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-Sec6: Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)

ISO 13485:2016 Section 6 (Resource Management) incorporated via §820.10. ELEMENTS: (6.1) PROVISION OF RESOURCES - determine + provide resources needed for the QMS + product realization; (6.2) HUMAN RESOURCES - competence + training + awareness; personnel performing work affecting product quality must be competent on the basis of education + training + skills + experience; documented procedures for establishing competence + training needs + providing training + evaluating effectiveness of actions; awareness records; (6.3) INFRASTRUCTURE - buildings + workspace + utilities + process equipment + supporting services; maintenance activities to prevent product / process risks; (6.4) WORK ENVIRONMENT + CONTAMINATION CONTROL - work environment requirements documented per product / process; planned controls for environment-sensitive products; contamination control including personnel cleanliness + clothing + handling procedures; pest control + cleaning programmes. FDA QMSR-specific note: §820.15 clarifies that 'work environment' includes COMPUTER SYSTEM environment - computer system validation under Part 11 + cybersecurity controls.

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

What else in your programme already covers this

This control maps to 22 controls across 12 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

21 CFR Part 211 - Current Good Manufacturing Practice · 3 controls

SWIFT CSCF · 3 controls

  • SWIFTCSCF-3 Physically Secure the Environment (Objective 3)
  • SWIFTCSCF-4 Prevent Compromise of Credentials (Objective 4)
  • SWIFTCSCF-7 Plan Incident Response (Objective 7)

GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6 · 2 controls

  • GGAP-IFA-AllFarmBase-Mgmt-Workers-Env-Trace GLOBALG.A.P. IFA v6 All Farm Base (AF): Management, Workers, Environment, Traceability and Food Safety
  • GGAP-IFA-CropsBase-Production-PPP-IPM GLOBALG.A.P. IFA v6 Crops Base (CB): Propagation, Soil, Water, IPM, PPP, Fertilizer and Harvest

GS1 Global Standards - Supply Chain Traceability and Data Security · 2 controls

PCI DSS 4.0 · 2 controls

  • 2.1.1 2.1.1 Requirement 2 policies and procedures governed
  • 2.1.2 2.1.2 Requirement 2 roles and responsibilities assigned

21 CFR Part 58 - Good Laboratory Practice (GLP) · 1 control

  • 58.49 Laboratory Operation Areas

FDA 21 CFR Part 11 · 1 control

  • Part11.CSV Computer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)

FSSC 22000 - Food Safety System Certification · 1 control

  • FSSC-Additional-Requirements-v6 FSSC 22000 Additional Requirements v6 (Food Defense + Food Fraud + Allergen + Environmental + Culture)

ICH E6(R3) - Good Clinical Practice · 1 control

IEC 62304:2015 Medical Device Software Lifecycle Processes · 1 control

  • IEC62304-5.1 Software Development Planning

SQF Code Edition 9 - Safe Quality Food · 1 control

  • 2.1.3 Food Safety and Quality Culture

Singapore AI Governance Framework · 1 control

  • AIGF-3.3 Repeatability and Traceability

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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MCP endpointAll FDA Quality Management System Regulation (QMSR) controls