ISO, the International Organization for Standardization, has been developing and publishing global standards since 1946 to help organizations improve productivity, reduce risk and streamline operations. According to the official ISO website, there are now more than 26,000 standards covering almost all aspects of technology, management and manufacturing.
For manufacturers, ISO standards play a critical role in quality, safety, efficiency and consistency. They also help manufacturing firms meet local and international standards and regulatory requirements, allowing companies to better serve customers worldwide.
Some of the most relevant standards for manufacturing include ISO 9001 (Quality Management Systems), ISO 14001 (Environmental Management) and ISO 45001 (Operational Health and Safety).
Here’s a look at ISO basics, benefits and best practices for implementation.
Understanding ISO standards
While ISO is the short form of the organization, it’s not an acronym. Instead, “ISO” is tied to the Greek work isos, which means “equal”. This is the core of ISO’s missions—creating standards that ensure consistency and equity.
To develop these standards, ISO relies on groups of technical experts, called committees. At its inception, ISO had 67 technical committees. Today, it has 829 These technical committees identify common challenges across industries and processes and then create broadly applicable solutions to these challenges.
It’s worth noting that ISO standards are voluntary. This means that unlike regulations such as GDPR for international operations or OSHA obligations in the United States, manufacturers are not required to adopt or comply with ISO standards. In practice, however, there are two compelling reasons for companies to adopt applicable ISO frameworks.
First, ISO standards have been refined over decades to optimize key manufacturing processes. This creates a “common language” for manufacturers. For example, ISO 9001 identifies seven quality management principles to help companies improve performance and solve operational issues, and these principles apply regardless of location or production type. Today, more than 1 million ISO 9001 certificates have been issued across 189 countries, making ISO the most widely used quality management standard in the world.
Second, while ISO standards are voluntary, they may be part of more comprehensive compliance requirements. For example, the FDA requires any firms that manufacture medical devices in the United States to comply with the Quality Management System Regulation (QMSR) Final Rule, which incorporates ISO 13485:2016, Medical Devices.
Key ISO standards in manufacturing
As noted above, three ISO standards are commonly used in manufacturing. They are:
- ISO 9001 (Quality Management Systems): ISO 9001 is the most widely used manufacturing standard, driving continuous improvement, defect improvement and customer satisfaction.
- ISO 14001 (Environmental Management): ISO 14001 prioritizes the reduction of environmental impacts and the development of sustainability best practices.
- ISO 45001 (Occupational Health and Safety): ISO 45001 looks to improve workplace safety, reduce operational risks, and ensure compliance with health and safety regulations.
There are also sector-specific ISO standards, such as:
- ISO 13485: ISO 13485 covers medical devices. It establishes requirements for design, development, production and service of medical devices.
- ISO 50001: ISO 50001 focuses on energy management. This standard requires companies to develop policies for more efficient use of energy and fix targets and objectives that help meet policy goals.
- ISO/TS 16949: Finally, ISO/TS 16949 is designed with the automotive industry in mind. It offers a specialized quality management system for automotive manufacturing companies.
Benefits of ISO certification
Implementing ISO standards across your organization offers multiple benefits, including:
- Improved product quality and consistency: ISO standards prioritize consistency and quality control in manufacturing. As noted by the ISO website, the goal of the organization is bringing together experts from across the world to agree on the best way of doing things.
Finding this best way involves multiple iterations and interactions across technical committees until unified standards are reached.
For example, ISO 9001 provides extensive guidance to help evaluate and select suppliers capable of meeting materials quality requirements. This helps ensure that manufactured products meet or exceed manufacturing expectations.
- Increased operational efficiency and reduced waste: Applying ISO standards can also help improve efficiency and reduce waste. Part of ISO 14001 targets waste reduction by identifying key performance indicators (KPIs) that measure the amount and type of waste produced and defining strategies to improve waste handling.
- Better risk management and compliance with regulations: Implementing ISO 45001 standards enhances workplace safety by reducing the risk of accidents. This, in turn, helps improve compliance with regulations from agencies such as OSHA. One key requirement of ISO 45001 is the development of a written health and safety policy that shows worker and management responsibilities, and allocates resources to improve production line processes, materials handling operations and industrial maintenance safety.
- Enhanced customer trust and credibility: Ongoing ISO compliance signals a commitment to transparency and continuous improvement. Consider a potential client in the process of selecting a manufacturing partner. ISO alignment may be the deciding factor—compliance with ISO 9001, ISO 14001 and ISO 45001 demonstrates a commitment to continuous improvement and operational transparency.
- Global market access and competitive advantage: Because ISO standards are created by technical committees comprised of experts from across the globe, they are applicable worldwide. This means that ISO standards are the same regardless of country or government, making it easier for manufacturers to access global markets and gain a competitive advantage.
