August, 2003 Newsletter Articles

ISO Standard for Medical Laboratories

Aug 20, 2003 in Newsletter | 0 comments

ISO 15189:2003 has been published for medical laboratories to implement quality management systems based on ISO 9001:2000. “The new standard will help medical laboratories to organize their operation efficiently”, said John Zlockie, Secretary of the technical committee which developed the new standard. “It will help them to comply with regulatory requirements, to meet the expectations of their clients and, most importantly, to improve or maintain their service to patients.” ISO 15189:2003 (Medical Laboratories –...

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ISO 15288 – Next Standards Phenomenon?

Aug 20, 2003 in Newsletter | 0 comments

ISO 15288:2002 may be the next standards phenomenon. It’s timeliness and applicability to organizations in all sectors could give it a considerable impact on the world of business, similar to ISO 9000. Just as the ISO 9000 family of standards has distilled the essential characteristics of quality management into a set of generic requirements, ISO 15288 (Systems Engineering – System Life Cycle Processes) offers a portfolio of generic processes for the optimal management of all stages in the life of any product or service. Many...

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Toughest ISO 9001:2000 Requirements (8.5.1)

Aug 20, 2003 in Newsletter | 0 comments

In an earlier newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to interpret and implement. Clauses 4.1, 5.1, 5.4.1, 5.4.2, 6.2.2, 6.3, 7.3.1, 7.5.2, 8.2.1, and 8.4 have been addressed in past newsletters. This article picks up with clause 8.5.1, Continual Improvement. ISO 9001:2000, clause 8.5.1, states The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and...

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Challenges to U.S. Manufacturing

Aug 20, 2003 in Newsletter | 0 comments

According to a study released by the National Association of Manufacturers, “intense global competition and the rising cost of doing business in the U.S. threaten manufacturing’s capability to maintain the nation’s economic strength and standard of living.” The report cites the causes of the decline of U.S. manufacturing as: Increased competition Declining export opportunities Decreased R&D investments Lack of a skilled workforce See the report, “Securing America’s Future: The Case for a Strong...

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