Companies in the manufacturing industry are in constant competition for marketable products. Only companies that can achieve higher levels of customer satisfaction by meeting customer needs and expectations while maintaining constant demand for their products in the local and global market are recognized as world-class manufacturers.
When entering the global market, manufacturers and their products must be legally approved and comply with regulatory standards. One of the requirements is that they have certifications. One such certification for the manufacturing industry is ISO certification. So what is ISO and what role does it play in manufacturing companies? Let's continue reading.
What are ISO and ISO standards in manufacturing?
According to the official ISO website, “ISO is an independent international non-governmental organization with 167 member states as standards bodies.”
ISO stands for International Organization for Standardization, which develops standards agreed upon by experts from various industries around the world. These international standards are called ISO standards. Currently, ISO has published 24,338 international standards.
ISO standards and other regulatory standards are developed to create a safe, clean and fair world. These standards include standards that promote social responsibility, energy efficiency and conservation, waste reduction, occupational health and safety, quality control and assurance, etc. Many ISO standards are developed for many industries, from the product manufacturing process to the supply chain, delivery, other services and organizations.
Because ISO standards are like formulas that describe best practices defined by ISO, whenever things do not work as planned, it means that there may be no standards or that existing standards are not being followed.
Why do manufacturing companies need ISO certification?
In fact, ISO certification is not issued by ISO. The certification process is carried out by third-party organizations through regular audits.
ISO certification may not be necessary, but companies with ISO certifications create a better image with customers and leave a good impression. Here are some of the best reasons why manufacturing companies need ISO certification.
Gain a competitive advantage
As ISO standards are recognized worldwide, manufacturing companies with ISO certificates have better opportunities to expand their business internationally.
If you are familiar with the World Trade Organization (WTO), this international body has many members from other countries and is responsible for implementing trade rules and regulations around the world. The rules and regulations of this international organization are based on standards created by international organizations such as ISO.
ISO certified companies are often able to expand their operations around the world due to their compliance and quality products, although there is significant competition between ISO certified and non-ISO certified companies at the local level.
Recognition by government and legislation
ISO is a non-governmental organization and adoption of ISO standards is voluntary. However, some ISO members who approve ISO standards are members of each country's government. These government members are also members of each country that issues its national standards. Some members issue regional standards. Some countries impose rules and regulations for the manufacturing industry and for these companies' products, which are based on ISO standards and are sometimes adapted to the standard.
Increase sales and sales
Some manufacturers may believe that obtaining ISO certification will increase the cost of doing business. Other manufacturers may also believe that adopting ISO standards means more stringent quality control and assurance, which increases the budget for their manufacturing process.
However, ISO certification offers numerous benefits to increase a company's sales and revenue.
ISO standards better help the manufacturing industry to avoid fewer errors in the manufacturing process, which leads to better product quality and continuous improvement in the manufacturing process. Continuous improvement of the process and product quality leads to cost reduction. Or, better yet, it can eliminate defective parts and avoid downtime in the manufacturing process.
Reducing costs and increasing efficiency naturally increases sales for any manufacturing company. And quality products generate more orders and, therefore, greater sales.
5 common ISO standards for manufacturing
ISO has developed 24,338 international standards. There are 5 general standards used for manufacturing and have a certification process.
ISO 9001 Certification
ISO 9001 is an ISO standard from the ISO 9000 family. This standard is the most popular standard in the ISO 9000 family and also the most popular in various industries. ISO 9001 contains the requirements for a quality management system (QMS).
The most recent version of ISO 9001 is ISO 9001:2015 Quality Management Systems – Requirements.
ISO 9001 explains the 7 quality management principles (QMP). These 7 QMPs form the core of the QMS, as they provide guidance for the continuous improvement of your organization. However, these principles are not mandatory, just a guide for your company or organization. It still depends on your company's needs. The 7 QMPs are listed below.
Principle 1: Customer focus
Principle 2: Leadership
Principle 3: Engaging people
Principle 4: Process Approach
Principle 5: Improvement
Principle 6: Fact-based decision making
Principle 7: Relationship management
Below is a summary of the contents of ISO 9001, as well as some basic information about how it should be applied by organizations. By the way, ISO 9001 does not provide step-by-step instructions on how to run your business, but rather creative ways on how to run your business.
PDCA Cycle – As international standards promote the process approach, the Plan-Do-Check-Act cycle must be applied to all processes in the organization to consistently meet customer requirements. In this, all continuous improvements are applied harmoniously to achieve the effectiveness and efficiency of the organization's performance. This must be presented through evaluated data and information. Process integration is one of the main points of ISO 9001.
Risk-based thinking – From the transition from ISO 9001:2008 to ISO 9001:2015, risk-based thinking is one of the new terms included in this review. Risk-based thinking is an advanced preventative measure. With any problem that arises, both risks and opportunities must be considered.
Strengths, weaknesses, threats and opportunities are analyzed across all elements of the organization to promote continuous improvement. Root cause analysis of nonconformities and corrective actions must be performed while continually monitoring effectiveness.
Some companies preparing for ISO 9001:2015 certification are required to have documents or procedures that demonstrate they practice risk-based thinking. One of them is failure mode and effects analysis (FMEA).
