✉ quotes@premierlabglass.com | Mon–Fri 8a–5p ET

Quality Assurance

How we run the quality system, what documentation ships with the order, and how customer audits work.

Quality Management System

Our quality management system is ISO 9001:2015 registered, scoped to cover the design, fabrication, inspection, and shipment of laboratory glassware. The active certificate and the most recent surveillance-audit summary are available under NDA on request.

Process Controls

The QMS spans every step that touches the piece: drawing-review checklist, raw-material lot trace, fabricator sign-off at each station, anneal-cycle log with controlled cool-down, post-anneal polariscope inspection, dimensional verification, volumetric calibration where applicable, and final shipment-readiness sign-off. Records are keyed to the customer order number and are retained for at least seven years.

Calibration & Traceability

Volumetric apparatus calibration is performed against references traceable to NIST through the supplier chain documented in the calibration certificate. Class A volumetric flasks, pipettes, and burettes ship with a NIST-traceable calibration certificate at no additional charge.

Documentation Shipped With the Order

The following documents are included by default or on request:

  • Certificate of Inspection (default — every shipment).
  • NIST-traceable Calibration Certificate (default — every Class A volumetric piece).
  • Material Test Report (on request — names the glass-supplier lot ID and composition).
  • Certificate of Origin (on request — for Buy American Act, federal contract, or international shipping).
  • DSCSA Pedigree (default — pharmaceutical orders).
  • USP <660> / <1660> / <87> / <88> Compliance Letter (on request).
  • Pressure or Vacuum Test Record (default — pilot reactors).
  • EAR / ITAR Classification Letter (on request — international and controlled orders).

Customer Audits

We welcome customer-led supplier audits. Coordinate scheduling, scope, and confidentiality terms with quality@premierlabglass.com. We typically can host an on-floor audit within four to six weeks of request. We have hosted audits from FDA-aligned client QA teams, university EH&S programs, federal supply officers, and ISO surveillance auditors.

Corrective & Preventive Action

Customer non-conformance reports are entered in our CAPA system within one business day, investigated to root cause, and tracked to a documented corrective action. The customer receives a written response, typically within ten business days for routine issues and within twenty-four hours for safety- or recall-class issues.

Contact

QA documentation requests, audit scheduling, supplier-qualification packets, and CAPA correspondence: quality@premierlabglass.com.

Effective2026-04-28
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