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Chapter 6
Clause 6: Resource Management
Chapter 6 begins by explaining the close alignment between QSR regulations for Organization, Personnel, Production and process controls, and Clause 6, Resource Management.
Chapter contents include:
A table that directly maps QSR requirements to the subclauses of Clause 6, with an impact summary for each.
A narrative clause overview that includes provision of resources, human resources, infrastructure, and work environment and contamination control,
A transition section that covers broadening the scope of “resources,” competence and training enhancements, infrastructure management, and documentation and records.
Content examples for suggested QMS policy and procedures:
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- Resource Management Policy
- SOP – Provision of Resources
- SOP – Human Resources Competence and Training
- SOP – Infrastructure Management
- SOP- Work Environment and Contamination Control
Chapter 6 explains ISO 13485 Clause 6, which defines the resource management requirements needed to operate an effective and compliant Quality Management System under the QMSR. While rooted in familiar QSR expectations, Clause 6 requires a more formalized, documented, and continually reassessed approach to personnel, infrastructure, equipment, and work environments.
The chapter opens with a comparison of QSR §§820.20, 820.25, and 820.70 to their ISO Clause 6 counterparts, showing that although the underlying intent remains consistent, the QMSR introduces more explicit planning requirements and structured documentation.
Under ISO 13485, organizations must determine resource needs proactively, justify them, and reassess them regularly through the PDCA cycle – moving beyond the QSR’s simpler “provide adequate resources” model.
A major focus is competence, which becomes a formal regulatory obligation. Organizations must define competency criteria for each role, evaluate qualifications, provide targeted training, and assess training effectiveness. This replaces the QSR’s training-centric approach with a competency-based model that ensures personnel not only receive training but understand the relevance and consequences of their work.
Resource management also expands to infrastructure, requiring documented maintenance programs for buildings, utilities, equipment, software, and support services. Changes to infrastructure, including IT systems and sterilization contractors, now require documented planning and change control – expectations only loosely implied under the QSR.
The chapter also details enhanced requirements for work environment and contamination control. Organizations must establish and monitor environmental conditions that affect product quality, such as cleanliness, temperature, humidity, gowning, and personnel health. For sterile or implantable devices, risk-based contamination control programs must align with ISO 14644 and ISO 14698, integrating particulate, microbial, and environmental monitoring.
To help manufacturers transition effectively, Chapter 6 outlines how to build competency matrices, infrastructure plans, environmental monitoring systems, and resource-based management review inputs. These tools shift resource management from an operational afterthought to a strategic pillar of the QMS.
The chapter concludes with sample policies and SOPs that translate Clause 6 requirements into practical processes for resource planning, personnel competence, infrastructure maintenance, and contamination control – helping organizations meet QMSR expectations and strengthen ISO 13485 alignment.
