QM-001 - Quality Manual
Global
QMS
v1.0
Pending
QM-001 Quality Manual
Purpose
Define the Quality Management System (QMS) for design, development, validation, release, and post-market support of two medical devices.
Scope
- Device 1 digital health software system
- Device 2 digital health software system
- Supporting cloud services, integrations, and quality records
Regulatory Framework
- ISO 13485:2016
- ISO 14971:2019
- IEC 62304:2006 + A1:2015
Quality Objectives
- Maintain document control and revision traceability for 100 percent of controlled records.
- Close CAPA within approved due dates.
- Complete internal audits and management review at planned intervals.
Management Responsibility
- Executive Sponsor approves quality policy and resources.
- Quality Manager owns QMS effectiveness and audit readiness.
Record Retention
- Retain quality records for product lifetime plus five years.