July, 2014 Newsletter Articles

Free ISO/DIS 9001

Jul 1, 2014 in Newsletter | Comments Off on Free ISO/DIS 9001

The American Society for Quality (ASQ) is providing the Draft International Standard (DIS) version of ISO 9001:2015 free to anyone, with the condition that you review it and provide comments to prepare the U.S. position. Send an email to standards@asq.org to request a copy for review. Your comments must be submitted before July 15, 2014. According to ASQ, the timeline for ISO 9001:2015 is: Mid 2015: Expected publication of Final Draft International Standard (FDIS) End 2015: Publication of the International Standard as ISO 9001:2015 Please...

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ISO 13485 Revision

Jul 1, 2014 in Newsletter | Comments Off on ISO 13485 Revision

ISO/DIS 13485:201X, “Medical devices — Quality management systems — Requirements for regulatory purposes,” was published in February 2014.  The five month voting period for comments to be submitted by the National Standards Bodies to the ISO Central Secretariat will close in July 2014. The DIS comments will be reviewed at a September 2014 meeting of the ISO/TC 210 Working Group 1. The Final Draft International Standard (FDIS) version should be issued for a two month vote late in 4Q/2014. Assuming the FDIS is approved,...

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ISO 9001:2015, 9.1.1

Jul 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 9.1.1

This article provides a summary of the General requirements section of Monitoring, Measurement, Analysis, and Evaluation as stated in the Draft International Standard (DIS) version of ISO 9001:2015. The changes from the related ISO 9001:2008 requirements are also identified. ISO/DIS 9001:2015 Summary 9.1.1 General Determine: what needs to be monitored and measured the methods for monitoring, measurement, analysis, and evaluation, as applicable, to ensure valid results when the monitoring and measuring will be performed when the results from...

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ISO 9001:2015, 9.1.2

Jul 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 9.1.2

This article provides a summary of the Customer Satisfaction requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The DIS customer satisfaction differences from ISO 9001:2008 are also identified. ISO/DIS 9001:2015 Summary  9.1.2 Customer Satisfaction Monitor customer perceptions of degree to which requirements have been met Obtain information on customer views and opinions of the organization and its products and services Determine methods for obtaining and using this...

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ISO 9001:2015, 9.1.3

Jul 1, 2014 in Newsletter | Comments Off on ISO 9001:2015, 9.1.3

This article provides a summary of the Analysis and Evaluation requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The draft analysis and evaluation differences from ISO 9001:2008 are also identified. ISO/DIS 9001:2015 Summary  9.1.3 Analysis and Evaluation Analyze and evaluate appropriate data and information arising from monitoring, measurement, and other sources. Use the output of this analysis and evaluation to: demonstrate conformity of products and services to...

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EHSQ Manager Job

Jul 1, 2014 in Newsletter | Comments Off on EHSQ Manager Job

A client is looking for a Manager of EHSQ Management Systems, located in Atlanta, GA.  Please see the job description below, and if you are qualified and interested, contact David DiBoyan, Director of Americas EHSQ, at David.DiBoyan@Kemira.com. Position Summary: This position is responsible for managing the integrated safety, quality, and environmental management systems registered in Kemira’s Americas region.  This is a regional position interfacing with all functional departments, including sales, manufacturing, and logistics, with...

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