punyam academy
101 posts
Mar 04, 2024
2:32 AM
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While ISO 13485 provides a framework, it doesn’t dictate a specific format for documentation. However, some key documents are essential for demonstrating compliance:
- Quality Manual: This overarching document serves as a roadmap for the QMS, outlining the organization’s quality policy, objectives, and overall approach to meeting ISO 13485 requirements.
- Standard Operating Procedures (SOPs): Detailed instructions outlining specific processes within the QMS, such as risk management, design control, and non-conforming product handling.
- Work Instructions: Step-by-step guides for specific tasks within a process, ensuring consistency and quality in execution.
- Quality Records: Documented evidence of activities performed according to procedures, including design history files, inspection records, and training records.
- Medical Device File: A comprehensive collection of documents related to the design, development, manufacturing, and distribution of a specific medical device.
Documenting for Success: Best Practices in ISO 13485 Compliance
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