Length: 2 Days

ISO 9001 / AS9100 – Quality Management Systems Fundamentals Training by Tonex

Machine Learning for Pharmaceutical Manufacturing and Quality Control Training

Master the essentials of modern Quality Management Systems and translate standards into results-driven practice for regulated and high-reliability industries. Participants learn how ISO 9001 and AS9100 requirements shape policy, process, and culture to deliver consistent quality and measurable customer satisfaction. The course bridges strategy with daily operations, showing how risk-based thinking, process controls, and corrective actions prevent defects and waste. Impact on cybersecurity is highlighted through secure documentation control, change management rigor, and supplier oversight for digital artifacts. You will connect QMS disciplines to protecting data integrity, audit trails, and configuration baselines, strengthening organizational resilience against cyber-enabled quality failures.

Learning Objectives

  • Explain ISO 9001 and AS9100 principles and clause structures
  • Apply process-based thinking to map, measure, and improve workflows
  • Use risk-based approaches to prioritize controls and mitigation actions
  • Build effective document control, records retention, and change control
  • Plan and execute internal audits and management reviews for outcomes
  • Integrate QMS with cybersecurity by safeguarding data, traceability, and configuration integrity

Audience

  • Quality Managers and Engineers
  • Operations and Manufacturing Leaders
  • Program and Project Managers
  • Process Owners and Business Analysts
  • Compliance and Regulatory Specialists
  • Cybersecurity Professionals

Course Modules

Module 1 — QMS Foundations

  • Quality principles and terminology
  • Process approach and interactions
  • PDCA and continual improvement
  • Risk-based thinking essentials
  • Leadership, policy, objectives
  • Organizational context and needs

Module 2 — ISO 9001 Structure

  • Clause-by-clause overview
  • Planning and operational control
  • Support, competence, awareness
  • Documented information control
  • Supplier and procurement controls
  • Performance evaluation metrics

Module 3 — AS9100 Aerospace Focus

  • Product safety and reliability
  • Counterfeit part prevention
  • Configuration management rigor
  • Special processes and approvals
  • FOD and risk mitigation
  • Traceability and serialization

Module 4 — Process & Risk Management

  • Process mapping and SIPOC
  • KPI selection and alignment
  • FMEA and control planning
  • Root cause and CAPA discipline
  • Statistical thinking basics
  • Operational risk dashboards

Module 5 — Documentation & Audits

  • Document hierarchy and flow
  • Change control and records
  • Internal audit lifecycle
  • Objective evidence gathering
  • Findings, grading, follow-up
  • Management review effectiveness

Module 6 — Implementation & Improvement

  • Readiness and gap assessment
  • Roadmaps and governance
  • Supplier quality integration
  • Digital QMS and automation
  • Culture, skills, change enablement
  • Sustaining outcomes and maturity

Elevate quality performance and certification readiness with Tonex. Enroll now to align ISO 9001 and AS9100 requirements with practical controls, stronger cybersecurity assurance, and repeatable operational excellence.

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