FDA Quality Management System Regulation (QMSR)
QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)

FDA Quality Management System Regulation (QMSR) QMSR-ISO13485-Sec8: Measurement, analysis and improvement (ISO 13485:2016 Section 8)

ISO 13485:2016 Section 8 - the MEASUREMENT + ANALYSIS + IMPROVEMENT framework. (8.1) GENERAL - planning + monitoring + measurement + analysis + improvement processes; (8.2) MONITORING + MEASUREMENT (8.2.1 FEEDBACK from production + post-production + complaint handling; 8.2.2 COMPLAINT HANDLING; 8.2.3 REPORTING TO REGULATORY AUTHORITIES; 8.2.4 INTERNAL AUDIT; 8.2.5 MONITORING + MEASUREMENT OF PROCESSES; 8.2.6 MONITORING + MEASUREMENT OF PRODUCT); (8.3) CONTROL OF NONCONFORMING PRODUCT - identification + documentation + segregation + evaluation + disposition + records; corrective actions where nonconforming product is detected after delivery (CORRECTIONS AND REMOVALS); (8.4) ANALYSIS OF DATA - feedback + customer satisfaction + product conformity + process performance + suppliers + improvement opportunities + outcomes; (8.5) IMPROVEMENT (8.5.1 GENERAL; 8.5.2 CORRECTIVE ACTION - identify cause + evaluate need + determine + implement + verify - the CAPA Corrective Action; 8.5.3 PREVENTIVE ACTION - the CAPA Preventive Action). The CAPA system under §8.5.2 + 8.5.3 is the central improvement mechanism + the most-inspected area in FDA medical-device audits.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 27 controls across 20 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

IATF 16949:2016 - Quality Management System for Automotive Production · 2 controls

  • IATF16949-Clause10-Improvement-Nonconformity-CorrectiveAction-Problem-ErrorProof IATF 16949 Clause 10 - Improvement + Nonconformity + Corrective Action + Problem Solving + Error Proofing + Continual Improvement
  • IATF16949-Clause4-Context-Scope-CustomerSpecific-ProductSafety IATF 16949 Clause 4 - Context of Organization + QMS Scope + Customer Specific Requirements + Product Safety

ICH E6(R3) - Good Clinical Practice · 2 controls

IEC 62304:2015 Medical Device Software Lifecycle Processes · 2 controls

  • IEC62304-4.1 Quality Management System
  • IEC62304-9.6 Analyze Problems for Trends

NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production · 2 controls

  • AQAP2110-7 Production, Special Processes, Inspection, Testing, and Records
  • AQAP2110-8 Internal Audit, Management Review, Corrective Action, CofC, and Continual Improvement

SWIFT CSCF · 2 controls

  • SWIFTCSCF-1 Restrict Internet Access and Protect Critical Systems (Objective 1)
  • SWIFTCSCF-3 Physically Secure the Environment (Objective 3)

AS9100D - Aerospace Quality Management System · 1 control

  • AS9100D-10.2 Nonconformity and Corrective Action

Aged Care Quality Standards 2019 (repealed edition) · 1 control

  • ACQS-8-3 Continuous Improvement

DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition) · 1 control

  • DIQ-2 Data Quality Management

EASA Part-IS - Information Security in Aviation · 1 control

  • IS.AR.210 Findings and Corrective Actions

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) · 1 control

  • IVDR-Art.78 Post-market surveillance plan and system (Article 78)

EU Medical Devices Regulation (MDR 2017/745) · 1 control

  • MDR-Art.83 Post-market surveillance system of the manufacturer (Article 83)

GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6 · 1 control

  • GGAP-IFA-AllFarmBase-Mgmt-Workers-Env-Trace GLOBALG.A.P. IFA v6 All Farm Base (AF): Management, Workers, Environment, Traceability and Food Safety

ICAO Annex 17 - Aviation Security (AVSEC) · 1 control

  • ICAO-ANX17-Chap3-QualityControl-Audits-Inspections-Tests-Certification-Training ICAO Annex 17 Chapter 3 - National Quality Control Programme + Audits + Inspections + Tests + Surveys + Certification + Aviation Security Training Programme (ASTP)

ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions) · 1 control

IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.4) · 1 control

  • IMO-MSC-FAL-Recover-BackupRestore-ContinuityOfNavigation-LessonsLearned-Drills IMO MSC-FAL Recover Function - Backup and Restore + Continuity of Navigation + Continuity of Cargo Operations + Continuity of Propulsion + Lessons Learned + Drills + Resilience

ISO/IEC 27014:2020 · 1 control

  • 27014-5.6 Continuous improvement

NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems · 1 control

  • NISTSP34-5 Plan Testing, Training, and Exercises (TTE)

SQF Code Edition 9 - Safe Quality Food · 1 control

  • 2.5.2 Verification Activities

South Korea ISMS-P · 1 control

  • ISMSP-MS-04 Management Review and Improvement

Voluntary Principles on Security and Human Rights (VPs) · 1 control

  • VPSHR-3 Implementation Guidance and Reporting

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.

Other controls in QMSR: Quality Management System Requirements (§820.10 incorporating ISO 13485:2016 Sec. 4-8)

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