Monthly Archives: April 2013

ISO/TS Standards Exclusions

Question: I have a question regarding exclusions from the ISO/TS standards. The majority of our business is the design and manufacture of enclosure hardware. Recently though, a small portion of our business has become the sole North American Distributor for … Continue reading

Posted in ISO 9001 - Quality Management Systems, TS16949 - Automobiles | Tagged , , , | 1 Comment

Audit by exception

Question: I would like information regarding the use of the internal auditing method referred to as “audit by exception”. While this method sounds like it may provide a much more efficient use of my time and my Manager’s/employees time, I … Continue reading

Posted in Audit by Exception, Auditing, ISO 9001 - Quality Management Systems | Tagged , , | 1 Comment

ISO 9001:2008 Requirement for Control and Monitoring of Measurement Equipment

Inquiry: I am trying to clearly understand the  ISO 9001:2008 requirement for Control and Monitoring of Measurement Equipment.  My question: If a measurement equipment like a Karl Fisher Titrator or pH meter which is calibrated by the user with a … Continue reading

Posted in ISO 9001 - Quality Management Systems, Measuring | Tagged , , | 1 Comment

Measurement System Analysis

Question: Is there ever an exception to the rule about needing full Measurement System Analysis for any instrument placed in the Evaluation / Measurement Technique column on the Control Plan?  If an instrument is listed on the control plan, does … Continue reading

Posted in ISO 9001 - Quality Management Systems, Measuring, TS16949 - Automobiles | Tagged , , , , | 1 Comment

AS9100C

Question: Question: The AS9100C, which is an expansion of the ISO 9001:2008, states that a “process” based system is being promoted as is shown in 0.2 of the Introduction.  Why are 3rd party auditors being required to use the AS9101 … Continue reading

Posted in AS9100 - Aerospace, ISO 9001 - Quality Management Systems, Other

SIPOC

I’m working on a green belt certification. I got a question about SIPOC.  What would be the examples of inputs for hospital test facility-Supplier and the Dr and patient is customer? Response: Supplier – Doctor Input= blood sample, urine sample, … Continue reading

Posted in SIPOC, Six Sigma | 1 Comment