Production Batch 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 is the Device History Record (DHR) for one production lot. ISO 13485:2016 clause 7.5.1 requires your organisation to establish and maintain a record for each medical device or batch that provides traceability to the extent specified in clause 7.5.9 and identifies the amount manufactured and the amount approved for distribution.
What's Inside
- How to complete it
- Lot Identification
- Materials Issued (Traceability, 7.5.9)
- Line Clearance and Start-Up
- Manufacturing Steps
- In-Process Inspection
- Sterilisation
- Final Inspection
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 7.5.1 and 7.5.9. 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
Reviews
There are no reviews yet.