Standards & compliance

Codes, standards and regulations we engineer to.

Every OneFit Projects deliverable references the governing framework it was produced under. This page lists the principal standards our teams design, validate, inspect and document against across our industries. Sector-specific lists appear on each industry page.

ISO 9001
Quality management systems
ISO 13485
Medical device quality management
ISO 14971
Medical device risk management
IEC 60601
Medical electrical equipment safety
21 CFR 820 / QMSR
US FDA quality system regulation
GAMP 5
Computerised system validation
21 CFR Part 11
Electronic records & signatures
ASME BPVC VIII
Pressure vessel design
ASME B31.3
Process piping
PED 2014/68/EU
European pressure equipment
API 650 / 620
Storage tank design
AWS D1.1
Structural welding
ISO 12100
Machinery safety & risk assessment
IEC 62061 / ISO 13849
Functional safety of machinery
IEC 61508 / 61511
Functional safety, process industry
ISO 10218
Industrial robot safety
AS9100
Aerospace quality management
IATF 16949
Automotive quality management
ISO 26262
Automotive functional safety
ISO 55000
Asset management
ISO 50001
Energy management
ISO 9712 / ASNT SNT-TC-1A
NDT personnel qualification
IEC 62443
Industrial cybersecurity
ISO/IEC 42001
AI management systems
ISO 17025
Testing & calibration laboratories
IVS / RICS Red Book
Plant & machinery valuation

Standards listed indicate the frameworks our engineering, validation and inspection work is performed and documented against. Where a project requires certification by a notified body, authorised inspector or accredited laboratory, we prepare the technical evidence and coordinate the certification process on our client's behalf.

Quality system

How we assure our own work

Controlled documents

Every calculation, drawing, protocol and report is version-controlled, reviewed and approved before release.

Independent review

Design, analysis and validation work is checked by an engineer who did not produce it, with documented review records.

Traceability

Requirements trace to design, design to verification, and verification to evidence, in a matrix the auditor can follow.

Qualified people

NDT personnel, welding inspectors, functional-safety and validation engineers hold the certifications their work requires.

Data security

Client data, drawings and code are handled under NDA with access control, encrypted storage and secure transfer.

Continuous improvement

Lessons learned, non-conformances and client feedback feed a CAPA process that improves our methods.

Need a compliance partner for your next project?

Share the scope, constraints and timeline. A senior engineer will respond with a practical path forward, whichever discipline it touches.

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