QMS Framework v1.0
Quality management at every stage
Policies, governance structures, processes, controls, KPIs, and continuous improvement mechanisms ensuring every OPES product, service, and operation consistently meets defined quality objectives.
Quality policy
Seven foundational commitments
Reliable solutions
Delivering reliable and secure healthcare technology solutions.
Patient safety
Patient safety is at the centre of every decision.
Regulatory compliance
Compliance with applicable legal and regulatory frameworks.
Customer satisfaction
Customer satisfaction and adoption as key quality metrics.
Interoperability
Seamless data exchange with partner systems.
Continuous improvement
Ongoing improvement of products and services.
Operational excellence
Efficiency and control of internal operations.
Guiding principles
Six principles guiding every quality decision
Customer focus
Understand and anticipate customer needs as the starting point of every quality effort.
Clinical safety
Protect patients and healthcare professionals in every workflow.
Leadership commitment
Quality is a leadership responsibility — not only the quality team's.
Evidence-based decisions
Drive improvement through measurable, verifiable information.
Process orientation
Manage quality through controlled, documented processes.
Continuous improvement
Quality improvement is an ongoing effort, not a one-time project.
Governance structure
Five committees, one unified quality vision
Quality Management Board
Strategic oversight: quality strategy, objectives, and performance review.
Quality Steering Committee
Quality planning, monitoring, and improvement at the operational level.
Clinical Quality Committee
Clinical quality, patient safety, and clinical audits.
Product Quality Committee
Product standards, release quality, and product reviews.
Service Quality Committee
Implementation quality, support quality, and customer success.
Quality domains
Eight domains governed by the QMS
1
Product quality
Software reliability & performance
Requirements validation
Design reviews
Code reviews
Testing
Release approval
Post-release monitoring
2
Clinical quality
Safe clinical operations
Clinical reviews
Clinical validation
Safety assessments
Incident reviews
3
Implementation quality
Successful deployments
Project reviews
Readiness assessments
Go-live reviews
Post-go-live evaluations
4
Support quality
Effective support services
SLA monitoring
Ticket reviews
Escalation reviews
Customer feedback reviews
5
Information quality
High-quality healthcare information
Data validation
Data quality audits
Duplicate detection
Completeness monitoring
6
Security quality
Secure operations
Security reviews
Vulnerability assessments
Incident reviews
Compliance monitoring
7
Training quality
Effective knowledge transfer
Curriculum reviews
Certification reviews
Training assessments
Competency validation
8
Partner quality
Partner performance management
Partner certification
Partner audits
Performance reviews
Quality lifecycle
Seven stages, no compromises
Plan
Define quality objectives and standards.
Design
Quality-oriented design with integrated reviews.
Build
Development conforming to quality standards.
Validate
Testing, clinical reviews, and release approvals.
Deploy
Production deployment with readiness review.
Monitor
Continuous monitoring of KPIs and quality incidents.
Improve
Corrective and preventive actions, continuous improvement.
Assurance vs control
Prevent and detect
Quality Assurance (QA) — Prevent
Standards development
Process reviews
Audits
Training
Compliance monitoring
Quality Control (QC) — Detect
Testing
Reviews
Inspections
Verification
Corrective & Preventive Action (CAPA)
A structured process for every significant issue
Identification
Issue detected and recorded.
Root cause analysis
Underlying cause identified.
Corrective action
Immediate cause resolved.
Preventive action
Recurrence prevention put in place.
Verification
Effectiveness of actions confirmed.
Closure
Documentation and formal closure.
Quality performance indicators
Measure to improve
Product KPIs
Defect density
Release stability
System availability
Mean time to resolve defects
Clinical KPIs
Documentation completeness
Alert accuracy
Duplicate patient rate
Clinical incident rate
Service KPIs
SLA achievement rate
First contact resolution
Customer satisfaction
Deployment success rate
Training KPIs
Certification pass rate
Training satisfaction score
Competency achievement rate
Quality maturity model
Five levels toward quality excellence
1
Ad Hoc
Unpredictable, reactive processes.
2
Managed
Processes planned and tracked.
3
Defined
Standardised processes.
4
Measured
Quality managed quantitatively.
5
Optimized
Continuous improvement & innovation.
Explore our quality approach?
Contact our team to understand how the OPES QMS framework applies concretely to your deployment and implementation projects.