ISO 9001:2000

Link to ISO certificate

... and what the heck does ISO 17050:2004 have to do with it?

 

For several years, manufacturers in the US have had to strip out overhead expense when value added is poor. From 2000 through 2006, an independent registrar assessed Micro Enterprises as conforming to the ISO 2002:1994, then to ISO 2001:2000 standards. The only non-conformances discovered were minor. During the same period, Micro drove its part-per-million defect rate well below 500 PPM with internally driven quality systems developed completely independently of the ISO “requirements”. We have been frustrated by the recurring and significant cost of the registration process because so little value derived from it and because the primary benefit from constant revisions to the way standards are audited accrues to the registrars themselves instead of to the patient. Registrars, remarkably, are prohibited from making best-practice recommendations. Micro's audits resulted in no measurable improvements to cost, quality, or performance, and we obviously have had to pass the registrar costs along to customers.

 

Micro's major customers were consulted to determine if a change would become an issue. Those that responded highlighted the particular value of independent, outside auditor involvement, and did not discourage exploration for an alternative approach.

 

After these extensive internal and external discussions, we discovered an interesting option: the ISO 17050:2004 standard provides for self-declaration of conformance, and is the very standard that enables manufacturers worldwide to self-declare conformance with the highly-regarded “CE” mark for safety standards covering electrical safety, RFI, medical devices, heavy machinery, electro-mechanical devices, pressure vessels, and many more.

 

Under the guidelines of ISO 17050:2004, Micro has adopted a program that utilizes an independent professional auditing service to accomplish the same assessments that have been performed by accredited registrars, and on the same intervals. Another advantage to reduced cost is that this auditor can, unlike registrars, offer recommendations for improved operating efficacy. The first audit under the new approach was more thorough and rigorous than any of the accredited registrar audits were. Review a recent audit report if interested in the findings & responses.