QUALITY

QUALITY = QUALITY_STANDARD × CANONIC = Structure(quality) × (C1, C2, Temporal, Relational, C5) = owned quality vertical

QUALITY = C1 ∩ C2 ∩ Temporal ∩ Relational ∩ C5 ∩ C6 = ENTERPRISE (#63)

Quality requires full Enterprise because:

• C1: Quality policy and objectives must be stated
• C2: Conformance must be demonstrated
• Temporal: Audit cycles, corrective action timelines
• Relational: Process boundaries, scope definition
• C5: Management review, auditors enforce
• C6: ISO/industry QMS standards

1. Customer Focus

Quality systems MUST be oriented toward meeting customer requirements and enhancing satisfaction.

Example: A software product team collects customer feedback through support tickets, surveys, and usage analytics. Product requirements trace to customer needs. Release decisions consider customer impact.

2. Process Approach

Work MUST be managed as processes with defined inputs, activities, outputs, and controls.

Example: A manufacturing process defines: raw material specifications (input), machining steps (activities), finished part specifications (output), and inspection checkpoints (controls). Each element is documented and measured.

3. Continual Improvement

The organization MUST continually improve the effectiveness of the quality management system.

Example: Monthly quality metrics show defect rate trending upward. Root cause analysis identifies training gap. Corrective action: update training program. Verification: defect rate returns to baseline within two months.

4. Evidence-Based Decision Making

Decisions MUST be based on analysis of data and information.

Example: A decision to change suppliers requires: current supplier performance data, alternative supplier evaluation, cost-benefit analysis, risk assessment, and approval documentation. Opinion alone is insufficient.

5. Nonconformance Control

Nonconforming products or services MUST be identified, controlled, and prevented from unintended use.

Example: An inspection finds a batch of components out of specification. The batch is: physically segregated, labeled as nonconforming, evaluated for disposition (rework, scrap, use-as-is), and documented. Release requires authorized approval.

Pattern: All quality standards = ENTERPRISE (#63)

`` DECLARE(ISO9001) = ISO_9001 × CANONIC

Where: ISO 9001 provides Structure: - Context of organization (Clause 4) - Leadership (Clause 5) - Planning (Clause 6) - Support (Clause 7) - Operation (Clause 8) - Performance evaluation (Clause 9) - Improvement (Clause 10)

CANONIC provides Governance: - C1: Quality policy as CANON - C2: Records in COVERAGE - Temporal: Audit schedules, review cycles - Relational: Scope boundaries, process interactions - C5: Management review, certification body

Result: ISO9001 = ENTERPRISE (#63)

Certification Lifecycle: Gap Assessment = COMMUNITY - Current state vs. standard Documentation — QMS documented Implementation — Processes operating Internal Audit = BUSINESS - Self-assessment Stage 1 Audit = BUSINESS - Documentation review Stage 2 Audit = ENTERPRISE- Implementation audit Certified — Certificate issued Surveillance — Annual audits ``

`` DECLARE(CAPA) = FDA_CAPA × CANONIC

Where: CAPA Framework: - Identification of nonconformance - Root cause analysis - Corrective action - Preventive action - Verification of effectiveness

CANONIC provides Governance: - C1: Problem statement, root cause - C2: Investigation records, test results - Temporal: Due dates, verification timeline - C5: Approval, closure

Result: CAPA = REGULATION (#27)

CAPA Lifecycle: Identify — Nonconformance reported Contain — Immediate action Analyze — Root cause determined Correct — Action implemented Verify — Effectiveness confirmed Close — CAPA completed ``

To create a CANONIC quality vertical:

Select quality standard (ISO 9001, 13485, etc.) Create scope with CANON.md inheriting /QUALITY/ Define quality policy and objectives Document processes (procedures, work instructions) Establish records (inspection, audit, review) Define process boundaries (scope, interactions) Implement management system (audits, reviews) Achieve certification (registrar audit)

Result: Owned quality vertical with certified QMS.

QUALITY × MEDICINE = Clinical quality, ISO 13485 (NCQA + ISO 9001) QUALITY × AEROSPACE = Aviation quality, AS9100 (IAQG + ISO 9001) QUALITY × AUTOMOTIVE = Automotive quality, IATF 16949 (IATF + ISO 9001) QUALITY × MANUFACTURING = Manufacturing quality, GMP (ISA-95 + ISO 9001) QUALITY × DEFENSE = Defense quality, MIL-Q-9858 (DoD + ISO 9001) QUALITY × GENOMICS = Lab accreditation, CAP proficiency (CAP + ISO 15189) QUALITY × ENERGY = Nuclear quality, NQA-1 (NRC + ISO 9001) QUALITY × LOGISTICS = Supply chain quality, ISO 28000 (GS1 + ISO 9001) QUALITY × FINANCE = Internal controls, SOC reporting (COSO + ISO 9001) QUALITY × EDUCATION = Academic quality, accreditation (SACSCOC + ISO 21001)

10 cross-domain compositions. Each strengthens PROV-001 and PROV-004 patent claims.

Gap: No existing system provides governance-gated quality management with O(1) bitwise checking across ISO 9001, 13485, AS9100, and cross-domain composition.