March, 2016 Newsletter Articles

ISO 13485:2016

Mar 1, 2016 in Newsletter | Comments Off on ISO 13485:2016

The third edition of ISO 13485 has been published as the replacement for ISO 13485:2003. ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, sets out the requirements for a quality management system specific to the medical devices industry. The new edition was issued to respond to the latest developments in quality management, technology, and regulatory requirements. With the standard applicable to so many types of products, the revision was no easy task. A medical device is any...

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ISO/TS 16949:2016

Mar 1, 2016 in Newsletter | Comments Off on ISO/TS 16949:2016

The International Automotive Task Force (IATF) has approved the first draft of the new ISO/TS 16949:2016 automotive quality standard to include additional stakeholder feedback. The revision work team is preparing for an April 2016 conference to obtain further stakeholder input. The IATF intends to release the transition strategy from ISO/TS 16949:2009 to ISO/TS 16949:2016 in April 2016. Pilot gap assessments will be conducted May through June 2016 worldwide. Feedback from these gap assessments will be used to further refine ISO/TS 16949:2016...

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ISO 45001 Review

Mar 1, 2016 in Newsletter | Comments Off on ISO 45001 Review

ISO 45001, the safety management system replacement for OHSAS 18001, has advanced to the Draft International Standard (DIS) stage, and is available for review at this web page. Your comments must be submitted by April 1, 2016. Every 15 seconds, a worker dies from a work-related accident or disease, and 153 people experience a work-related injury. These represent an enormous burden for organizations and society as a whole, costing over 2.3 million deaths a year, not to mention the more than 300 million non-fatal accidents. Now, with the draft...

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ISO 9001:2015 Classes

Mar 1, 2016 in Newsletter | Comments Off on ISO 9001:2015 Classes

We are offering public “ISO 9001:2015 Requirements and Transition Guidance” classes in Atlanta, GA and Orlando, FL. The course is also available as an on-site class, as is our “ISO 14001:2015 Requirements and Transition Guidance” course. ISO 9001:2015 Requirements and Transition Guidance Enrollment for our 2.0 day “ISO 9001:2015 Requirements and Transition Guidance” course is $795 and includes lunch both days. May 17-18, 2016 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention...

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New ISO 27000:2016

Mar 1, 2016 in Newsletter | Comments Off on New ISO 27000:2016

The recently revised ISO 27000:2016, Information technology – Security techniques – Information security management systems – Overview and vocabulary, gives a comprehensive view of information security management systems (ISMS) and defines related terms and definitions. All information held and processed by an organization is subject to the risks of attack, error, and natural disaster, and other vulnerabilities inherent to its use. Information security is therefore at the heart of an organization’s activities and...

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Gap Analysis Checklists

Mar 1, 2016 in Newsletter | Comments Off on Gap Analysis Checklists

Larry Whittington has developed ISO 9001:2015 and ISO 14001 checklists for the purpose of conducting a gap analysis of your current system against the new and changed requirement of the new standards. ISO 9001:2015 Gap Analysis Checklist The 27 page ISO 9001:2015 Gap Analysis Checklist contains 313 questions for organizations new to ISO 9001, and 119 delta questions for ISO 9001:2008 certified organizations. To read a description of the ISO 9001:2015 Gap Analysis Checklist, and see a sample page, go to this web page. You can buy the checklist...

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Workshop on Risk-Based Thinking

Mar 1, 2016 in Newsletter | Comments Off on Workshop on Risk-Based Thinking

ISO 9001:2015 replaces the requirement for preventive action with that of risk-based thinking (RBT). While the intent is to alleviate confusion, it may have actually created more due to the introduction of terminology not widely used elsewhere. Although it may mean greater variability in interpretation, it also allows more flexibility to adapt to the context of each organization. We now offer a 1.0-day on-site workshop to cover the specific risk-based thinking requirements, and to compare and contrast them with a formal risk management (RM)...

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