ISO 13485 Clause 6 – Resource Management
Like other QSR-to-QMSR transition themes, there is a close alignment between 21 CFR 820.20(b), 820.25, and 820.70 ISO 13485 Clause 6 in their subjects of resources, personnel, training and documentation, awareness of work impact, infrastructure, work environment, and process control.
And like other transition themes, the QSR requirements are generally addressed in the QMSR with the addition of planning/determination, risk management, continuous improvement through ongoing evaluation, and structured documentation requirements. A general comparison of the QSR and QMSR requirements follows.
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| Topic | QSR (21 CFR 820.20) | QMSR (ISO 13485:2016 Clause 6 / QMSR) | Comments |
|---|---|---|---|
| Resources (general) | 820.20(b) requires management to provide resources. | 6.1 says the organization must determine and provide resources. | Adds "determine," indicating a requirement for planning. |
| Personnel | 820.25: focuses on education, background, training, experience. | 6.2: emphasizes competency (education, training, skills, experience) and ongoing evaluation. | Adds more structure around competency, evaluation, and continual reassessment. Ongoing evaluation is added for a PDCA continuous improvement method. |
| Awareness of Work Impact | 820.25 requires training to include consequences of improper performance. | 6.2 requires personnel to be aware of relevance and importance of their work. | Wording is broader but leads to the same expectation. |
| Infrastructure | 820.70 covers some infrastructure needs indirectly through production controls. | 6.3 explicitly calls out infrastructure (buildings, utilities, process equipment). | More explicit and better organized. |
| Work Environment | 820.70 again (indirect) environment must be controlled as necessary. | 6.4 explicitly states work environment must be determined and maintained. | Adds determination (planning) element and is more deliberate and organized in the requirement. |
| Process Control | 820.70 extensively covers control of production and processes. | QMSR splits this between 6.3/6.4 (Resource Management) and 7 (Product Realization). | Organizes QSR information into different sections. |