The Importance Of ISO Certifications For A Precision Machining Company

ISO certifications have been around for more than half a century and as of today, it’s made up of 163 member countries. In business, these certifications tell interested clients if a manufacturer is working in accordance with standards dealing with quality, management, consistency, customer service and many other areas of business. Since the creation of ISO standards, one body, composed of representatives from a variety of national standards organizations, has created and enacted them.

Brief History of the International Organizational for Standardization

The International Organization for Standardization (ISO) was created in 1947 in Geneva, Switzerland, to make standards in commerce and industry universal. Some organizations sought to do the same prior to 1947, but having multiple standard-setting organizations was impractical for universal purposes. One organization was needed so commercial and industrial standardization could be truly standardized. One set of standards by one organization, giving confidence to buyers involved in proprietary, commercial and industrial business. This is what the International Organization for Standardization achieved.

ISO 13485:2003: Standard for Quality Management System for Medical Device Manufacturing

In the world of medical device manufacturing, the ISO 13485 certification is the most important kind of certification. Without it, it’s impossible for medical equipment clients to know if they can trust the precision machining company.

Among other things, the ISO 13485 certification reveals that an organization has a quality management system that’s effectively implemented and maintained. A third-party that specializes in certifying medical device manufacturers comes in and performs a rigorous check. If the company’s operations meet the standards detailed in ISO 13485, certification is granted. This certification is typically paired with ISO 9001: 2008.

isoUnlike ISO 13485, ISO 9001 applies to manufacturers of all kinds – not just medical device manufacturers like MK Precision. Another key difference between the two standards is that ISO 13485 deals strictly with implementation and maintenance while ISO 9001 deals with continual improvement. In other words, a company that is ISO 13485-certified is a trusted provider of their advertised product while a company that is ISO 13485- and 9001-certified is both trustworthy and innovative. This truly signifies and reinforces our commitment to move towards the future of manufacturing medical devices by obtaining new equipment on a regular basis that can enhance our capabilities and services.