in complaints being closed without systematic assessment of whether corrective action is warranted.
Inadequate investigation rationale
majorComplaints are closed with 'No investigation necessary' but the documented rationale is vague (e.g., 'known issue'). ISO 13485 requires a specific rationale for not investigating.
No Systematic Complaint Trending
moderateISO 13485 requires that complaint data be trended to identify systemic issues. Many organizations trend complaints informally or only at management review, without a defined frequency, statistical method, or escalation threshold for when trends trigger CAPA or risk management action.
Incomplete Complaint Record Content
moderateQMSR section 820.35 defines specific content requirements for complaint records that are more detailed than the legacy QSR. Organizations may lack fields for risk classification, CAPA determination rationale, and linkage to regulatory reporting decisions in their complaint record forms.
Feedback System Not Integrated with Complaints
moderateISO 13485 positions complaints within a broader feedback collection system (8.2.1). Many organizations treat complaints and general customer feedback as entirely separate processes, missing the requirement to evaluate all feedback, not just formal complaints, for quality signals.
Evidence signals
- •
FILE_EXISTS
(Complaint|CMPL|Customer.*Feedback|MDR.*Evaluation)
- •
CONTENT_MATCH
Does this document describe procedures for receiving, investigating, and evaluating complaints including MDR reportability assessment and trending?
Audit defense
Complaint handling for [your product] is managed through [your document ID]. Every complaint is logged, investigated, and evaluated for MDR reportability. Quarterly trending analysis feeds our CAPA system, ensuring systemic issues are identified and addressed proactively.