Quality system

ISO-aligned work while accreditation is in progress.

The laboratory is implementing the structural, resource, process, and management-system requirements of ISO/IEC 17025. Until an accreditation body issues a scope, results are internally controlled reports — not accredited results.

Status

What “working toward ISO/IEC 17025” means here.

ISO/IEC 17025 is an accreditation of technical competence for a defined scope of tests. It is not a general company certificate. Elevated Laboratories will not describe itself as accredited, ISO certified, or “ISO 17025 compliant” as a substitute for a current scope.

Until accreditation is granted, the laboratory still operates with written methods, instrument logs, reference-standard control, and a chain-of-custody record for every sample. Those controls are the foundation of the accreditation project.

Current public statement: Working toward ISO/IEC 17025 accreditation. Not currently accredited.

Accreditation workstream

  • Quality manual and document control
  • Personnel training and competency records
  • Equipment qualification and calibration schedule
  • Method validation / verification files
  • Internal audit and nonconforming-work procedure
  • Uncertainty and traceability where the method requires it
  • Impartiality and confidentiality statements

This list will be updated as each element is closed. Edit the quality page copy when a milestone changes.

Sterile procedures

How the laboratory controls contamination.

Sterile procedure on this site means the laboratory’s own handling controls. It does not mean every client sample is sterile. Sterility or bioburden conclusions appear only when those tests are ordered and reported.

Receipt and chain of custody

Packages are opened in a designated receipt area. Container integrity, label match, and temperature condition are recorded. The received date shown in the member portal is the laboratory receipt date, not the carrier delivery scan.

Aseptic handling for microbiology

Endotoxin and microbial work is segregated from routine chemistry weigh-out. Operators use gloves, designated consumables, and a cleaned work surface. Sample aliquots for LAL and plate counts are taken before chemistry dilution whenever mass allows.

Chemistry contamination control

UHPLC work uses dedicated glassware or single-use vials, filtered solvents, and blank injections in the sequence. Carryover checks are included when a high-level sample precedes a trace-level request.

Environmental controls

The microbiology bench is cleaned on a defined schedule. Growth-media lots are checked. Out-of-limit environmental observations are documented and can delay a microbial report.

Personnel practice

Staff follow written gowning and hygiene rules for microbial and endotoxin benches. Jewelry, food, and non-laboratory containers stay out of controlled work areas.

What we will not claim

We will not mark a COA “sterile” based on visual inspection, client statement, or endotoxin alone. Endotoxin, TAMC/TYMC, and sterility answer different questions and are reported separately.

Confidentiality

Client identities, formulations, and unpublished results are treated as confidential. Public verification is used only when a certificate is marked released in the content file.

When accreditation is granted

The homepage badge, this page, and the COA footer will be updated in js/content.js and the quality copy. Accredited methods will be listed against the official scope. Methods outside scope will remain clearly identified.