At MK Precision, we manufacture medical devices that are used by world-renowned healthcare providers and it takes more than advanced machining to produce such high quality products. In the manufacturing industry, it is very important to hold various certifications that give us credibility in the work we do which is why we proudly boast two certifications from the International Organization for Standardization, also known as ISO.
What is ISO?
ISO is a worldwide organization that promotes proprietary, industrial and commercial standards in 164 countries. The headquarters are located in Geneva, Switzerland where voluntary organization members are recognized as authorities on standards, and each participating country has one representative. They hold annual meetings to discuss various ISO strategies, objectives and other important certifications.
While there are various certifications that fit into a broad spectrum of industries, MK Precision holds the ISO 13485 certificate and the ISO 9001:2008 certificate.
This specific certification standard was published in 2003 and represents the requirements for a comprehensive quality management system that is used for the design and manufacture of medical devices. What this means is that MK Precision manufactures medical devices that meet high quality standards that are consistently maintained and our quality system is effectively implemented.
When it comes to designing and developing products, holding the ISO 9001:2008 certificate sets precedence because it signifies that MK Precision engages in the creation of new products. Additionally, it requires the development of manufactured products have an approval process, set of rigorous quality standards and development records before the product is distributed. This gives an extra measure of excellence to ensure manufactured materials are superior.