Compliance & Certifications
Internationally recognised quality standards, national regulatory registration and a record of recognition from Pakistan’s medical and scientific community.
Our commitment
Healthcare and laboratory supply depends on trust. BACTSYS holds ISO 9001:2015 and ISO 13485 certification and is registered with DRAP and the Karachi Chamber of Commerce & Industry.
These credentials give hospitals, diagnostic laboratories, research institutes and procurement teams a clear, verifiable basis for working with us — from vendor registration and tenders to day-to-day orders.
Certifications & registrations
Certified by Amtivo
Quality Management System
ISO 9001:2015 is the internationally recognised standard for quality management systems. Our certification by Amtivo, an independent certification body, covers how BACTSYS plans, documents and controls its work to meet customer and regulatory requirements.
Medical device quality standard
Medical Devices Quality Management
ISO 13485 sets out quality management requirements specific to organisations in the medical device sector, including those that supply and distribute medical devices. It places particular weight on traceability, record keeping and a risk-based approach to quality.
National regulator
Drug Regulatory Authority of Pakistan
The Drug Regulatory Authority of Pakistan (DRAP) is the national body that regulates medicines and medical devices in Pakistan. BACTSYS is registered with DRAP.
Chamber of commerce
Karachi Chamber of Commerce & Industry
The Karachi Chamber of Commerce & Industry (KCCI) represents the city’s trade and industry community. BACTSYS is registered with KCCI as a Karachi-based business.
Recognition
Awards and appreciation plaques from medical and scientific conferences, presented to BACTSYS and, under its former name, Lucky Lab International.
Vendor registration & tenders
Tell us which documents your procurement team needs and our team will get back to you.
