Quality / ISO / Accreditation
Quality systems, documentation, internal audits, accreditation preparation and support, corrective actions, and applicable ISO requirements.
A quality system only works if it holds up under an audit and reflects how the operation actually runs. AsteRisk helps specialty gas companies build, document, and maintain quality systems — and prepare for accreditation and internal or external review.
Standards we support
Mock Audit & Gap Assessment
An objective, third-party review of your compliance systems to identify gaps, reduce regulatory risk, and support continuous improvement — before a real audit does it for you.
This gives your leadership a snapshot of compliance in critical areas, so you can:
- Quickly determine compliance gaps against government regulations and enforcement discretion, industry consensus standards (CGA, ISBT, and others), and your own written procedures
- Objectively assess opportunities for ongoing compliance improvement
- Develop an action plan with priority items front-loaded
Scope can include
FDA Medical Gas Regulations
21 CFR 211 & 213 (Medical CGMP), 21 CFR 230 (Safety Reporting), 21 CFR 201, 205 & 207 (Registration, Listing, Labeling & Distribution).
FDA Food Gas Regulations
21 CFR 117 — Registration, CGMP, Allergen Awareness, HARPC, Supplier Qualification, and Distribution Controls.
ISBT Standards
Carbon Dioxide and Nitrogen production and testing.
FDA Device Regulations
21 CFR 820, plus Quality System Management for clinical blood gases, lung diffusion mixtures, and similar products.
Gas Chromatography
Method review and analytical practice as part of your quality system.
Data Integrity
Review of recordkeeping and data practices against expected standards.
The scope of your assessment depends on your facility's needs — and where documented training fits your scope, we may be able to conduct it during the same visit.
What you'll receive
- A written report and key-element scorecard
- A documented FDA Annual Records Review for your files
- A draft action plan listing key compliance gaps and opportunities
- A training record for any CGMP or other training provided
- A CGMP certificate, if desired
Timeline
Most food and medical gas facility assessments take one day onsite plus a half day offsite. Assessments that also include an FDA Device or Gas Chromatography/Data Integrity review typically add one additional onsite day. You'll receive the draft report and accompanying records within one week of the onsite assessment.
Have a specific quality or accreditation question?
Tell us what you're working on and we'll point you to the right person or resource.
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