April, 2012 Newsletter Articles

FDA and ISO 13485

Apr 1, 2012 in Newsletter | 0 comments

The Food and Drug Administration (FDA) has issued the Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program and it is expected to go live in June 2012. The ten page guidance document shares the FDA framework for manufacturers, in good compliance with QMS / QSR requirements, to voluntarily submit ISO 13485 reports and certifications to the FDA. This will allow the FDA to remove the manufacturer from the FDA inspection schedule for 12 months. This guidance provides information on the implementation of section 228 of the...

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ISO 20000 Guidance

Apr 1, 2012 in Newsletter | 0 comments

The ISO 20000-2:2005 Code of Practice has been replaced by ISO 20000-2:2012, Information Technology – Service Management – Part 2: Guidance on the Application of Service Management Systems. ISO 20000-2:2012 provides guidance on the application of service management systems based on the requirements in ISO 20000-1:2011. It enables organizations and individuals to interpret ISO 20000-1 more accurately and, therefore, to use it more effectively. The guidance includes examples and suggestions to enable organizations to interpret and...

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Performance Metrics

Apr 1, 2012 in Newsletter | 0 comments

This article was written by Duke Okes, one of our Associates. He is the author of a popular book on Root Cause Analysis and teaches our Root Cause Analysis course. He has developed a new course on Measuring Process and Organizational Performance (see the course description at the end of this article). Although metrics are a necessary component for managing organizational performance, they often elicit behaviors at odds with actual needs. In order to optimize the use of metrics, an organization should use a structured process to select them,...

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Ten Commandments

Apr 1, 2012 in Newsletter | 0 comments

These Ten Commandments for top management are based on ISO 9001, clause 5, Management Responsibility, and were presented by Rick Giguere at a conference in Tampa this year for National Quality Assurance (NQA) auditors. I. Thou shalt be committed to your quality management system and continually strive to improve its effectiveness, (5.1). II. Thou shalt aim to enhance customer satisfaction, (5.2). III. Thou shalt believe in your quality policy and foster an environment for others to believe, (5.3). IV. Thou shalt live your quality policy by...

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ISO: Farm to Fork

Apr 1, 2012 in Newsletter | 0 comments

ISO’s solutions for ensuring quality and safety in the food industry are the subject of a new brochure, “ISO & food”, which provides a concise overview of the International Standards available and how they can help. Today more than ever, food products regularly cross national boundaries at every stage of the supply chain. ISO standards create confidence in the products we eat or drink by ensuring the world uses the same recipe when it comes to food quality, safety, and efficiency. The new 4 page brochure explains the...

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