ISO 13485 Clause 8 Transition Notes
- The QMSR eliminates FDA-specific structure in favor of ISO 13485:2016 clauses. All above ISO 13485 clauses are now explicit requirements under QMSR.
- New documentation and risk-based decision-making are emphasized throughout the QMSR.
- Clause 8.2.3 (Reporting to Regulatory Authorities) under ISO 13485 is aligned with external FDA regs, such as 21 CFR Parts 803 (MDR), 806 (Corrections and Removals), and 1004 (Repurchase/Replacement).
ISO 13485 Clause 8 – Measurement, Analysis, and Improvement
The transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) marks a significant evolution in how medical device manufacturers are expected to approach quality assurance and regulatory compliance.
One of the most critical areas impacted by this transition is Clause 8 of ISO 13485:2016, which focuses on the processes of measurement, analysis, and improvement. This clause aligns with the QMSR’s increased emphasis on risk-based thinking, continuous monitoring, and feedback-driven improvement, making it central to both regulatory compliance and long-term product safety and effectiveness.
Overview of Changes
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Clause 8 integrates a wide range of quality activities that were previously scattered throughout the QSR, including complaint handling, internal audits, product inspections, and corrective/preventive actions. With the adoption of ISO 13485, manufacturers are now required to implement a more structured, data-driven approach to quality system performance and product conformity.
The following table outlines the key mappings between former 21 CFR Part 820 requirements and their ISO 13485 counterparts, highlights new expectations under the QMSR framework, and offers practical insights for aligning your quality management system with the modernized regulatory environment.
| Clause 8 Subclause | Title | Relevant QSR Section(s) | Notes/Key Differences |
|---|---|---|---|
| 8.1 | General | Implicit across Subparts M, N, and O | QSR lacks a single "general" clause; intent is met via CAPA and audit requirements |
| 8.2 | Monitoring and measurement | 820.70(a), 820.72, 820.75, 820.80, 820.250 | Covers monitoring of processes and product, measurement equipment, and data analysis |
| 8.2.1 | Feedback | 820.100(a), 820.198, 820.200, 820.250 | Feedback is not separately defined in QSR, but addressed within complaints and CAPA |
| 8.2.2 (general) | Complaint handling | 820.198 | QSR has a standalone complaint handling section |
| 8.2.3 | Reporting to regulatory authorities | 803 (MDR), 806 (Corrections/Removals), 820.100, 820.198(e) | QSR points to external regs for reporting; ISO 13485 integrates it into QMS |
| 8.2.4 | Internal audit | 820.22 | Direct match; both require documented internal audits |
| 8.2.5 | Monitoring and measurement of processes | 820.70(a), 820.75 | QSR includes requirements for process validation and monitoring |
| 8.2.6 | Monitoring and measurement of product | 820.80, 820.86 | Covers receiving, in-process, final inspection, and acceptance records |
| 8.3 | Control of nonconforming product | 820.90 | Direct mapping |
| 8.3.1 | General | 820.90(a) | Control and segregation required |
| 8.3.2 | Before delivery | 820.80(d), 820.90(a) | Product not meeting specs must be identified and controlled before release |
| 8.3.3 | After delivery | 820.100, 820.198, 820.200 | Managed under complaint handling, servicing, and CAPA |
| 8.3.4 | Rework | 820.90(b)(2) | Rework procedures required and must be documented |
| 8.4 | Analysis of data | 820.100(a)(1), 820.250 | Data analysis explicitly mentioned in both |
| 8.5.1 | Improvement - general | 820.100, 820.75(c) | General improvement intent captured in CAPA and process validation feedback |
| 8.5.2 | Corrective action | 820.100(a) | Strong direct match; ISO may be more prescriptive in documentation |
| 8.5.3 | Preventive action | 820.100(a) | QSR includes it under the same section as corrective action, less emphasis than ISO |