Panel for ISO 13485:2016 Certification Services.
Ruth Springbok
In plain English
The National Health Laboratory Service is seeking service providers for ISO 13485:2016 certification services for a period of five years. Bidders must be registered on the Central Supplier Database and comply with tax obligations.
Always check the official documentDescription
The National Health Laboratory Service (NHLS) invites bids for the appointment of a panel of service providers to perform ISO 13485:2016 certification services. The work involves auditing Quality Management Systems at four Diagnostic Media Products (DMP) facilities located in Green Point, Port Elizabeth, Sandringham, and KwaZulu-Natal. The contract will span a period of five years. Key deliverables include conducting gap assessments, stage 1 and 2 certification audits, and ongoing surveillance audits. Service providers must manage non-conformities, provide formal audit reporting, and ensure independent certification decision-making. Bidders must demonstrate at least five years of experience in the medical device sector and provide auditors with recognized lead auditor qualifications. The tender reference is RFQ1940102 – 26/27, and the closing date for submissions is 20 October 2026 at 12:00 pm.
What you need to qualify
- CSD registration — Registration on the Central Supplier Database — required to do business with government.
- Tax clearance — A valid SARS tax compliance status (PIN) showing your tax affairs are in order.
- B-BBEE certificate — A B-BBEE certificate or sworn affidavit confirming your contribution level.
Full requirements
- ISO 13485:2016 accreditation from SANAS or IAF MLA signatory
- Registered on National Treasury Central Supplier Database (CSD)
- Valid Tax Compliance Status (TCS) PIN or certificate
- Valid B-BBEE certificate or sworn affidavit
- Auditor or Lead Auditor certification (IRCA or equivalent)
Contact & how to apply
Name: Ruth Springbok
Email: ruth.springbok@nhls.ac.za
Phone: 011-386-6000
How to apply: Bids must be submitted via email to Ruth.Springbok@nhls.ac.za by 12:00 pm on 20 October 2026. Late submissions will not be accepted.
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