- Internal cultural shifts toward continuous improvement: Consistent application of ISO standards helps shift internal culture toward continuous improvement. For many manufacturers, familiarity defines function: If processes aren’t explicitly broken, changes are rarely made.
ISO requires companies to evaluate existing processes and find more efficient alternatives. Over time, this helps encourage a workplace culture that prioritizes improvement over the status quo.
The benefits of ISO certification are both tangible and intangible. For example, tangible benefits may include reduced cycle time as ISO processes improve performance. Intangible benefits, meanwhile, may take the form of improved staff and customer satisfaction.
Steps to achieve ISO certification
There are five common steps in ISO certification:
1. Gap analysis
First is gap analysis. This is an assessment of current operations and how close (or far) they fall from ISO expectations. Gap analysis is critical, both for identifying the type(s) of ISO standards that best suit your business and determining where you need to invest the most time and effort.
2. Process documentation
Next is process documentation. In this step, front-line staff and managers collect documentation on all manufacturing processes. Ideally, this documentation should be stored in a centralized database for ease of access.
3. Staff training
With gaps identified and processes documented, you can begin staff training using documentation from ISO along with assistance from third-party partners or consultants. By providing staff with the tools and training they need, they can begin implementing new policies that align with ISO requirements.
4. Internal audits
Once new processes are in place, it’s time to carry out internal evaluations, which include materials, operations, safety, and industrial maintenance audits. These audits leverage ISO frameworks to compare operations with expectations. If deficiencies are identified, they can be addressed before certification audits occur.
5. Certification audits
Finally, you need to hire an approved third party to carry out a certification audit. ISO sets the standards but does not conduct audits; certification is handled by approved third-party organizations.
Once the audit is complete, the auditor sends the results to ISO. If your organization has satisfied the standards requirements, you are awarded certification.
The role of staff and management in standards compliance
Both management teams and employees play key roles in ISO certification. On the management side, having at least one C-suite sponsor helps ensure that ISO efforts receive the time, resources, and budgets required. When it comes to employees, meanwhile, it’s critical to bring them on board as soon as possible. Ideally, manufacturers should consult with staff before starting the certification process. This helps identify areas for improvement and pinpoint potential roadblocks.
It’s also important to note that ISO certification is an ongoing process. For example, ISO 9001 requires both an initial audit and regular surveillance audits once per year.
The future of ISO in manufacturing
ISO standards are continually evolving. Consider ISO 9001. The standard was last revised in 2015 and is often written as ISO 9001:2015. In 2023, ISO reached a consensus that the standard required updating, and this process is ongoing. When the new standard is released, companies will need to recertify if they want to ensure compliance.
Much of ISO’s focus for manufacturing is tied to Industry 4.0. For example, the rising use of digital twins—virtual representations of real products or components—can help companies identify quality issues more quickly and with fewer disruptions to production line performance.
Areas of focus for next-generation ISO standards include:
- Sustainability: As consumers put greater emphasis on environmentally friendly operations, manufacturing clients are looking for partners capable of meeting sustainability goals. Expect new ISO documentation to include additional KPIs to help measure and manage environmental impact.
- Cybersecurity: With many ICS and SCADA systems now connected to internet-facing IIoT networks, cybersecurity is a critical concern for manufacturers. As a result, ISO standards will place increasing emphasis on both physical and digital security measures.
- Risk management: Finally, the interconnected nature of manufacturing systems has created the need for enhanced risk management processes. While many organizations already have rudimentary systems in place, ISO will likely adopt standards that include greater emphasis on scenario planning and harm reduction.
Importance of ISO certification
ISO standards empower manufacturers to elevate quality, boost safety and optimize performance across operations. Compliance with these standards also positions companies for long-term success both at home and abroad as more customers, contractors and government organizations require ISO certification.
While ISO standards are not mandatory, they play a key role in keeping your company competitive and paving the way for efficient processes that align with Industry 4.0 expectations.
Ready to explore the benefits of ISO for your organization? Start with an assessment: See what’s working and identify what needs to change. Then, explore tools and partners that can help, such as integrated management systems to streamline processes and knowledgeable industry partners to help you prepare for ISO audits.
ISO standards are now integral to ensure manufacturing compliance and gain a competitive edge. Ready to implement ISO standards? Connect with ATS to get started.
References
International Organization for Standardization. (n.d.). About ISO. https://www.iso.org/about
International Organization for Standardization. (2015). Quality management systems—Requirements (ISO 9001:2015). https://www.iso.org/standard/62085.html
U.S. Food and Drug Administration. (2024, January 31). Overview of device regulation. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
