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Red Witch Wiki

Welcome to the Red Witch Wiki, the central hub for documentation, quality management, compliance, and project planning for Floating Eye Software (FLEY) and the Red Witch pilot project.

This wiki organizes all controlled documentation for team members, auditors, and stakeholders, including:

• QMS authoring and operations (Quality Manual, Policy, SOPs, WIs)
• Project documentation for Red Witch
• Compliance standards and frameworks
• Plans and templates for implementation and improvement

Use this page as your starting point to navigate FLEY’s Quality Management System (QMS) and Red Witch project documentation.

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1. Quality Management System (QMS)

FLEY’s QMS is built around ISO 9001:2015 and ISO 9001:2024 (Climate Action Amendment) principles, emphasizing risk-based thinking, PDCA, and continual improvement.

Core QMS Documents

• Quality Manual – Overview of FLEY’s QMS framework and scope.
• Quality Policy – Organizational quality commitments and objectives.
• Context Analysis – Internal/external issues and interested parties.
• Organizational Chart – Roles, responsibilities, and authorities.
• Process Map – Process interactions and workflow visualization.
• Risk Register – Centralized record of QMS and project risks.
• QMS Coverage – Matrix of ISO clauses and corresponding QMS documents.

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Standard Operating Procedures (SOPs)

• Document Control SOP
• Change Control SOP
• Design Control SOP
• Identification and Traceability SOP
• Leadership SOP
• Management Review SOP
• Project Management SOP
• Quality Planning SOP
• Risk and Opportunity Management SOP

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Work Instructions (WIs)

GitHub Operational WIs

• GitHub QMS Setup
• GitHub QMS Overview
• GitHub QMS Operations
• GitHub Document Control
• GitHub Project Management
• GitHub Change Control
• GitHub Continuous Improvement
• GitHub Version Control

FLEY-Specific WIs

• FLEY Design Control WI

Information Security & Standards

• Information Security – Based on NIST guidelines.

Ontario Design Framework

• Ontario Design Framework – Overview of the Ontario Service Design Framework.
• Ontario Service Design WI – Implementation work instruction.

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Templates

• Standard Operating Procedure Template
• Work Instruction Template
• Quality Plan Template
• Project Quality Plan Template
• Design Control Plan Template
• Design Output Template
• DCP Template Ontario DSS
• Header Template

Tip: Start with the Quality Manual for a complete overview of the QMS structure and document hierarchy.

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2. Red Witch Project Documentation

All documentation specific to the Red Witch pilot project.

• Red Witch Master Document List – Index linking all Red Witch documents.
• Red Witch Quality Plan – Project-specific quality and compliance plan.
• Red Witch Privacy – Privacy and ethical data handling approach.
• Red Witch Accessibility – Accessibility requirements and standards.
• Red Witch Users – Personas and user analysis.
• Red Witch Requirements – Functional and non-functional specifications.
• Red Witch Software Architecture – System and module overview.
• Red Witch Roadmap – Development milestones and release planning.
• Red Witch Risk Management – Risk identification and mitigation.
• Red Witch Post-Market Surveillance – Monitoring, feedback, and CAPA process.
• Red Witch Market Analysis – Market and competitive assessment.
• Red Witch Market Comparison – Comparative insights.
• Red Witch Peer Review – Expert and internal review documentation.

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3. Planning & Continuous Improvement

Planning, improvement, and monitoring resources.

• Continuous Improvement Plan – Continuous improvement framework and KPIs.
• Red Witch Pilot SOP Plan – SOP authoring, pilot testing, and validation.
• Repo Migration Plan – Migration and repository transition strategy.
• Red Witch Quality Plan – Repeated link for quick access.
• Templates: Project Quality Plan Template, Quality Plan Template

Track operational issues, risks, and improvements in the FLEY QMS Kanban Board.

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4. Compliance Standards

Compliance references tracked internally for audit readiness.

• Compliance Index – Index of all regulatory and quality standards.
• 21 CFR 820 – FDA Quality System Regulation.
• ISO 13485 – Medical device quality management.
• ISO 14971 – Risk management for medical devices.
• ISO 9001 – Quality management systems (core QMS alignment).
• ISO 9004 – Quality management for sustained success.
• IEC 62304 – Medical device software lifecycle.
• Ontario DSS – Ontario Digital Service Standard compliance.

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5. Governance and Usage

• Use this wiki for official QMS and Red Witch documentation.
• All SOPs and WIs are version-controlled and linked to GitHub Issues for traceability.
• Compliance and project pages reference controlled documents for audits.
• Always start from the Quality Manual or Red Witch Master Document List when onboarding or preparing for review.
• Updates, changes, and CAPA are tracked through Issues linked to the FLEY QMS project board.