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norms and standards

What is meant by norms and standards?

The term "standards and norms" refers to established guidelines, specifications, and technical rules that regulate products, processes, or services. They serve as a basis for quality assurance, safety, compatibility, and efficiency across various industries. Standards and norms are often developed and published by official organizations such as ISO (International Organization for Standardization), DIN (German Institute for Standardization), or EN (European Standards). In companies, they help establish uniform processes and ensure that products and services meet international requirements.

Typical software functions in the area of "standards and norms":

  1. Standards Management: Organizing and managing standards, including version control and updates.
  2. Compliance Checking: Verifying products, processes, or documents for compliance with applicable standards and norms.
  3. Automated Standards Updates: Automatic updating and notification of changes in relevant standards and norms.
  4. Documentation and Tracking: Recording and managing compliance proofs, test reports, and certificates.
  5. Training and Information Provision: Providing training materials and resources for compliance with standards.
  6. Integration into Development Processes: Incorporating standards and norms requirements into design, development, and manufacturing processes.
  7. Risk Analysis and Deviation Management: Identifying and managing deviations from standards and their impact on production or quality.
  8. Audit and Inspection Support: Assisting in the preparation and execution of internal and external audits related to standards compliance.

Examples of "standards and norms":

  1. ISO 9001: Standard for quality management systems that sets requirements for company processes.
  2. DIN EN 10204: Standard for documenting material testing and conformity certificates for steel products.
  3. ISO 14001: Environmental management standard that describes requirements for environmental management systems.
  4. CE Marking: European standard for product certification concerning safety, health, and environmental protection.
  5. IEC 60601: International standard for the safety and performance of medical devices.
  6. REACH Regulation: EU regulation for the registration, evaluation, authorization, and restriction of chemical substances.
  7. EN 1090: Standard for the execution of steel and aluminum structures, particularly for CE marking of construction products.
  8. GMP (Good Manufacturing Practice): Guidelines ensuring quality assurance in the production of pharmaceuticals and food products.

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The function / module norms and standards belongs to:

Quality management

Software solutions with function or module norms and standards:

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eDMS | eQMS | eTMF| Solutions for quality and compliance processes
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Solution for implementing the Supply Chain Due Diligence Act (LkSG)
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The Product Innovation Platform for the optimal design of the product development process
iqs CAQ Solutions – synonymous with quality.
Show all 34 programs with norms and standards