MEDICAL DEVICES CALIBRATION
1. Discharge Equipment/ Devices
- Suction Pump
- Flow meter with Humidifier
- Pressure Gauge of Oxygen Cylinder
- BP Apparatus (Sphygmomanometer)
- Nebulizer (Electric)
- Syringe Pump
- Infusion Pump
- Enteral Feeding Pump
- CPAP
- BiPAP
- Boyles Apparatus
- Anesthesia Machine
- Others
2. Patient Conditioning/ Maintenance
- Incubator
- Autoclave
- Defibrillator
- Ventilator
- Electro Surgical Unit/ Diathermy Machine/ Cautry Machine.
- External Pace Maker
- Electronic Tourniquet
- Dialysis Machine
- Heart Lung Machine
- Patient Warmer
- OT Table
- Radiant Warmer
- Irradiance Meter
- Phototherapy Unit
- Others
3. Monitoring Unit
- Patient Monitors
- Apnea Monitors
- Fetal Monitor
- Therapeutic Stimulator
- Weighing Scale
- Hematology Analyser
- Others
4. Imaging/ Plotters
- Trans illuminator light source
- EEG
- Fetal Doppler
- ECG
- X-Ray Diagnostic Equipment
- Others
5. Medical Device Analyzer/ Simulator Equipment
- Electrical Safety Analyzer
- Infusion Device Analyzer
- Incubator Analyzer
- Defibrillator Analyzer
- Gas Flow Analyzer
- Electro Surgical Analyzer
- Vital Sign Simulator
- Patient Monitor Simulator
- Others
6. Miscellaneous
Any Query/ Get A Quote
Benefit of ISO 9001:2015 Certification:
• ISO 9001 helps Organisation to produce Desired Outcome.
• ISO 9001 ensures Ongoing Controls. ISO 9001 Enhance Customer Satisfaction by meeting Customer requirement.
• Continual Improvement through ISO 9001. Process through PDCA (plan Do Check Act).
• QMS Certification also help to Increase Profitability.
• ISO 9001 help organization for avoidance of Risk. QMS is Sustainable Approach of any Business.
• ISO 9001 Help Business, Government & Society.
Organizations will get certified to this standard in order to demonstrate their ability to consistently provide products and services that meet customer, statutory and regulatory requirements. Certification is granted by accredited certification bodies (registrars) that will audit an organization at planned intervals to confirm conformance to the ISO 9001:2015 standard.
The standard can be applied to any organization. Its benefits include enhanced customer satisfaction, standardized processes, improved quality of products and services, and a culture of continuous improvement.
Role of consultant
• Awareness Training to personnel on ISO 9001
• Training on Internal Quality Auditor
• Documentation like SOP, Quality Manual
• Conducting Internal Audit
• Assisting organization throughout in the certification process
We provide ISO 9001: 2015 certification consultancy in all over India and abroad countries.
Documents Required for MEDICAL DEVICES CALIBRATION
Quality Policy
Internal Audit Reports
Quality Objectives
Corrective and Preventive Action Records
Quality Manual
Management Review Records
Organizational Structure and Responsibilities
Supplier Evaluation Recordss
Procedures and Work Instructions
Training Records
Records and Forms
Customer Complaint Records
Why KSP Solutions for ISO 9001:2015 ISO Certification?
At KSP SOLUTIONS & ASSESSMENT PVT.LTD. committed to offering first class types of assistance to our clients, and our ISO 9001 Quality Confirmation Declaration Administration is no exemption. We grasp the significance of value the executives frameworks in the present serious market, and that is the reason we give a far reaching ISO Quality Administration Testament Supplier administration to our clients.
Our ISO 9001 Quality Affirmation Testament Administration is intended to assist associations with accomplishing the ISO 9001:2015-Quality Administration Framework Authentication Administration, which is a globally perceived norm for quality administration frameworks. Our group of specialists will work intimately with you to grasp your association’s interesting requirements and give fitted answers for address those issues.