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Regulatory References
Calvin Yang edited this page Jun 1, 2026
·
1 revision
Full standards index organized by industry.
| Standard | Relevance |
|---|---|
| AIAG MSA 4th Ed. (2010) | Primary methodology — Average & Range method, K-constants, acceptance thresholds |
| VIM — JCGM 200:2012 | Definitions of measurement uncertainty, trueness, precision, bias |
| ISO/IEC 17025:2017 | Uncertainty budget, accreditation, traceability for calibration labs |
| ILAC P14 | CMC line; U_reference <= 25% of tolerance rule |
| JCGM 100:2008 (GUM) | Type A/B uncertainty, combined u_c, expanded U |
| Standard | Relevance |
|---|---|
| 21 CFR Part 820.72 | US regulatory requirement for gage control and MSA records (FDA QSR) |
| ISO 13485:2016 | International medical device QMS; requires MSA |
| ISO 14971:2019 | Risk management; connects measurement system failure to patient risk |
| Standard | Relevance |
|---|---|
| IATF 16949:2016 | Mandates GR&R studies; annual re-study requirements |
| AIAG APQP 3rd Ed. | GR&R required in Control Plan MSA section |
| AIAG PPAP 4th Ed. | Level 3 requires full GR&R raw data + summary |
| VDA Volume 5 | ndc >= 8 for SPC-critical parameters; Q_MS ratio |
| Standard | Relevance |
|---|---|
| AS9100D | <=10% GRR for flight-critical dimensions |
| NADCAP AC7130 | Accreditation criteria for MSA in special processes |
| SAE ARP9013 | Acceptance sampling and measurement requirements |
| Standard | Relevance |
|---|---|
| CLIA 42 CFR Part 493 | TEa for regulated analytes; US lab regulatory framework |
| ISO 15189:2022 | International lab accreditation; precision and bias required |
| CLSI EP05-A3 | Within-run, between-run, between-day precision protocol |
| CLSI EP15-A3 | Abbreviated user verification protocol |
| CLSI EP09 | Method comparison and bias estimation |
| Standard | Relevance |
|---|---|
| ISO 50001:2018 | M&V requirements; measurement uncertainty limits |
| IEC 61869 | Accuracy class for current and voltage transformers |
| ASME PTC 19.1 | Uncertainty methodology for power plant performance testing |
| OIML R 46 | Accuracy classes 0.1 through 2.0 for revenue meters |
| IPMVP | M&V protocol; Option D is the GRR-equivalent for energy metering |
| Standard | Relevance |
|---|---|
| MIL-STD-45662A | DoD baseline for M&TE control |
| MIL-HDBK-1828 | DoD MSA; Method 3 for reliability-based calibration intervals |
| ANSI/NCSL Z540.3 | TUR >= 4:1; guard banding when TUR < 4:1 |
| MIL-DTL-28778 | Calibration requirements for mil-spec torque tools |
| ASME B89.4.10348 | CMM volumetric performance verification |
| Resource | Description |
|---|---|
| NIST Handbook 44 | Specifications for weighing and measuring devices in US commerce |
| NIST SP 1297 | Guidelines for expressing uncertainty of NIST measurement results |
| BIPM | Maintains SI and coordinates international traceability |
| JCTLM | Reference methods and materials for clinical labs |
In build_pdf_report() in grr_tool.py:
# Medical device (default)
"Regulatory basis: 21 CFR Part 820.72 (FDA QSR)."
# Automotive
"Regulatory basis: IATF 16949:2016 / AIAG PPAP 4th Ed. / VDA Volume 5."
# Aerospace
"Regulatory basis: AS9100D / NADCAP AC7130 / SAE ARP9013."
# Clinical laboratory
"Regulatory basis: CLIA 42 CFR Part 493 / ISO 15189:2022 / CLSI EP05-A3."
# Defense
"Regulatory basis: ANSI/NCSL Z540.3 / MIL-STD-45662A."See Customizing the Tool for full details.