2011/06/09日本、非洲、亚洲、欧洲、中东、北美、大洋洲、中南美
Welcome back to Under the Hood: Tips, Trends and Resources for OEMs. We have been discussing the critical importance of improving quality and error reduction in the manufacturing process. Error proofing is obviously of importance in all companies, but in particular to Medical Device, Life Science, Industrial Automation, and Aerospace & Defense OEMs whose products, devices and instruments are utilized in critical and life saving situations. Our last issue defined Poka-Yoke (an error prevention technique developed in Japan by Shigeo Shingō). In this issue we continue our detailed examination of what tools are available to OEMs for reducing errors in the manufacturing process. This naturally leads the topic to ISO certifications. While for some companies ISO may be just a good practice, for OEMs with instruments and devices require regulatory certifications, ISO certs are a necessity.
It would be a misnomer to call ISO certs a tool. That implies it is one item; when in reality it is a collection of methodologies that when implemented correctly will result in higher quality and excellence of operations. So what are the primary ISO certs that OEMs with long-life, regulated device and instruments have in place?
Naturally the first is one everyone knows (and hopefully has in place); ISO 9001. The UnØMktr (aka the UnKnown Marketer) thought the best place for a definition would be the ISO organization itself; so directly from ISO.org: “ISO 9001:2008 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.”
While I was searching for resources, I noticed something interesting. There were multiple ways this certification is referenced that, in my opinion, can be a source of confusion (ISO 9000 & ISO 9001 to reference a few). But, I also found a nice clarification on praxiom.com : “The term ISO 9000 unfortunately has two different meanings: it refers to a single standard (ISO 9000) and it refers to a set of three standards (ISO 9000, ISO 9001, and ISO 9004). All three are referred to as quality management system standards.”
While the benefits of ISO 9001 certification and implementation are going to vary from company to company, there are some universal benefits to be gained:
Join us for our next issue as we continue our series on bringing quality excellence to your OEM manufacturing process and look at ISO 13485:2003 certification. And since everybody can use a laugh, regardless of how serious you are, the UnØMktr leaves you with this gem:
Contec is a Systems Integrator focused on delivering cost effective and high reliability computing and displays solutions for OEMS in the Medical, Industrial, and Military, Aerospace & Government industries who require a customized, long life solution. Contec offers an expansive product line including: embedded computers & customized computing solutions; control, DAQ & monitoring systems, advanced touchscreen displays (medical, industrial & commercial grade); All-in-One (AIO) panel PCs; and a wide variety of handheld tablets and laptops. But Contec offers more than just products. For over 20 years we have developed long-term partnerships with our customers. In our total solutions approach we provide Solution Engineering, Project Management, Global Logistics & Supply Chain, Lean Manufacturing, Product Life Cycle Management (PLM), and Post Production Support services.
See you next time,
the UnØMktr
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