ISO 9001:2015
Quality management system
Covers how the manufacturing process is documented, controlled and audited.
Watermarked copy as published by the company.
Compliance
What certifications apply to Dzire Surgical India products?
Dzire Surgical India works to ISO 9001:2015, ISO 13485:2016, WHO-GMP and CE requirements, and holds an IEC registration for export from India. Watermarked copies of all five certificates can be viewed and downloaded on this page. Dzire Surgical India Pvt Ltd is a manufacturer and exporter of disposable surgical and medical consumables, established in 2014 in Surat, Gujarat, India.
Publication policy
The watermarked certificate copies published by the company are available to view and download below. Certificate numbers and validity dates are deliberately not typed out on this page until the current documents are re-verified; unwatermarked copies are issued directly to buyers during the enquiry process.
Which standards apply, and can the certificates be seen?
ISO 13485:2016
Medical device quality management system
Sector-specific standard for manufacturers of medical devices, including single-use consumables.
Watermarked copy as published by the company.
WHO-GMP
Good manufacturing practice
Practice standard for premises, process hygiene, batch control and record keeping at the manufacturing site.
Watermarked copy as published by the company.
CE marking
European conformity, applicable device classes
Required for placing applicable devices on the European market; scope depends on the product and its classification.
Watermarked copy as published by the company.
IEC certificate
Importer-Exporter Code, DGFT India
Registration that permits the company to export from India; quoted on export documentation.
Watermarked copy as published by the company.
Need the unwatermarked set?
Clean certificate copies, the declaration of conformity for your SKU and a recent batch test report are issued with the quotation. State the destination country so the correct document set is attached.
Downloads
Company brochure and product flyer
15 pages · A4 landscape · PDF
Company brochure
Company profile, manufacturing scope and the full disposable range with product photography — the document to circulate internally with a procurement or import proposal.
Name and email required — the file opens immediately after.
4 pages · A4 portrait · PDF
Product flyer
Condensed range sheet covering protective wear, wound care, ward consumables and orthopaedic items. Useful as an attachment on a first enquiry.
Name and email required — the file opens immediately after.
How to verify a supplier's certification
- 1Ask for the certificate scan, not a badge image. A certificate states the certification body, the certificate number, the issue and expiry dates and the certified scope.
- 2Check the scope wording against the product you are buying. A certificate can cover a company while excluding a specific product line or manufacturing site.
- 3Verify the certificate number with the issuing body or its accreditation registry. Most bodies publish an online lookup.
- 4For CE, ask which regulation and device class apply, and whether a Notified Body was involved. Self-declared Class I is not the same as Notified-Body-assessed sterile product.
- 5Request a recent batch test report alongside the certificate. Certification proves the system; the batch report proves the shipment.
Export documentation set
- Commercial invoice and packing list
- Batch test report / certificate of analysis
- Declaration of conformity (where CE applies)
- Certificate of origin
- Free sale certificate (destination dependent)
- Sterilisation batch record and ETO residual result (sterile items)
- Master carton label proof and pre-shipment photographs
State the destination country in your RFQ so the correct documentation set is quoted with the order. Request a Quote.
FAQ
Certification questions
Is Dzire Surgical India ISO certified?
The company works to ISO 9001:2015 and ISO 13485:2016 quality management practice, WHO-GMP manufacturing practice, and applies CE requirements to applicable product classes. Watermarked copies of these certificates, plus the IEC export registration, are published on this page for download. Certificate numbers and validity dates are not typed out until the current documents are re-verified; unwatermarked copies are shared directly with buyers during the enquiry process.
What is the difference between ISO 9001 and ISO 13485?
ISO 9001:2015 certifies a general quality management system. ISO 13485:2016 is the medical-device-specific standard and adds requirements for risk management, design controls, sterilisation validation, traceability and post-market surveillance. For medical consumables, ISO 13485 is the relevant certification to verify.
Does CE marking cover every product in the catalogue?
No. CE applicability depends on the classification of the specific device and the applicable European regulation. A single CE statement does not cover an entire catalogue. Ask for the scope statement for the exact SKU you intend to import.
Which documents accompany an export shipment?
Commercial invoice, packing list, batch test report or certificate of analysis, declaration of conformity where CE applies, certificate of origin, and a free sale certificate where the destination market requires one. Sterile products additionally carry sterilisation batch records and ETO residual results.
Need pricing for a certified product line?
Send specification, quantity and destination. Quotations include unit price, MOQ, packing configuration and lead time. Export enquiries receive FOB and CIF options.