Process Validation Plan
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
- Plan
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Plan
A Process Validation Plan template for validating a special process whose output cannot be fully verified afterwards, as required by ISO 13485:2016, Clause 7.5.6. It covers the process description and parameters, process risk assessment, validation strategy, installation, operational and performance qualification (IQ/OQ/PQ), test method validation, acceptance criteria and revalidation triggers, with a completed worked example (RF welding with 100% leak testing).
What's Inside
- Process Description and Parameters
- Process Risk Assessment
- Validation Strategy
- Installation Qualification (IQ)
- Test Method Validation (TMV)
- Software Validation — LT-01
- Operational Qualification (OQ)
- Performance Qualification (PQ)
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.5.6. 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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