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

> This tender closed on 2026-10-20.

- **Reference:** RFQ1940102
- **Issuer:** [National Health Laboratory Service](https://za.bidwunder.com/tenders/issuer/national-health-laboratory-service.md)
- **Region:** Gauteng
- **Type:** Request for quotation
- **Published:** 2026-09-28
- **Closing date:** 2026-10-20 14:00 SAST

## Summary

#### 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.

## Description

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

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

Conditions: N/A

## Documents

- ANNEXURE B\_ISO 13485\_Pricing Schedule.pdf..pdf
- Annexure A\_ ISO 13485 Audit specifications and Funcionalities.pdf..pdf
- Request for Quotation (RFQ)\_ISO 13485 \_Rev01\_280926.pdf..pdf

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## Published on

- [eTenders.gov.za](https://www.etenders.gov.za)

More open tenders: https://za.bidwunder.com/tenders.md

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> Source: https://za.bidwunder.com/tenders/for-the-appointment-of-a-panel-of-service-providers-for-iso-13485-2016-for-a-per-e5d8df6d