Quality standards, inspection and quality control – Dimensional and functional specifications of customer requirements were achieved through the establishment of quality standards and quality control and inspection procedures.
Continuous improvement – Continuous improvement should be a top priority for top management.
documentation – The necessary processes, procedures, work instructions, forms and checklists must be properly documented.
Most industries apply ISO 9001. For some critical and complex products such as However, a separate regulatory standard typically applies to certain types of equipment such as medical devices, automobiles, etc.
ISO 13485
ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. This standard also deals with a quality management system very similar to ISO 9001. However, the production of medical devices must comply with applicable regulations, as most medical devices require CE marking.
IATF16949:2016
ISO/TS 16949:2009 Quality management systems – The specific requirements for the application of ISO 9001:2008 to automotive production and the corresponding service parts organization are currently being changed to IATF 16949:2016. This is a global automotive industry standard that is almost identical to ISO 9001. Automotive products are among the complex products to which this regulatory standard applies.
ISO 14001 Certification
From the family of environmental management standards comes ISO 14001:2015 Environmental Management Systems – Requirements for Use as a Guide (EMS), which aims to help an organization develop a systematic approach to managing environmental problems by integrating them into the organization's processes . to integrate.
ISO 14001 ensures regulatory compliance for industrial companies. Companies that integrate this standard into their processes benefit from benefits such as less waste, air pollution, water consumption and climate protection. There is a separate standard for energy management system called ISO 50001. This standard is also one of the regulatory standards.
By considering the life cycle of manufactured products, ISO 14001 also contributes to sustainable development.
The section titles of ISO 14001 are the same as those of ISO 9001, but of course the content is different. However, ISO 14001 has 10 sections while ISO 9001 has 11 sections because performance assessment is not included in ISO 14001. Both standards apply the PDCA framework.
ISO 45001 Certification
The current version of this standard is ISO 45001:2008 Occupational health and safety management system – Requirements with guidance for use (SSO). Occupational safety management, like EMS, is regulatory. ISO 45001 is a standard that can help protect the health and safety of all employees and anyone else entering an organization's premises. When an organization introduces this standard into its processes, there is an increased risk of accidents, dangers and illnesses.
What certifications are typically required for manufacturing other than ISO?
CE Marked/UKCA Marked – This certification means that products with this certification are safe to use. Products sold in Europe and the United Kingdom require this certification.
RoHS – Products and other materials used in manufacturing must comply with RoHS.
UL Certification – Household products and often electronic parts of household appliances require a UL marking.
What are the benefits of ISO certification?
Below are the key benefits of ISO certified organizations for manufacturers and customers.
For manufacturers:
Increase customer satisfaction and acquire new customers
A principle of the ISO standard is customer orientation. Therefore, all processes in an organization are integrated with customer requirements. For this reason, an ISO certified organization is highly recommended by its satisfied customers.
As ISO is known internationally, ISO certification serves as an attractive business strategy for companies to attract potential customers.
Reduce risks
ISO standards require organizations to maintain the effectiveness and efficiency of the quality management system and continually improve processes in an organization. This identifies risk factors and prevents possible future problems.
Earn profits through cost savings, improved processes, organizational efficiency and increased productivity.
ISO standards recommend improving processes and identifying numerous factors that can lead to future problems, thus reducing the number of non-conforming products in production and when delivered to customers. Reducing waste means additional profits. Improved processes also speed up operations and deliveries, and the total number of workers required can also be reduced. Time savings and fewer workers mean additional cost savings for a company.
Increase efficiency
The efficiency of a QMS is closely related to an efficient workforce. ISO standards promote the safety and relevance of the workforce, making employees highly motivated, productive and efficient in their role in an organization. An ISO certified organization also means that highly competent employees work to deliver quality products.
For customers:
Guarantee of quality products.
Customers can be assured that they are purchasing safe, high-quality products from ISO-certified organizations. Customers can also rest assured that the competent ISO-certified organization not only focuses on producing goods, but also contributes to saving the environment and energy and protecting employees' labor rights.
Better product experience.
As an ISO certified company makes continuous improvements, products also continually improve over time to provide customers with a better experience and consistent satisfaction.
Good partnership.
ISO standards promote better communication and customer-centric relationships. Therefore, customers of ISO organizations can be assured that they will openly communicate their desires and requirements to manufacturers.
Get services from certified manufacturers
ISO (International Organization for Standardization) encourages companies to ensure quality in all processes using systematic plans and goals to meet customer requirements, while preventing and reducing common errors and risks in a company.
ISO certification is voluntary and may not be a requirement. However, an ISO certified organization still has higher quality and credibility compared to a non-ISO certified organization. Some local regulations that the government imposes on companies are also based on ISO standards.
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Common questions
What is ISO manufacturing?
ISO in manufacturing is the key to a successful management system and customer satisfaction.
What is the latest ISO standard?
ISO publishes the latest update to the ISO standard, which can be found on its website. According to the review, the latest ISO standard published in February 2022 is ISO/IEC 27002:2022 Information security, cybersecurity and data protection – Information security controls.
Why should your rapid prototyping supplier be ISO certified?
Like other manufacturing companies, rapid prototyping suppliers must be ISO certified to ensure the quality of the products manufactured and to be as competitive as other ISO certified manufacturers.
