Manage nonconformity easily with MedQdoc’s automated NCs workflows
Nonconformity Management in MedQdoc
A well-defined process for handling nonconformities is a cornerstone of any compliant Quality Management System (QMS). Within MedQdoc, the Nonconformity (NC) module enables structured documentation, risk assessment, corrective actions, and traceability — all aligned with international regulatory requirements.
Workflow for Nonconformity
The MedQdoc Nonconformity workflow guides users through a structured, compliant, and fully traceable process to manage corrective and preventive actions throughout the CAPA lifecycle.
- Registration: Record the nonconformity, affected process or product, and any immediate corrections.
- Risk Assessment: Evaluate impact and severity to determine containment and escalation needs.
- Classification: Categorize as major or minor and decide if CAPA initiation is required.
- Disposition: Decide on the product or process handling (rework, scrap, return, use-as-is, etc.).
- Action Plan & Follow-up: Assign responsibilities, due dates, and verify the effectiveness of corrective actions.
- Review & Closure: Ensure final verification, approval, and closure by authorized personnel.
How it Works
Each step can be saved as a draft or marked as complete to move the workflow forward. Once a step is completed, the Nonconformity automatically transitions to the next defined stage — maintaining structure, compliance, and control. Certain steps may also include a formal review and approval phase, depending on your organization’s configuration.
Key Benefits of MedQdoc
The key benefits of managing nonconformities in MedQdoc are listed below:
- Ensures full traceability between nonconformities, CAPAs, and change records.
- Supports ISO 13485 and FDA QSR/QMSR compliance through structured documentation and approval steps.
- Automated lifecycle transitions help maintain control, accountability, and audit readiness.
- Built-in review and approval stages ensure oversight and validation by responsible roles.
Regulatory Framework
Both ISO 13485:2016 and the U.S. FDA Quality System Regulation (QSR) require manufacturers to establish and maintain documented procedures to manage product or process nonconformities.
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ISO 13485:2016 — Clause 8.3
Requires the organization to identify and control nonconforming products and processes, determine corrective actions, and ensure records of the nature of the nonconformity and any subsequent actions taken are maintained. -
21 CFR Part 820 — Subpart I (QSR) / QMSR 2026
The FDA mandates a documented process for identification, segregation, evaluation, and disposition of nonconforming products, including review and approval by qualified personnel. Under the new QMSR (Quality Management System Regulation), effective February 2026, these requirements are harmonized with ISO 13485:2016.
Purpose of Nonconformity Management
The goal of managing nonconformities is to ensure that any deviation from established requirements — whether related to products, processes, documentation, or services — is identified, evaluated, and resolved systematically. This not only prevents recurrence but also strengthens continuous improvement and compliance.
Case Management Workflows in MedQdoc
Below you can learn more about the predefined Case Management workflows available in MedQdoc. Organizations using PRO+ Custom can also design company-specific case flows tailored to their internal QMS and product scope.
- Change Management
- Nonconformity
- CAPA
- Customer Complaint
- Supplier Management
- Training Management
- Equipment Management
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… and discover how our Case Management workflows help you stay compliant and efficient.
Designed by medical device quality and regulatory compliance experts.
Includes over 160 QMS and MDR/IVDR technical documentation templates for medical device compliance.
Intuitive and user friendly; simple and effective ISO 13485 document control.
MedQdoc is loved by auditors.
“One of the top reasons we chose the system was because it was created by regulatory experts, which seems to be unique in the market.” Malin Nilsson, CEO, Inossia
MedQdoc has extensive functionality in all of the QMS areas below, please talk to the MedQdoc team for specific queries that you may have:
MedQdoc is used across the medical device industry
