In the globalised manufacturing competition, standardisation is the core means for enterprises to improve quality, reduce costs and expand markets. A series of standards formulated by the International Organisation for Standardisation (ISO) provide a scientific and systematic management framework for the manufacturing industry, helping enterprises to standardise their operations in complex production processes. The following is a compendium of common ISO standards in the manufacturing industry, analysing their core content and practical value.

ISO 9001: The universal language of quality management system

ISO 9001 is the most widely used quality management system standard in the world, applicable to all kinds of manufacturing enterprises. The core idea is to "focus on the customer", through the establishment of a documented system to regulate the whole process from product design, procurement to production and after-sales.

The standard requires enterprises to clarify the quality objectives and responsibilities of each link, and to ensure that the products meet the requirements and regulations through process control, risk assessment, continuous improvement and other mechanisms. For example, in the manufacture of automotive parts, it is necessary to audit the supplier's quality system, monitor the key parameters of production, and close the loop to deal with non-conforming products. Certification can reduce quality accidents, enhance customer trust, and help to enter the international market.

ISO 14001: Environmental Guidelines for Green Manufacturing

The ISO 14001 environmental management system standard is an important tool for the green transformation of the manufacturing industry. It focuses on the impact of production on the environment and requires the identification and control of environmental factors such as wastewater, waste gas, solid waste, energy consumption, etc., and the development of feasible objectives and programmes.

In the electronics manufacturing industry, it promotes the adoption of lead-free soldering and optimises waste recycling; in the chemical industry, it requires the establishment of an emergency response plan to prevent spills. Certification reduces the risk of environmental penalties, reduces costs through energy savings, meets the demand for "green products" and enhances brand image.

ISO 45001: A protective barrier for employee safety

The manufacturing industry is mostly involved in high-risk areas. ISO 45001 occupational health and safety management system protects employee health and safety by identifying sources of danger and establishing control measures.

Machining workshops need to be equipped with protective gear, calibrated equipment safety devices, and isolated from dust and noise; construction material companies should establish occupational health check-up systems. The implementation can reduce the loss of work injury, improve employee satisfaction and reduce the turnover rate.

ISO 13485: Specialised Assurance of Medical Device Quality

ISO 13485 is for medical device manufacturing, emphasising "process validation" and "traceability", covering the whole life cycle to ensure product safety and effectiveness.

The production of implantable devices requires full testing of raw materials, strict control of production cleanliness, and the establishment of traceability files; in-vitro diagnostic reagents need to undergo clinical trials and monitor storage and transport conditions. Certification is a necessary condition for entering the international market and a key guarantee for patient safety.

IATF 16949: Quality Benchmark for Automotive Supply Chain

IATF 16949, based on ISO 9001, is an authoritative standard for the automotive manufacturing industry, focusing on the special characteristics of the supply chain, emphasising "zero defects", and demanding high levels of product reliability and consistency.

APQP, FMEA, SPC and other tools are required to identify risks at the design stage; PPAP ensures stable mass production; and the supply chain requires multi-level quality control. For example, in new energy vehicle battery manufacturing, the consistency of the battery cell needs to be strictly tested to reduce the potential safety hazards.

ISO 3834: Professional Specification for Welding Quality

ISO 3834 is divided into four levels according to the complexity and importance of the product, and regulates the whole process of personnel qualification, equipment calibration, process evaluation and weld inspection.

In the manufacture of pressure vessels, the welding process needs to be verified, welders licensed and welds non-destructively tested; the welding of steel structures should establish a record file to record parameters in real time. Compliance can reduce the risk of scrapping and guarantee the safe operation of large equipment.

ISO 22000: A safety defence for food-related manufacturing

ISO 22000 applies to food packaging, processing equipment and other manufacturing enterprises, extending the concept of "from farm to fork", requiring the identification of the risk of contaminating food, such as raw materials hazardous substances, equipment cleanliness, personnel hygiene.

Food contact plastic packaging needs to be tested for plasticisers and heavy metals, and microorganisms in the workshop need to be monitored; processing machinery needs to be designed to be easy to clean and free of dead ends.

These standards complement each other, and companies can choose certification as needed. Standardised management improves efficiency, establishes a professional image and lays the foundation for long-term development. In the future, ISO standards will be updated in line with the trend of smart manufacturing and low-carbon production, and continue to lead the high-quality development of the manufacturing industry.