ISO 13485:2016 Certified
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QUALITY-FOCUSED SURGICAL INSTRUMENT MANUFACTURING | MUMBAI, INDIA

Quality & ISO Standards at Bharat Surgical

Bharat Surgical Co. follows a requirement-led quality approach for the surgical instruments it manufactures and supplies. Product identification, dimensions, construction, finish, assembly, movement, fit, function, order accuracy and documentation are reviewed as applicable to the confirmed instrument and purchase requirement.

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Established 1975
Mumbai Manufacturing
ISO 13485:2016 Certified
Requirement-Based
ISO 13485:2016
Quality Management System
Requirement Review
Prior to Order Confirmation
Full Documentation
For Tenders & Procurement
Commitment

Our Quality Commitment

Quality begins with correctly identifying what the buyer needs. Instruments with similar names may differ in diameter, length, jaw or tip pattern, handle, connection, assembly and intended compatibility.

Bharat Surgical therefore encourages buyers to define the required configuration and acceptance criteria before the order is confirmed.

The applicable review depends on the instrument and agreed supply scope. A reusable hand instrument, trocar assembly, needle holder, grasper, sheath or powered-equipment accessory does not require the same checks. Product-specific specifications, inspection records, certificates, marking, packing and any special acceptance requirement should be agreed in the quotation or order confirmation.

Quality inspection of surgical instruments
Certification

ISO-Certified Quality Management System

Bharat Surgical's quality-management system is certified to ISO 13485:2016 for medical devices.

Verified Certificate Information

  • Certified Standard: ISO 13485:2016
  • Certificate Number: RQMD91/11579
  • Certified Organization: BHARAT SURGICAL CO.
  • Certification Body: INTERNATIONAL CERTIFICATION SERVICES PVT. LTD. (ICS)
  • Issue Date: 21st September, 2024
  • Valid Until: 11th September, 2027
  • Certified Scope: Manufacturing, Sale, Servicing of Laparoscopy, Urology, Gynecology, Micro and General Surgery Instruments.
Download Current Certificate PDF

Important Distinction

ISO 13485 certification concerns the organization's quality-management system within the stated certified scope. It does not by itself mean that every instrument is CE marked, US FDA cleared or registered, BIS certified, sterile, or approved for every market.

Product-specific claims must be supported by separate current evidence. Please request product-specific regulatory documentation during your enquiry.

Controls

Quality Controls Applied to the Confirmed Requirement

The following areas may be checked depending on the product, specification and order. The final inspection scope for a particular purchase is the scope stated in the approved quotation, drawing, specification or order confirmation.

Requirement and Configuration Review

The product name, pattern, size, working length, tip or jaw, handle, connection, accessories, compatibility details and quantity supplied by the buyer are reviewed to identify the intended configuration.

Material and Construction Confirmation

Material grade, component construction and any controlled material evidence should be stated when they are essential to the order. Buyers requiring a material certificate must request it before quotation.

Dimensional and Visual Inspection

As applicable, inspection may cover important dimensions, overall construction, alignment, surface condition, visible workmanship, edges, joints and the agreed pattern.

Assembly, Movement and Functional Review

For assembled or moving instruments, review may include opening and closing action, engagement, release, alignment, locking, fit between supplied components and other product-appropriate functional observations.

Documentation

Quality Documents Buyers Can Request

Ensure you request the exact documents required for your procurement process.

Document or Evidence How it should be handled
Current ISO certificate Provide the readable current certificate showing the legal name, standard, scope, certificate number, certification body and validity.
Product specification Confirm the offered size, pattern, material or finish, connection, included components and other controlled details.
Approved drawing or sample Use for custom or non-standard items when dimensions, tolerances or interfaces must be accepted before production.
Inspection or QC record Request before order; confirm whether an item-wise, batch-wise or standard internal record is available for the offered product.
Material evidence Request before quotation; confirm whether a material certificate or traceability record applies and can be supplied.
Regulatory document Confirm applicability to the exact product and destination. Do not rely on a general company document.
Commercial/export documents State the required invoice, packing list, country-of-origin or other shipment documents during enquiry.
Sterility or processing status Confirm from the product label, quotation and supplied instructions whether the item is sterile or non-sterile.
Preparation

Information to Share Before Ordering

Providing complete details helps ensure the right product and quality documentation are supplied.

Product Identity

Instrument name, catalogue reference if available, speciality and intended requirement.

Technical Details

Size, diameter, length, pattern, tip or jaw, handle, connection, material, finish and equipment interface where relevant.

Acceptance Requirements

Critical dimensions, tolerances, drawing, sample reference, inspection level and approval method for custom or controlled items.

Documentation & Commercial

Required certificate, inspection record, material evidence, regulatory document, quantity, delivery location, and expected schedule.

Quality FAQs

Frequently Asked Questions

Common questions regarding our quality standards, ISO certification and inspection process.

Yes. Bharat Surgical Co. is certified to ISO 13485:2016, Certificate No. RQMD91/11579, Scope: Manufacturing, Sale, Servicing of Laparoscopy, Urology, Gynecology, Micro and General Surgery Instruments, Valid Until: 11th September, 2027.

A readable copy is linked in the certification section of this page, showing the certified legal name, standard, scope, certificate number, certification body, issue date and validity.

No. ISO 13485 and CE marking are different. CE status must be verified for the exact product through current product-specific regulatory documentation.

Sterile status must be confirmed for the exact item from its quotation, label and supplied documentation. Reusable instruments supplied non-sterile must pass through the buyer's validated cleaning and sterilization process.

Keep the packing and product identification, do not place the disputed item into use, and send Bharat Surgical the order or invoice reference, item details, photographs or video and a clear description for review.

Need Quality Documents for a Surgical Instrument Enquiry?

Send the product name, specification, quantity, delivery destination and the exact certificates or inspection documents required. Bharat Surgical will review the request and confirm which documents and quality checks apply to the offered product.

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