ISO 13485
QMS Scope Statement
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
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- Standard
- ISO 13485
- Document Type
- Scope
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Scope
This document formally defines the boundaries and applicability of the QMS of your organisation.
What's Inside
- Scope Statement
- Organization and Sites
- Products in Scope
- Activities and Life-Cycle Stages
- Regulatory Roles and Outsourced Processes
- Regulatory Roles
- Outsourced Processes
- Exclusions and Non-Applications
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 4.1 and 4.2.2. 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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