Skip to main content
Mastering ISO 14644; The Ultimate Guide to Risk Management and Compliance in Controlled Environments

Mastering ISO 14644; The Ultimate Guide to Risk Management and Compliance in Controlled Environments

$199.00
When you get access:
Course access is prepared after purchase and delivered via email
How you learn:
Self-paced • Lifetime updates
Your guarantee:
30-day money-back guarantee — no questions asked
Who trusts this:
Trusted by professionals in 160+ countries
Toolkit Included:
Includes a practical, ready-to-use toolkit with implementation templates, worksheets, checklists, and decision-support materials so you can apply what you learn immediately - no additional setup required.
Adding to cart… The item has been added

Mastering ISO 14644: The Ultimate Guide to Risk Management and Compliance in Controlled Environments



Course Overview

This comprehensive course is designed to provide participants with a deep understanding of ISO 14644, the international standard for controlled environments. Participants will learn how to manage risk and ensure compliance in a variety of settings, including cleanrooms, laboratories, and manufacturing facilities.



Course Objectives

  • Understand the principles and requirements of ISO 14644
  • Learn how to manage risk and ensure compliance in controlled environments
  • Develop the skills and knowledge needed to implement and maintain an effective risk management system
  • Understand the importance of documentation, record-keeping, and auditing in controlled environments
  • Learn how to identify and mitigate potential risks in controlled environments


Course Outline

Module 1: Introduction to ISO 14644

  • Overview of ISO 14644 and its application
  • History and development of the standard
  • Key principles and requirements of ISO 14644
  • Benefits of implementing ISO 14644

Module 2: Risk Management in Controlled Environments

  • Introduction to risk management in controlled environments
  • Identifying and assessing potential risks
  • Mitigating and controlling risks
  • Monitoring and reviewing risk management systems

Module 3: Compliance in Controlled Environments

  • Understanding compliance requirements in controlled environments
  • Developing and implementing compliance policies and procedures
  • Conducting audits and risk assessments
  • Maintaining records and documentation

Module 4: Cleanroom Design and Construction

  • Principles of cleanroom design and construction
  • Air filtration and circulation systems
  • Surface finishes and materials
  • Lighting and electrical systems

Module 5: Cleanroom Operations and Maintenance

  • Cleanroom operations and procedures
  • Cleaning and disinfection techniques
  • Maintenance and repair of cleanroom systems
  • Training and personnel management

Module 6: Microbiological and Particulate Control

  • Microbiological control in cleanrooms
  • Particulate control in cleanrooms
  • Air sampling and testing methods
  • Surface sampling and testing methods

Module 7: Cleanroom Validation and Verification

  • Cleanroom validation and verification procedures
  • Testing and certification of cleanrooms
  • Ongoing monitoring and maintenance of cleanrooms
  • Documentation and record-keeping requirements

Module 8: ISO 14644-1: Classification of Air Cleanliness

  • Classification of air cleanliness in cleanrooms
  • Measurement and testing methods
  • Classification of cleanrooms by airborne particulate concentration
  • Documentation and record-keeping requirements

Module 9: ISO 14644-2: Specifications for Testing and Monitoring

  • Specifications for testing and monitoring cleanrooms
  • Measurement and testing methods
  • Monitoring and control of cleanroom parameters
  • Documentation and record-keeping requirements

Module 10: ISO 14644-3: Test Methods for Cleanrooms

  • Test methods for cleanrooms
  • Air sampling and testing methods
  • Surface sampling and testing methods
  • Documentation and record-keeping requirements

Module 11: ISO 14644-4: Design, Construction, and Start-up

  • Design, construction, and start-up of cleanrooms
  • Cleanroom design and layout
  • Air filtration and circulation systems
  • Surface finishes and materials

Module 12: ISO 14644-5: Operations

  • Cleanroom operations and procedures
  • Cleaning and disinfection techniques
  • Maintenance and repair of cleanroom systems
  • Training and personnel management

Module 13: ISO 14644-6: Vocabulary

  • Vocabulary and definitions related to cleanrooms
  • Terminology and abbreviations
  • Units of measurement and conversion factors
  • Reference documents and standards

Module 14: ISO 14644-7: Separative Devices

  • Separative devices in cleanrooms
  • Types of separative devices
  • Design, construction, and testing of separative devices
  • Installation, operation, and maintenance of separative devices

Module 15: ISO 14644-8: Classification of Airborne Molecular Contamination

  • Classification of airborne molecular contamination in cleanrooms
  • Measurement and testing methods
  • Classification of cleanrooms by airborne molecular contamination concentration
  • Documentation and record-keeping requirements

Module 16: ISO 14644-9: Classification of Surface Cleanliness

  • Classification of surface cleanliness in cleanrooms
  • Measurement and testing methods
  • Classification of cleanrooms by surface cleanliness concentration
  • Documentation and record-keeping requirements

Module 17: ISO 14644-10: Classification of Cleanrooms by Airborne Particulate Concentration

  • Classification of cleanrooms by airborne particulate concentration
  • Measurement and testing methods
  • Classification of cleanrooms by airborne particulate concentration
  • Documentation and record-keeping requirements

Module 18: Cleanroom Certification and Accreditation

  • Cleanroom certification and accreditation procedures
  • Third-party certification and accreditation
  • Certification and accreditation requirements
  • Maintenance and renewal of certification and accreditation

Module 19: Cleanroom Training and Personnel Management

  • Cleanroom training and personnel management procedures
  • Training requirements for cleanroom personnel
  • Personnel management and supervision
  • Training records and documentation

Module 20: Cleanroom Documentation and Record-Keeping

  • Cleanroom documentation and record-keeping requirements
  • Types of documents and records
  • Document control and management
  • Record-keeping and storage requirements


Certification

Upon completion of the course, participants will receive a certificate issued by The Art of Service.



Course Features

  • Interactive and engaging content
  • Comprehensive and up-to-date information
  • Personalized learning experience
  • Practical and real-world applications
  • High-quality content and expert instructors
  • Certification upon completion
  • Flexible learning options
  • User-friendly and mobile-accessible platform
  • Community-driven and interactive discussion forums
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking
,
!