What industry-specific standards and regulations govern manufacturing documentation?

Manufacturing documentation is subject to a myriad of industry-specific standards and regulations to ensure product safety, quality, and compliance with legal requirements. These standards vary by region and product type, and adhering to them is crucial for manufacturers. Some prominent industry-specific standards and regulations that govern manufacturing documentation include:

ISO 9001: Quality Management Systems

ISO 9001 is an internationally recognized standard for quality management systems. It sets requirements for a quality management system, including documentation of processes and procedures. Manufacturers must adhere to ISO 9001 to ensure the quality of their products, and this includes maintaining comprehensive documentation to support quality processes.

ASME Y14 Series: Engineering Documentation and Drawings

The American Society of Mechanical Engineers (ASME) Y14 series standards govern engineering documentation and drawings. These standards specify how engineering drawings and related documentation should be created and maintained, ensuring consistency and accuracy in manufacturing. Compliance with ASME Y14 standards is essential in industries such as aerospace and defense.

OSHA Regulations: Occupational Safety and Health Administration

The Occupational Safety and Health Administration (OSHA) in the United States sets regulations to ensure safe working environments. Manufacturers must adhere to OSHA standards to protect workers’ safety. Compliance requires comprehensive documentation of safety procedures and practices.


Here’s an example of how compliance with industry-specific standards like ISO 9001 is documented:

<document id="quality_manual">
  <title>Quality Management Manual</title>
  <standard>ISO 9001</standard>

In this DITA document, the “Quality Management Manual” is created to comply with the ISO 9001 standard. The document details quality management procedures and practices required for manufacturing. This serves as a foundational element in adhering to industry-specific standards.