Understanding ISO Standards for Manufacturing

What are ISO Standards for Manufacturing?

The International Organization for Standardization (ISO) is a globally recognized nongovernmental organization that develops a wide range of industrial, commercial, and proprietary standards. ISO guidelines are implemented across different industries to drive innovation and ensure the safety, quality, and efficiency of operations through recognized certification. In manufacturing, ISO certification guarantees that a service, process, system, or product follows proper regulations to ensure safety and quality throughout production.

Importance

Product reliability and quality are some of the most important consumer considerations, and these factors also greatly affect a manufacturing company’s reputation. As such, it is crucial for organizations to have ISO certification—this ensures that the production process is organized, implements safe practices for workers, and adheres to quality standards across different industry niches.

Moreover, manufacturing is considered one of the most regulated industries, especially pharmaceuticals and food and beverage products. Following ISO standards decreases the risk of producing poor-quality products, which could potentially harm consumers and initiate product recalls. In the US alone, product recalls surged by 11% in 2023, while the European Union (EU) saw an 18.5% increase for the same issue.

An ISO certification essentially increases business credibility and improves production practices to yield quality products.

Common ISO Standards Used in Manufacturing

The ISO standards are widely used across different industries around the world and there are numerous guidelines that exist to accommodate various processes. As such, some can be narrowed down to the manufacturing industry and here are a few examples:

ISO 9001

ISO 9001 is a standard that outlines guidelines organizations must follow for auditing management systems. It is primarily focused on managing audits conducted to ensure it aligns with safety policies and objectives.

Additionally, this standard encourages accountability by considering consumer demand and other stakeholders to improve the quality of products and manufacturing processes.

ISO 45001

ISO 45001 is widely regarded as an international standard for occupational health and safety. Holding certification for this standard means an organization is able to develop risk mitigation strategies to promote workplace safety and have the proper measures in place to address inherent hazards in certain work activities.

This is especially relevant in the manufacturing industry, as some production processes come with inherent risks. With this standard, manufacturers can initiate globally recognized safety measures through proper training, routine equipment inspections, and proper protective equipment to keep workers safe.

ISO 14001

ISO 14001 is a standard that primarily concerns environmental safety by providing a framework organizations can follow to practice sustainability within their operations. By following this standard, organizations display dedication to reducing environmental impact and encourage legal compliance with emerging legislation that aims to fulfill sustainable practices.

Aspects of this framework include better waste management, finding sustainable alternatives to raw materials in production, and long-term planning to ensure environmental compatibility.

ISO 50001

In line with the previous standard, ISO 50001 also touches on sustainability through its focus on energy management. This standard encourages organizations to develop policies for more efficient energy use and simultaneously reduce their carbon or greenhouse gas emissions.

Industry or Material Specific Standards

Manufacturing covers a broad range of industries that use different materials or follow specific ISO standards based on their production processes. Here are some examples:

• ISO 10204 – This specifies a flame atomic absorption spectrometric method for determining the mass fraction of magnesium in iron ores. It is most relevant in welding processes and the production of metal used for construction.

• ISO 13485 – This standard is meant for manufacturers and suppliers of medical devices and outlines consistent design, development, production, and delivery of medical devices that are safe for their intended purpose. This is also supported by ISO 17664, which requires manufacturers to ensure every device is fully sterilized before delivery.

• ISO 25.x family of certificates – These standards are clustered together, as they relate to manufacturing engineering. These are instrumental in manufacturing processes by ensuring high levels of precision and quality throughout different production stages.

• ISO 22000 – This standard is crucial for food and beverage manufacturers. It is primarily a framework for creating an effective food safety management system to ensure food products meet the proper regulatory requirements.

Best Practices for ISO Compliance in Manufacturing

Achieving and maintaining ISO compliance in manufacturing involves adhering to best practices that ensure quality, consistency, and continuous improvement. Here are some key best practices:

• Understand Applicable ISO Standards: Identify the relevant standards needed for manufacturing processes to know the requirements that will define operational goals.

• Establish a Strong Quality Management System (QMS): Develop policies, procedures, and processes aligned with the ISO standard and use a process-based approach to manage interrelated activities effectively.

• Train Employees: Conduct regular training sessions to familiarize staff with ISO requirements and procedures. This also promotes a culture of quality awareness and accountability at all organizational levels.

• Perform Regular Internal Audits: Schedule routine internal audits to evaluate compliance with ISO requirements, identify non-conformities, and take corrective actions promptly.

• Monitor and Measure Performance: Set key performance indicators (KPIs) relevant to your ISO standard. Use metrics like defect rates, production efficiency, and customer satisfaction to track performance.

• Focus on Continuous Improvement: Use tools like PDCA (Plan-Do-Check-Act) cycles for ongoing improvement. Also, implement feedback mechanisms for employees and customers to identify areas for enhancement.