Nine regulatory standards. One place to read against them.
Each standard is implemented from its source text, with the same clause numbering you'd see on an audit report. 2,157 clauses indexed in total. Click a standard to drill in.
ISO 13485
Medical device QMS
280 CLAUSESLIVE
ISO 9001
General QMS
234 CLAUSESLIVE
AS9100D
Aerospace
283 CLAUSESLIVE
FDA QMSR
US medical device · 21 CFR 820
290 CLAUSESLIVE
EU MDR
EU medical device · 2017/745
431 CLAUSESBETA
MDSAP
Multi-country medical-device audit
90 TASKSBETA
ISO 14971
Risk management for medical devices
141 CLAUSESBETA
ICH Q10
Pharma QMS
58 CLAUSESBETA
ICH Q7
Pharma · APIs / GMP
350 CLAUSESBETA
SELECTED STANDARD
ISO 13485:2016 — Medical devices — Quality management systems
Read byMedical device manufacturers, contract manufacturers, suppliers in the device value chain
SECTIONS
§4Quality management system
§5Management responsibility
§6Resource management
§7Product realization
§8Measurement, analysis, improvement
TOTAL280 CLAUSES INDEXED
SAMPLE FINDING — what Aligntra returns
ISO 13485 · 7.5.6
PARTIAL
Validation of processes for production and service provision
Source clause
"The organization shall validate any processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement…"
Aligntra finding
Validation protocol present in QM-VAL-002.pdf p.7 §2; revalidation cadence not specified.
ISO 9001:2015 — Quality management systems — Requirements
Type and extent of control of externally provided processes
Source clause
"The organization shall determine the controls to be applied to externally provided processes, products and services."
Aligntra finding
Supplier controls procedure SUP-CTL-009.pdf p.3 §2.1, last revised 2025-11-04.
AS9100D — Quality management systems for aerospace, space and defense
Read byAerospace primes, suppliers, MROs — anyone in the AS supply chain
SECTIONS
§4Context of the organization
§5Leadership
§6Planning + risk + product safety
§7Support
§8Operation incl. counterfeit-parts prevention
§9Performance evaluation
§10Improvement
TOTAL283 CLAUSES INDEXED
SAMPLE FINDING — what Aligntra returns
AS9100D · 8.1.4
GAP
Counterfeit parts prevention
Source clause
"The organization shall plan, implement and control processes for the prevention of counterfeit or suspect-counterfeit-part use."
Aligntra finding
No procedure found referencing counterfeit-part prevention. Searched 22 documents.
FDA QMSR · 21 CFR Part 820 — Quality Management System Regulation
Read byUS medical device manufacturers (effective Feb 2026, replacing 21 CFR 820)
SECTIONS
AGeneral provisions
BQuality management system requirements
CRecords
DDefinitions
TOTAL290 CLAUSES INDEXED
SAMPLE FINDING — what Aligntra returns
FDA QMSR · §820.30(i)
GAP
Design changes — post-market evaluation
Source clause
"Each manufacturer shall establish and maintain procedures for the identification, documentation, validation, review and approval of design changes before their implementation."
Aligntra finding
SOP-DC-007 Rev 03 documents change control but no post-market evaluation step for devices already in field.
EU MDR 2017/745 — Medical Device Regulation
Read byMedical device manufacturers placing devices on the EU market
"The manufacturer shall maintain procedures for reporting adverse events to each regulatory authority in accordance with country-specific timeframes."
Aligntra finding
AE reporting procedure references US/EU only. AU TGA, JP PMDA, BR ANVISA, CA HC missing.
ISO 14971:2019 — Application of risk management to medical devices
Read byMedical device manufacturers; integrates with ISO 13485 §7.1
SECTIONS
§4General requirements
§5Risk analysis
§6Risk evaluation
§7Risk control
§8Evaluation of overall residual risk
§9Risk management review
§10Production and post-production activities
TOTAL141 CLAUSES INDEXED
SAMPLE FINDING — what Aligntra returns
ISO 14971 · §7.4
CONFIRMED
Benefit-risk analysis when residual risk is not acceptable
Source clause
"If the residual risk is not acceptable using the criteria, the manufacturer shall analyze whether the medical benefits of the intended use outweigh the residual risk."
Aligntra finding
Benefit-risk methodology in RM-PLAN-001.pdf p.11 §4.3, applied per-hazard in RM-FILE-001.pdf.
ICH Q10 — Pharmaceutical Quality System (PQS)
Read byPharma manufacturers establishing/maintaining a PQS across the product lifecycle
SECTIONS
§1-2Scope + management responsibility
§3Continual improvement of process performance and product quality
§4Continual improvement of the PQS
§5Knowledge management + quality risk management
TOTAL58 CLAUSES INDEXED
SAMPLE FINDING — what Aligntra returns
ICH Q10 · §3.2.4
PARTIAL
Continued process verification (CPV) trending
Source clause
"Process performance and product quality monitoring system… should provide assurance of continued capability of processes and controls to produce a product of desired quality."
Aligntra finding
CPV plan present; trending cadence stated quarterly but logs show last review 7 months ago.
ICH Q7 — Good Manufacturing Practice for Active Pharmaceutical Ingredients
§13-19Change control + complaints + APIs by special routes
TOTAL350 CLAUSES INDEXED
SAMPLE FINDING — what Aligntra returns
ICH Q7 · §12.4
CONFIRMED
Computer system validation — CSV master plan
Source clause
"Computerized systems should be validated according to a written protocol that defines the scope and objectives of the validation."
Aligntra finding
CSV master plan CSV-MP-002.pdf p.6 §3, scope covers MES + LIMS + ERP-quality module.
CLAUSE COUNTS
Authoritative count per standard.
Counts pulled from each standard's source text — auditable IDs only. No fabricated numbers.
Standard
Title
Clauses
Industry
ISO 13485:2016
Medical devices — Quality management systems
280
MEDDEV
ISO 9001:2015
Quality management systems — Requirements
234
ALL
AS9100D
QMS — Aviation, Space, and Defense Organizations
283
AERO
FDA QMSR · 21 CFR 820
FDA Quality Management System Regulation (effective Feb 2026)
290
MEDDEV
EU MDR 2017/745
Medical Device Regulation — making available, GSPRs, post-market
431
MEDDEV
MDSAP
Medical Device Single Audit Program (AU, BR, CA, JP, US)
90
MEDDEV
ISO 14971:2019
Application of risk management to medical devices
141
MEDDEV
ICH Q10
Pharmaceutical Quality System
58
PHARMA
ICH Q7
Good Manufacturing Practice for Active Pharmaceutical Ingredients
350
PHARMA
2,157 clauses indexed across 9 standards (4 live · 5 beta) · sourced from each standard's published text
METHODOLOGY
How we index a standard.
Each standard goes through the same three-step indexing process before it goes live. Custom standards (Enterprise) follow the same workflow.
1 — Parse from source text
We work from the published standard. Clauses are extracted with the same numbering structure (e.g. ISO 13485 §7.3.7) so audit reports match exactly what your registrar uses.
2 — Structure the hierarchy
Parent clauses, lettered sub-requirements, and the testable assertions inside each clause are registered individually — so a finding lands on §7.3.7, not somewhere in "section 7."
3 — Verify with real auditors
Before a standard goes live, we run dozens of test audits against published example QMS documents and have a senior QA reviewer validate the verdicts. No standard ships at the "we think this is right" stage.
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