Competency Matrix
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
- Standard
- ISO 13485
- Document Type
- Matrix
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Matrix, Medical Devices
This matrix defines the competence required for each role in the your organisation QMS and shows the current competence of each person against it. It meets ISO 13485:2016 clause 6.2 (a), which requires your organisation to determine the necessary competence of personnel performing work affecting product quality, on the basis of appropriate education, training, skills and experience.
What's Inside
- Competence Level Scale
- Role Requirements — Education, Experience and Qualifications
- Role Competency Matrix — Required Levels
- Individual Competency Status
- Critical Task Cover
- Gap Summary and Actions
- Review and Approval
- Review and sign-off section
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 6.1 and 6.2. It fits with the rest of the QEHS Vault ISO 13485 document set.
Format
Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.
Key Benefits
- Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements
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