QMS & Quality Policy
Discover the Quality Control System, objectives, policies, and continuous improvement loops guiding Mecca Healthcare (MHPL) toward zero-defect operations.
“Manufacturing Products is a Responsibility”
MHPL's Total Quality Control System consists of chemical, physical and biological control systems from basic monomer to finished products, and in-process quality control checks at every production cycle.
Our Policy Aims
- Aims to build-up confidence among the consumers by providing world class quality products.
- Focuses on acquiring best raw material from the suppliers.
- Encourages team work by proper training of manpower and complying with ISO 9001:2015 & ISO 13485:2016 standard requirements.
- Encourages the organisation to be committed towards 'constant innovation' (both product and process).
Process-Based Quality Management System
Visualizing the circular flow of resource planning, product realization, and measurement parameters driving continual QMS improvement.
*Continually improving the Quality Management System effectiveness in compliance with international ISO and WHO-GMP norms.
Concept of Quality Assurance
For us, Quality Assurance is a concept that **begins before any product is produced**, is present **during all phases of production**, and remains active **after production** till final testing is complete.
Adequate Process Control
We believe the intent of the **Quality Assurance System** is to assure that adequate control is maintained throughout the manufacturing process.
Every material compound, extrusion parameter, assembly step, and sterilization batch is backed by systematic audit logs to eliminate structural defects and ensure clinician trust.
Quality Control Department Pipeline
Visualizing the sequential phases and audit actions executed systematically by our quality controllers.
Conceptualize
Define quality goals, target specifications, and standard benchmarks conforming to global regulatory and customer requirements.
Plan
Plan testing protocols, raw material checking standards, cleanroom compliance scripts, and laboratory validations.
Develop
Develop advanced compounding controls, physical test jigs, tooling validations, and certified cleanroom molding assemblies.
Co-ordinate
Coordinate cross-department quality audits, supervisor checklists, raw materials screening, and staff hygienic training.
Implement
Implement 100% inline physical leak checks under pressure/vacuum, particulate counters, and cleanroom air volume HVAC controls.
Inspect
Inspect compound batches for bioburden levels, test final products for pyrogens and absolute sterility, and release certificates.
GMP Principles for QMS
We continuously strive to improve QMS effectiveness by aiming for core GMP principles.
Stakeholders' Commitment & Customer Feedback
Constant dialogue with users, doctors, and distributors.
Supplier Management
Rigorous vetting and sourcing of medical-grade PVC polymers.
TQC (Total Quality Control)
Chemical, physical, and biological checks at every cycle.
Benchmarking
Establishing strict internal standards surpassing standard guidelines.
Awards & Awareness
Encouraging a zero-defect quality mindset across all ranks.
5S System
Systematic workplace cleanliness, order, and standardized safety.
Kaizen
Continuous minor and major improvements to daily processes.
Quality Objectives & System Planning
How Mecca Healthcare structures operational goals and ISO-certified execution frameworks to eliminate process variation and secure zero-defect clinical reliability.
Quality Objectives
QMS Integrity & Policy
Core BenchmarkAchieve zero-compromise quality standards by maintaining the end-to-end integrity of our Quality Management System across all operations.
Dual ISO Compliance
ISO 13485 & 9001Continual improvement and verifiable compliance adhering to both ISO 13485:2016 (Medical Devices) and ISO 9001:2015 global requirements.
Controlled Facilities & Staff
Class 10,000 CleanroomRigorous management of manufacturing facilities, cleanroom processes, and certified personnel to cost-effectively fulfill regulatory and customer needs.
Zero-Defect & Waste Elimination
Lean KaizenContinuous process optimization by emphasizing reduction of part-to-part variation and the systematic elimination of operational waste.
QMS Planning Framework
Process Identification
Identify and map all required clinical, production, and quality control processes across the organization.
Sequence & Interaction
Define the operational sequence, inputs/outputs, and interdepartmental handoffs from compounding to final packaging.
Criteria & Methods
Establish strict in-line inspection criteria, calibration standards, and leak-testing methods to ensure tight control.
Resource Deployment
Ensure continuous availability of validated cleanroom machinery, instrumentation, documentation, and expert operators.
Monitoring & Analytics
Continuous bioburden testing, statistical defect tracking, environmental HVAC monitoring, and quality data audits.
Continual CAPA Loops
Execute targeted corrective and preventive actions (CAPA) to realize planned goals and sustain quality evolution.
Audit & Review Loops
Internal audits and executive reviews proactively inspect system health and integrate standard adjustments.
Resource Readiness
Strategic acquisition of precision inspection tooling, cleanroom fixtures, and technical manpower capabilities.
Three Inter-related Sub-elements
Our process-based QMS emphasizes Facilities, Personnel, and Processes to ensure consistent clinical outputs.
Management Commitment
Focused towards customer support, leadership, involvement of people, process-based approach, continual improvement, factual decision making, and mutually beneficial supplier relationships.
Resource Management
Effective fulfillment of customer needs by organizing state-of-the-art manufacturing plants, machinery, cleanroom assembly units, and highly trained personnel.
Measurement & Improvement
Continuous inspection of production cycles in accordance with regulatory guidelines and pharmacopoeias to secure uniform device quality.
Strict Bioburden & Bio-Compatibility Validation
Our Quality Control system is backed by fully equipped chemical, physical, and microbiology laboratories inside each manufacturing plant. We execute continuous testing of raw polymers, cleanroom environment compliance, and post-sterilization documentation release.