Product Release 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 the formal decision to release finished medical devices for distribution. ISO 13485:2016 clause 8.2.6 requires that product release and service delivery do not proceed until the planned arrangements have been satisfactorily completed, and that the identity of the person authorizing release is recorded.
What's Inside
- Purpose and Release Principles
- Authorized Release Personnel
- PART A — Release Certificate, Lot 1002-27-027
- Lot Identification
- Release Checklist
- Release Decision
- Lot Release Log
- Release Performance
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 7.5.1, 8.2.6 and 8.3. 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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