Floating Eye Software Quality Management System (FLEY QMS)

Slug: QMS-Index
Revision: r1
Effective Date: 2025-10-28
Controlled Source: https://github.com/Floating-Eye-Software/fley-qms/blob/main/README.md

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Welcome to the FLEY QMS, the central documentation and compliance management system for Floating Eye Software (FLEY) and its projects, including the original Red Witch pilot project.

This repository serves as the single source of truth for all controlled documentation — including policies, procedures, work instructions, plans, and compliance records.

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1. Quality Management System (QMS)

The FLEY QMS is aligned with ISO 9001:2015 and ISO 9001:2024 (Climate Action Amendment) principles, emphasizing risk-based thinking, process control, and continual improvement.

Core QMS Documents

• Quality Manual
• Quality Policy
• Context Analysis
• Organizational Chart
• Process Map

Start here: Review the Quality Manual for a complete overview of the QMS structure, scope, and document hierarchy.

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

FLEY-Specific WIs

• FLEY Design Control WI
• FLEY Action Management

Ontario Design Framework

• Ontario Design Framework
• Ontario Service Design WI

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Templates

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

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2. Planning and Continuous Improvement

• Continuous Improvement Plan
• QMS Design Control Plan
• Red Witch Pilot SOP Plan
• Repo Migration Plan

The QMS also manages planning, risk, and improvement activities for all FLEY projects.

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3. Compliance Standards

The FLEY QMS maintains a central register of applicable standards and regulatory frameworks.

• Compliance Index
• ISO 9001

Additional standards (ISO 13485, ISO 14971, IEC 62304, etc.) will be added as mappings are developed.

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4. Governance and Usage

• The FLEY QMS is the authoritative system of record for all controlled documentation.
• Each controlled document is versioned, approved, and traceable through GitHub commits, Issues, and PRs.
• QMS artifacts, compliance evidence, and CAPA records are maintained in this repository.
• To onboard or prepare for an audit, begin with the Quality Manual.

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Repository Structure

Compliance/      → Standards and regulatory references
Plans/           → Quality and project planning documents
QMS/             → Core QMS framework and context documents
Records/         → Controlled evidence outputs
SOPs/            → Standard Operating Procedures
Templates/       → Controlled templates for documents and records
WIs/             → Work Instructions by area or system

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Originally developed for the Red Witch pilot project, the FLEY QMS now supports all future Floating Eye Software projects and serves as the foundation for scalable, compliant quality management.