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REQ-ISO-001: Quality Management System

Overview​

Purpose: QMS establishment and documentation
ISO Clause: 4.1 General Requirements
Category: core, qms
Priority: High
Framework: ISO 13485

Description​

Establishes the overall quality management system framework, including quality policy, objectives, and organizational structure for medical device development.

Acceptance Criteria​

Feature: Quality Management System Compliance Validation
  As a compliance auditor
  I want to validate QMS implementation
  So that I can verify ISO 13485 compliance

  Background:
    Given the organization develops medical devices
    And ISO 13485 compliance is required
    And a QMS audit is being conducted

  Scenario: QMS Documentation Audit
    Given a QMS documentation review is conducted
    When the quality manual is examined
    And quality policies are reviewed
    And organizational structure is verified
    Then the QMS framework shall be documented
    And all personnel roles shall be defined
    And quality objectives shall be measurable and documented

  Scenario: QMS Process Effectiveness Audit
    Given QMS processes are operational
    When process implementation is audited
    And training records are reviewed
    And effectiveness monitoring data is examined
    Then processes shall have evidence of operation as documented
    And continuous improvement shall have documented evidence
    And regulatory compliance shall be demonstrable through records

  Scenario: Management Review Audit
    Given management review processes exist
    When management review records are examined
    And performance data analysis is verified
    And improvement actions are tracked
    Then management decisions shall be documented with rationale
    And resource allocation decisions shall be recorded
    And QMS effectiveness evaluation shall be evidenced

Technical Context​

Implementation Requirements​

  • Quality Manual: Comprehensive document describing QMS scope, processes, and procedures
  • Quality Policy: Management's commitment to quality and regulatory compliance
  • Organizational Structure: Clear roles, responsibilities, and authorities
  • Process Documentation: Documented procedures for all QMS processes
  • Training Program: Personnel competence and awareness programs
  • Monitoring System: Performance measurement and improvement processes

System Architecture​

interface QualityManagementSystem {
  qualityManual: QualityManual;
  qualityPolicy: QualityPolicy;
  organizationalStructure: OrganizationalStructure;
  processes: QMSProcess[];
  trainingProgram: TrainingProgram;
  monitoringSystem: MonitoringSystem;
}

interface QualityManual {
  scope: string;
  exclusions: string[];
  processReferences: ProcessReference[];
  documentControl: DocumentControlProcedure;
}

interface QMSProcess {
  id: string;
  name: string;
  purpose: string;
  inputs: ProcessInput[];
  outputs: ProcessOutput[];
  controls: ProcessControl[];
  resources: Resource[];
  monitoring: MonitoringRequirement[];
}

Validation Strategy​

  1. Document Review: Verify QMS documentation completeness and accuracy
  2. Process Audit: Confirm processes operate as documented
  3. Training Verification: Validate personnel competence and awareness
  4. Management Review: Assess management commitment and resource allocation
  5. Continuous Monitoring: Ongoing evaluation of QMS effectiveness

Validation Strategy​

Documentation Validation​

  • Quality manual completeness and accuracy review
  • Process documentation adequacy assessment
  • Training record completeness verification
  • Management review documentation audit

Process Validation​

  • Cross-process interface effectiveness evaluation
  • Document control system audit
  • Training program effectiveness assessment
  • Management review process evaluation

Compliance Validation​

  • End-to-end QMS process audit
  • Regulatory compliance gap analysis
  • Audit readiness assessment
  • Continuous improvement evidence review

Implementation Notes​

Prerequisites​

  • Management commitment and resource allocation
  • Regulatory requirements analysis
  • Organizational structure definition
  • Personnel competence assessment

Dependencies​

  • Document control system (REQ-ISO-004)
  • Management responsibility processes (REQ-ISO-002)
  • Resource management procedures (REQ-ISO-003)

Constraints​

  • Must comply with ISO 13485:2016 requirements
  • Must align with applicable regulatory requirements (FDA, MDR, etc.)
  • Must support medical device lifecycle processes
  • Must enable continuous improvement

Compliance Evidence​

Required Documentation​

  • Quality Manual with QMS scope and processes
  • Quality Policy signed by top management
  • Organizational chart with roles and responsibilities
  • Process documentation and procedures
  • Training records and competence evidence
  • Management review records and decisions

Audit Trail​

  • QMS establishment timeline and milestones
  • Document approval and revision history
  • Training completion records
  • Management review meeting minutes
  • Corrective action records and resolutions
  • REQ-ISO-002: Management Responsibility
  • REQ-ISO-003: Resource Management
  • REQ-ISO-004: Document Control

Note: Individual requirement template files are generated when using sc init --framework=iso13485

Usage Examples​

CLI Commands​

# Generate this requirement
sc req new --template=REQ-ISO-001 --title="Quality Management System"

# Validate implementation
sc req validate REQ-ISO-001 --framework=iso13485

# Generate test cases
sc test generate --requirement=REQ-ISO-001 --type=gherkin

Integration Example​

// QMS implementation validation
const qmsValidator = new ISO13485Validator();
const qmsImplementation = await loadQMSImplementation();

const validationResult = await qmsValidator.validateQMS(qmsImplementation, {
  requirement: 'REQ-ISO-001',
  scope: 'full-qms',
  includeProcesses: true,
  validateTraining: true,
});

if (validationResult.isCompliant) {
  console.log('QMS implementation compliant with REQ-ISO-001');
} else {
  console.log('Gaps found:', validationResult.gaps);
}