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ElectroStat: an ISO / IEC 17021, ISO 19011 and IATF-Approved Company




In February 2007, a new version of the ANSI/ESD S20.20 was published, while the new IEC 61340-5-1 and IEC 61340-5-2 are being printed at the moment. The IEC 61340-5-3 is proposed to be sent to the members of the IEC / TC 101, who will have until the end of March to give their remarks. The final vote is expected to be in June 2007 during the IEC / TC 101 meeting in Japan. ElectroStat's Vincent Neel is an IPC certified ESD-instructor, and a member of the ESD Association. A lot of new or revised papers and presentations can be found at www.es-electrostat.com/downloads.htm. ELECTROSTAT MEETS ISO / IEC 17021 and ISO 19011 REQUIREMENTS At the beginning of the year ElectroStat started a new service, which can be seen at www.es-electrostat.com/quality_management.htm. Until now, one of the biggest problems organisations had with the implementation of the ISO/TS 16949:2002 was the requirement that all suppliers had to be certified to ISO 9001:2000 by an accredited third party certification body (ยง7.4.1.2). This caused a difficulty, as a lot of organisations co-operate with little pop and mom shops. Only suppliers to Ford had the possibility to approve suppliers without this certification, as long as the STA agreed with the audit and the auditor. In December the IAOB published a new sanctioned interpretation (viewable at www.iaob.org/showPage.php?title=ISO/TS 16949:2002 7.4.1.2 Supplier quality management system development), which allows organisations to release suppliers without an ISO 9001 certificate if the organisation performs second party audits and the applicable standards (ISO / IEC 17021 and ISO 19011), are met. ElectroStat fulfils all these requirements, and can therefore approve your suppliers without an ISO 9001 certificate. AN IATF-APPROVED COMPANY A second problem that organisations have is the qualification of the internal auditors. Although there are no formal rules about this, a lot of external auditors have their own opinion and write deviations if the internal auditors are not qualified by one of the IATF bodies. ElectroStat, by contrast, has the written approval of an IATF body to provide such training and to write certifications. The beginning of the year is a time when a lot of organisations audit their archives and review their procedure about record retention. We want to inform our customers that some OEMs are planning to switch the retention time of documents regarding product integrity from 15 to 20 years. We also want to inform our Belgian customers that the legal retention time for financial data has decreased from ten to seven years.


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[Clinical Trials] Brightness, Contrast, and Color Balance of Digital versus Film Retinal Images in the Age-Related Eye Disease Study 2

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methods. The Age-Related Eye Disease Study 2 (AREDS2) is enrolling subjects from 90 clinics, with three quarters of them using digital and one quarter using film cameras. Image brightness (B), contrast (C), and color balance (CB) were measured with three-color luminance histograms. First, the exemplars (film and digital) from expert groups were analyzed, and an AMD-oriented model was constructed. Second, the impact of B/C/CB on the appearance of typical AMD abnormalities was analyzed. Third, B/C/CB in AREDS2 images were compared between film (156 eyes) and digital (605 eyes), and against the model. Fourth, suboptimal images were enhanced by adjusting B/C/CB to bring them into accord with model parameters.

results. Exemplar images had similar brightness, contrast, and color balance, supporting an image model. Varying a specimen image through a wide range of B/C/CB revealed greatest contrast of drusen and pigment abnormalities against normal retinal pigment epithelium with the model parameters. AREDS2 digital images were more variable than film, with lower correspondence to our model. Ten percent of digital were too dim and 19% too bright (oversaturated), versus 1% and 4% of film, respectively. On average, digital had lower green channel contrast (giving less retinal detail) than film. Overly red color balance (weaker green) was observed in 23% of digital versus 8% of film. About half of digital (but fewer film) images required enhancement before AMD grading. After optimization of both image types, AREDS2 image quality was judged as good as that in AREDS (all film).

conclusions. A histogram-based model, derived from exemplars, provides a pragmatic guide for image analysis and enhancement. In AREDS2, the best digital images matched the best film. Overall, however, digital provided lower contrast of retinal detail. Digital images taken with higher G-to-R ratio showed better brightness and contrast management. Optimization of images in the multicenter study helps standardize documentation of AMD (ClinicalTrials.gov NCT00345176).

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