Quality Assurance

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Quality Assurance

Our single most important objective is to produce consistent quality products, safe and effective. The factory is equipped with a team of experienced and qualified process engineers and technologists to continuously upgrade the machinery, manufacturing processes and the latex formulation in order to achieve the quality objectives.

With a comprehensive Quality System like ISO 13485, we are constantly being audited internally and by third party certification bodies to ensure our products meet customers’ expectations and requirements.

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Market

NRS Global Partners Sdn Bhd has footprints worldwide.

Our customer base:

Worldwide

Our business base:

Commercial markets

Non-commercial markets

Government tenders

Novelty markets

Our product range:

One of the most varied ranges available in this market.

Meeting Standards & Certifications

Management System:

ISO 13485 / EN ISO 13485

ISO 14001

MDA Establishment License

Meeting Standards:

ISO 4074 / EN ISO 4074

WHO 2010

ASTM D3492

Regulatory Approval or Marketing Clearance:

CE Mark

China NMPA (National Medical Products Administration)

SABS Certificate Mark

Canadian Medical Device License

Medicines Control Authority of Zimbabwe

Korea MFDS

Tanzania TBS Mark

Brazil GMP

USA 510k Notification for Male Latex Condom and Lubricating Jelly

Ghana GMP

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Pre-Shipment Control Parameters

Visible Defects

Dimension Control

Freedom from Holes

Air Burst Volume and Pressure (Aged and Unaged)

Tensile Test (Aged & Unaged)

Lubricant Quantity Measurement

Colour Fastness for Coloured Condoms

Package Integrity Test

Packaging & Labelling

Visibly Open Seals