For the appointment of a panel of service providers for ISO 13485: 2016 for a period of five (5)Closed

Overview

The NHLS seeks to appoint a panel of ISO 13485:2016 certification service providers for NHLS Diagnostic Media Products (DMP) facilities for a five-year term. Bidders should be accredited certification bodies (SANAS or other MLA-signatory) with demonstrable ISO 13485 auditing/certification experience, including IVD/medical device clients, and the ability to perform gap assessments, staged audits, and provide per-facility pricing.

Requirements

• Accredited certification body with a valid scope covering ISO 13485:2016 (SANAS or MLA signatory).
• Demonstrated ISO 13485 certification experience (preferably 5+ years; per references and client contracts).
• Demonstrated IVD/medical device manufacturer certification experience of comparable size/regulatory environment.
• Auditors proposed must hold recognised medical device QMS qualifications (e.g., IRCA) with relevant audit experience.
• Ability to provide a clear certification methodology, capacity to service all NHLS DMP facilities, and references for comparable contracts.
• Compliance with tax, CSD, and BBEE requirements; potential security clearance; and alignment with NHLS legal/contractual terms.
• Mandatory returnable documents (e.g., SBD1, RFQ Certificate, Specific Goals Form, BBBEE documentation, CSD registration, Tax Compliance Certificate).

How to Apply

• Deadline: closing 20 October 2026 at 12:00 (queries due 14 Oct 2026, 16:00).
• Submission: via NHLS bid box at the stated address and/or email Ruth.Springbok@nhls.ac.za.
• Documents to submit (from attached package): official bid response forms and returnable documents, Annexure A (ISO 13485 Audit Specifications) and Annexure B (Pricing Schedule)—see Annexure A_ISO 13485 Audit specifications and Funcionalities.pdf and ANNEXURE B_ISO 13485_Pricing Schedule.pdf.
• Registrations/pre-qualifications: SARS Tax Compliance (PIN) or TCS; Central Supplier Database (CSD) registration; BBBEE documentation or sworn affidavit for specific goals; DPIP/FPPO disclosures if applicable.
• Briefing: Formal briefing is not held; submit queries by email as outlined in the RFQ (responses posted to all bidders).
• Where to obtain: the RFQ package and annexures are in the NHLS RFQ (RFQ1940102–26/27); pricing and technical specs in Annexure B and Annexure A.