June, 2007 Newsletter Articles

TL 9000 R4.0 Requirements

Jun 8, 2007 in Newsletter | 0 comments

The TL 9000 standard (based on ISO 9001:2000) specifies requirements for suppliers of telecommunications products: hardware, software, and/or services. A summary document that identifies the unique TL 9000 Release 4.0 requirements has been placed in the Resources section of our web site. The ISO 9001:2000 clause numbers and titles have been boxed in the text to set them off from the TL 9000 R4.0 requirements. The ISO 9001:2000 requirements were not included since the focus of the document is on the TL 9000 R4.0 adders. TL 9000 identifies its...

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ASME Measurement Uncertainty Standard

Jun 8, 2007 in Newsletter | 0 comments

The National Institute of Standards and Technology (NIST) engineers, together with colleagues from industry and other standards organizations, have completed a five-part series of standards designed to evaluate the accuracy and usability of manufacturing measurements. The American Society of Mechanical Engineers (ASME) recently published the last in the series, B89.7.3.2 – 2007, Guidelines for the Evaluation of Dimensional Measurement Uncertainty. A copy can be obtained for $35.00. Click on the title above to go to its ASME Product...

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ISO 9001:2009 – Clause 7 Changes

Jun 8, 2007 in Newsletter | 0 comments

In the last newsletter, I reviewed the proposed changes for clauses 5 and 6 of the draft ISO 9001:2009 standard. This month, we’ll look at the suggested changes for clause 7, Product Realization. 7.1 Planning of Product Realization The only change to the text of clause 7.1 is the addition of “measurement” as one of the required activities to be determined during the planning of product realization. In planning product realization, the organization shall determine the following, as appropriate: c) required verification,...

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FMEA Quality Tool

Jun 8, 2007 in Newsletter | 0 comments

Have you heard about FMEA, but remain unsure of its use as a quality tool? Well, FMEA is the acronym for Failure Modes and Effects Analysis. Failure Modes are the ways in which something might fail. The failures are actual or potential errors or defects, especially those affecting the customer. Effects Analysis refers to studying the consequences or effects of those failures. Failures are prioritized according to the seriousness of their consequences, the frequency of their occurrence, and likelihood of their detection. The purpose of FMEA is...

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Risk Management for Medical Devices

Jun 8, 2007 in Newsletter | 0 comments

The second edition of ISO 14971:2007, Application of Risk Management to Medical Devices, has been released. The revised version aligns better with ISO 13485:2003 requirements and provides an improved model for implementing a risk management system. ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The...

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