When choosing the best service provider for your company, quality is one of the most important factors to consider. Becoming familiar with a company’s adherence to quality management systems and their work toward improvements in efficiency and productivity can provide insights into their business ideals, ethics, and goals.
Particularly important in the medical, aerospace, industrial, and microelectronic industries, adherence to various quality standards ensures optimum product performance. As these industries are increasingly expected to provide evidence of quality management processes, it’s vital to fully understand a potential laser processing partner’s quality standards and how they will affect your company.
Certifications to Look for When Choosing a Laser Shop
Certifications issued by the International Organization for Standardization (ISO) ensure quality and efficiency of products, services, and systems while helping businesses decrease their environmental impact and cut down on expenses using streamlined systems. Because businesses across the world are held to the same standards, ISO certification is also a major factor in advancing global trade.
Finding a laser processing shop that is ISO certified ensures that all laser cutting, welding, drilling, and finishing will be done as efficiently as possible. ISO 13485, specifically, sets standards for the design and production of medical device components — a field that necessitates the utmost attention to quality.
The International Traffic in Arms Regulations (ITAR) is a U.S. government regulation that manages the import and export of defense-related products and services. Many major U.S. OEMs require suppliers to be ITAR compliant.
The Export Administration Regulations (EAR) — another U.S. government regulation — pertains to the import and export of most commercial products, many of which are “dual-use,” for both commercial and military functions. Similar to ITAR compliance requirements, the majority of U.S. OEMs mandate supplier compliance with EAR.
Originating in the European Union (EU), The Restriction of Hazardous Substances (RoHS) regulation, also known as Directive 2002/95/EC or Lead-Free, regulates the use of certain hazardous materials found in electrical and electronic products.
REACH, which stands for Registration, Evaluation, Authorization and Restriction of Chemicals, is another EU regulation. This measure aims to protect both people and the environment from chemical risks while also promoting competition in the EU chemical industry.
Laserage’s Quality Certifications
At Laserage Technology Corporation, we pride ourselves on our adherence to quality standards and strong business ethics. In fact, our quality policy dictates that we “Focus on Excellence.” We’re registered to the medical device component manufacturing ISO 13485:2003 for laser processing and assembling of medical device components and subassemblies. We conduct both internal and external audits regularly to ensure compliance to the 13485 standard as well as ISO 9001:2008 for non-medical components.
Going one step further, our global code of conduct establishes compliance with all known and applicable laws and ensures that we adhere to the highest standards of business ethics.
Learn More About Laserage
To learn more about Laserage’s certifications and how we can partner with you to complete your next medical device component laser processing project, download our Quality Standards for Laser Technology Contract Manufacturers eGuide.