Root Cause Analysis Record
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
- Records
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Records
This record documents how the cause of a nonconformity was determined. ISO 13485:2016 clause 8.5.2 b) requires your organisation to determine the causes of nonconformities before planning corrective action, and clause 8.4 requires appropriate data, including statistical techniques, to be used.
What's Inside
- Purpose and Method
- Team and Timeline
- Problem Definition
- Data Collected
- Complaint Sample
- In-house Reject Trend — HS-01 Channel Rejects
- Possible Causes (Cause-and-Effect)
- Hypothesis Testing
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 8.4 and 8.5.2. 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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