Original Equipment Manufacturer (OEM) compliance follows standards set by a regulatory authority in a country or state where items are sold. If OEM compliance is ignored, items cannot be sold, and disregarding those laws results in fines from countries around the world. Plus, it can destroy your company’s reputation.
Products have to be carefully tested and verified that they are safe and compatible with other products and systems. It also guarantees the item meets important regulations like food safety laws or UL requirements. They must be labeled accordingly, too.
When you work in manufacturing OEM compliance safeguards your business, but you need to understand how it applies. It’s important to understand the different standards and regulations. It’s equally important to keep up with the constantly changing global regulatory landscape as it evolves every year. Not only are there rules in the U.S., but there are also rules in the EU, Asia, and specific industries.
Key Regulations and Standards in the U.S.
Several regulations and standards are not to be overlooked. While it depends on the industry you’re in, you should make sure you’re aware of these essential ones. To remain in compliance, you need to make sure your employees, contractors, suppliers, and any outside vendors are trained in the specific regulations that apply to your business. You need to run regular assessments and audits to ensure nothing is being overlooked.
GDPR
The General Data Protection Regulation (GDPR) is one of the most important for any company to follow. This regulation is designed to protect everyone’s data. It’s essential if you build items like computers and smartphones, but it’s also important if you store customer and employee information. Data security is not something to take lightly.
ISO 9001
This is an international standard regarding quality management systems (QMS). It’s a combination of seven standards that manufacturers must follow to prove they provide services and products that meet all regulatory requirements. Not only does it ensure you meet regulations, but it also helps develop a stronger level of public trust, quality control, and productivity.
The seven standards are:
- Context of your organization
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvements
ISO 14001
While 9001 focused on quality management, this standard’s focus is on environmental management. It addresses protecting the environment and reducing a company’s environmental footprint. When you become certified in ISO 14001, you save money and reduce waste, streamline operations, lower emissions, and develop a positive reputation as an environmentally friendly company.
Also, Pay Attention to Global Regulations
In addition to federal and state regulations in the U.S., there are also global regulations for companies to follow when manufacturing items or providing necessary services to businesses and consumers.
REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)
The EU established REACH, but it’s followed around the world. Most companies use chemicals in some way, whether it’s to build rechargeable batteries, clean finished products, or clean the plant. REACH addresses the use of hazardous substances in order to protect the environment and people in nearby communities.
The list of chemicals that have to be reported and registered is long and new chemicals and substances are added each year. As of 9/20/2024, there are 241 items including:
- Arsenic
- Boric acid
- Calcium arsenate
- Coal tar
- Hydrazine
- Melamine
- Methoxyethyl acetate
- Perfluorobutane sulfonic acid,
RoHS (Restriction of Hazardous Substances)
In the U.S. and the EU, many toxic metals and other hazardous substances are restricted from landfills. They must be used carefully in new electronic and electrical devices and recycled properly when they reach their end-of-life. The list of 10 substances and limits are as follows.
- Bis (2-ethylhexyl) phthalate – Less than 1,000 parts per million
- Butyl benzyl phthalate – Less than 1,000 ppm
- Cadmium – 100 ppm maximum
- Di isobutyl phthalate – Less than 1,000 ppm
- Dibutyl phthalate – Less than 1,000 ppm
- Hexavalent chromium – Less than 1,000 ppm
- Lead – Less than 1,000 ppm
- Polybrominated biphenyls – Less than 1,000 ppm
- Polybrominated diphenyl ethers – Less than 1,000 ppm
WEEE (Waste Electrical and Electronic Equipment)
In much of the U.S., electronics like cell phones, rechargeable devices, scanners, and tablets are considered hazardous materials. They cannot go into the trash. Manufacturers may need to set up takeback programs or provide consumers with information on where to bring electronics for responsible recycling. This is another EU regulation that the U.S. adheres to.
Explore Industry-Specific Regulations
Some regulations apply to specific industries, too.
Automotive Manufacturers
The National Highway Traffic Safety Administration set Federal Motor Vehicle Safety Standards (FMVSS). They are an example of an industry-specific regulation and cover these areas:
- Crash avoidance (Brake systems, controls and dash information, headlights, indicators, mirrors, tires, transmission, and windows/windshield defrost)
- Crashworthiness (Airbags, head restraints and seatbelts in a vehicle, ejection prevention, and helmet strength for motorcyclists)
- Miscellaneous (Coolant/radiator system, low-speed vehicles, interior trunk release, and low-speed vehicles.)
- Post-crash survivability (Protection of items like gas tanks and fuel systems in a crash and flammability.
Electronics and Technology
One of the best-known OEM regulatory programs is the Energy Star program. It’s an incentive for manufacturers to make equipment that meets Energy Star requirements for energy consumption. Energy Star equipment keeps electricity and fuel consumption usage to a minimum.
There are also FCC regulations that limit things like output or usage when using a two-way radio. This is to prevent disruptions that could impact people’s safety by blocking first responders from having access to radio communications. Two-way radios must be labeled FCC-certified.
Medical Devices
The FDA protects consumers with regulations on medications, but there is more than that. ISO 13485 is one example of regulations that apply to medical equipment manufacturers. It’s a quality management regulation that covers the design and development, production, storage, and repairs of medical devices.
What Are the Best Practices for OEM Compliance?
Set up alerts for keywords that apply to your business. If you make smartphones, track news alerts for technology regulations. Make it a point to read government press releases, too. As laws change, you’ll know of them in advance.
Run regular risk assessments to catch any issues as early as possible. The use of AI is helpful here as it’s a key player in mitigating problems with compliance. Make sure any suppliers also complete regular risk assessments. If they’re not willing to do so, find a new supplier. A lower cost isn’t worth the fines and penalties you face if they’re not following regulations.
Keep track of all records. If you have outdated electronics that are being recycled, make sure you have documentation proving you followed state and federal laws for privacy protection and data security.
When you develop a system for OEM compliance that works well, chart the steps that must be followed and how to continually monitor routines to ensure changes aren’t required. Have this printed out, laminated, and available in obvious areas for all supervisors, managers, and team leaders. The information has to be available and changes addressed as soon as they’re made.
If you still aren’t sure what to do next, align your company with industry professionals. You need an expert’s guidance to ensure you do not make any costly errors.
Manufacturers have to remain compliant when it comes to certain states’ recycling programs. Take-back programs require OEMs to set up recycling programs for electronics. ERI can help you set up a program that meets federal and state regulations. Our services include:
- Certified and verifiable responsible processing
- Compliance management
- Diverse and efficient collection networks
- Efficient transportation options
- Public education tools
- State planning
- Tracking/Reporting
- Vendor auditing
With nine locations around the U.S., we provide secure transportation to the nearest facility and real-time tracking and reporting are always available. We’re happy to answer your questions and make it easy to navigate OEM compliance, contact us today!