July, 2001 Newsletter Articles

Data, Information, Knowledge, and Wisdom

Jul 12, 2001 in Newsletter | 0 comments

The May 2001 Project Management Institute (PMI) newsletter offered these explanations on the differences between data, information, knowledge, and wisdom: Data: Factual material such as measurements and statistics, frequently quantifiable. Information: Data endowed with meaning and purpose, which may differ according to individual interpretation. Knowledge: Understanding of a science, art, or technique, which is gained from study, experience, or association. Wisdom: Use of knowledge, with ability to discern inner qualities and relationships...

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The Importance of Analyzing Correct Data

Jul 12, 2001 in Newsletter | 0 comments

Clause 8.4 of ISO 9001:2000 requires an organization to determine, collect, and analyze data to demonstrate the suitability and effectiveness of its quality management system, as well as, to evaluate where continual improvements can be made. Guidance in ISO 9004:2000 states that data should be analyzed to assess performance against plans and objectives. Analysis of data can help determine the cause of existing or potential problems and, therefore, guide decisions about corrective and preventive actions. To effectively evaluate the performance...

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ISO 13485 for Medical Devices to be Revised

Jul 12, 2001 in Newsletter | 0 comments

More than 70 delegates from 19 countries and international organizations gathered in Tokyo in April to attend the eighth meeting of ISO/TC 210, Quality management and corresponding general aspects for medical devices, which was hosted by the Japan Federation of Medical Devices Associations (JFMDA). The US delegation included 12 representatives of the Association for the Advancement of Medical Instrumentation (AAMI) member companies and the Food and Drug Administration (FDA). One of the most significant developments in Tokyo was agreement to...

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ISO/DIS 19011 Ready for Download as E-Standard

Jul 12, 2001 in Newsletter | 0 comments

The draft of the new ISO 19011 standard for auditing both ISO 9000 (quality) and ISO 14000 (environmental) management systems is now publicly available. Benefiting from the considerable body of experience from audits of ISO management systems, the standard will replace six existing ones in the ISO 9000 and ISO 14000 families. The new combined standard will help user organizations to optimize their management systems, ease the integration of quality and environmental management, and, in allowing single audits of both systems, should save money...

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Revised AS9100 to be Available in August

Jul 12, 2001 in Newsletter | 0 comments

The AS9100 quality standard for the aerospace industry has been revised for ISO 9001:2000 and will be available from the Society for Automotive Engineers (SAE) in early August. The revised AS9100 uses the ISO 9001:2000 clause structure and contains no new requirements (beyond those of ISO 9001:2000). However, AS9100 reinstates some language on inspection and test that was dropped from ISO 9001:1994. According to one of the document authors, this is a sensitive area for the Federal Aviation Administration and civil air authorities. Although...

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New Information About QS-9000 Certificates

Jul 12, 2001 in Newsletter | 0 comments

An earlier article said organizations would have to move from QS-9000 to ISO/TS 16949:2002 to continue their automotive scheme registrations. This information was based on ISO 9001:1994 being withdrawn in December, 2003 and there being no plans to revise QS-9000 for ISO 9001:2000. However, based on my conversation with Randy Dougherty, RAB Director of Registrar Programs, I have learned that a company registered to QS-9000:1998 could continue its registration indefinitely with a reference ISO 9001:1994 or ISO 9002:1994 on its certificate. The...

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