RFQ IHS1519384A Questions and Answers.pdf

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Attached to
Amendment 3: Closing Date Extension - Phoenix Area IHS Dental Equipment PM and Repair Services IDIQ contract
Solicitation number
IHS1519384A
Issued by

About this file

This document is a Questions and Answers file for RFQ IHS1519384A, which concerns Phoenix Area IHS Dental Equipment Preventive Maintenance and Repair Services under an Indefinite Delivery Indefinite Quantity (IDIQ) contract. The file addresses a single clarification question regarding ISO 13485:2016 certification requirements. The contracting officer clarifies that active ISO 13485:2016 Certification meeting all requirements of the Medical Device Quality Management System standard is mandatory for the prime contractor, not acceptable for a subcontractor alone. This Q&A document does not specify detailed service requirements, pricing terms, response dates, or other solicitation particulars beyond this certification requirement clarification.

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RFQ IHS1519384A - Phoenix Area IHS Dental Equipment PM and Repair Services IDIQ contract: Questions and Answers

1. Could you please confirm whether this certification is required for the prime contractor, or if it would be acceptable for a subcontractor to hold the ISO 13485:2016 certification?

It is required that the prime contractor holds active ISO 13485:2016 Certification that meets all requirements of the Medical Device Quality Management System standard.

File details come from the government source that posted it. Updated .