Acceptance Criteria
Defined conditions that a product, change, or process must meet to be approved or released.
Audit (Internal)
An internal examination of processes, documentation, and compliance to verify adherence to standards and internal procedures.
Audit (External / Third-Party)
An independent assessment conducted by customers, regulators, or certification bodies.
Audit Trail
Tamper-evident, chronological records showing who performed what action, when, where, and why — essential for regulatory compliance.
CAPA (Corrective and Preventive Action)
Structured investigation of root causes with actions to correct existing issues and prevent recurrence.
Change Control
A formalized process for assessing, approving, implementing, and verifying changes to documents, processes, or products.
Closed-Loop Quality
A continuous system where issues, actions, verifications, and monitoring are interconnected to ensure permanent resolution.
Complaint Management
Structured capture, investigation, classification, and resolution of customer product issues.
Conformance / Nonconformance (NC)
Meeting or failing to meet specified requirements; NCs require documented investigation and disposition.
Deviation
A temporary or unplanned departure from an approved process or specification.
Document Control
Centralized management of controlled documents through creation, approval, versioning, training, and retirement.
DMR (Device Master Record)
The complete, approved set of instructions and specifications for producing a medical device.
DHF (Design History File)
Evidence that a device was designed according to approved procedures and regulatory expectations.
DHR / eDHR (Device History Record)
Documentation showing how each unit or batch was manufactured, inspected, and released.
eBR (Electronic Batch Record)
Real-time, automated capture of batch production data for complete traceability.
Effectiveness Check
Verification that corrective/preventive actions are working as intended.
GxP (Good Practice Regulations)
Umbrella term including GMP, GCP, GLP, GDP, etc., governing quality and safety in regulated industries.
ISO 9001
Standard defining QMS requirements for organizations across industries.
ISO 13485
Standard defining QMS requirements specific to medical device manufacturers.
MIR (Medical Incident Report)
Mandatory reporting of device-related adverse events in the EU.
eMDR (Electronic Medical Device Report)
Electronic submission of device adverse events to the FDA.
Notified Body (NB)
EU-designated organization authorized to assess product conformity (e.g., for CE marking).
CE Marking
Indicates conformity with EU safety and performance requirements.
Periodic Review
Scheduled evaluation of documents, suppliers, risks, and processes for ongoing accuracy and compliance.
Process Owner
The individual accountable for documentation, performance, metrics, and continual improvement of a defined process.
Quality Assurance (QA)
Planned activities ensuring processes consistently produce compliant results.
Quality Control (QC)
Operational inspection/testing to verify product quality.
QMS (Quality Management System)
Structured framework of processes, controls, and responsibilities that ensure product quality and compliance.
QSR (Quality System Regulation)
FDA-required QMS framework for medical devices (21 CFR Part 820).
Risk Management File (RMF)
Comprehensive record of risk assessments, mitigations, and controls maintained throughout a product’s life.
Supplier Quality Management
Processes ensuring suppliers meet specification, compliance, and performance requirements.
Training & Competency Management
Ensuring personnel have the required knowledge, skills, and documented training.
URS (User Requirements Specification)
Document describing what the user needs the system to accomplish.
Validation (Process)
Providing evidence that a process consistently produces results meeting predetermined specifications.
Verification
Confirmation that requirements have been met (e.g., testing, inspection).
Workflow Automation
Digital routing, approvals, and escalations that enforce consistency and reduce human error.
