November, 2018 Newsletter Articles

ISO 9001:2015 Classes in Orlando, Florida

Nov 1, 2018 in Newsletter | Comments Off on ISO 9001:2015 Classes in Orlando, Florida

Larry Whittington will be the instructor for these ISO 9001:2015 classes in Orlando, Florida: ISO 9001:2015 Requirements   December 17-18, 2018 January 28-29, 2019 June 24-25, 2019 ISO 9001:2015 Internal Auditor December 17-19, 2018 January 28-30, 2019 June 24-26, 2019 ISO 9001:2015 Lead Auditor December 17-20, 2018 January 28-31, 2019 June 24-27 2019 Click on a course title to view the course description and enroll in a class. If you have questions about the training or registration process, please call...

Read More

Energy Management Systems

Nov 1, 2018 in Newsletter | Comments Off on Energy Management Systems

Using energy efficiently helps organizations save money, conserve resources, and tackle climate change. ISO 50001 supports organizations to use energy more efficiently through the development of an Energy Management System (EnMS). The new ISO 50001:2018 edition, Energy management systems – Requirements with guidance for use, provides a framework of requirements to: develop a policy for more efficient use of energy; fix targets and objectives to meet the policy; use data to better understand and make decisions about energy...

Read More

FDA and ISO 13485

Nov 1, 2018 in Newsletter | Comments Off on FDA and ISO 13485

According to the U. S. Food and Drug Administration (FDA), it intends to harmonize and modernize the Quality System regulation for medical devices. The FDA announcement states that the revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. ISO 13485 ISO 13485:2016, “Medical devices...

Read More

ISO Guide 41 on Consumer Packaging

Nov 1, 2018 in Newsletter | Comments Off on ISO Guide 41 on Consumer Packaging

A recent ISO article described packaging as having come a very long way since its humble beginnings of gourds and clay pots. These days, the world of packaging is much more complex, needing to be safe and sustainable, while remaining appealing and functional. The article related that the humble glass bottle, which is making a comeback thanks to its facility for recycling, was first commercialized by the ancient Egyptians some 3,500 years ago. About 1,300 years later, the Chinese gave us paper, but it wasn’t until the 19th century that...

Read More

Integrated Management Review

Nov 1, 2018 in Newsletter | Comments Off on Integrated Management Review

Top management reviews of a management system are critical to evaluate performance and determine trends for decisions and actions. The quality standard (ISO 9001:2015), environmental standard (ISO 14001:2015), and health and safety standard (ISO 45001:2018) all include requirements for management review. This article describes a management review process for an integrated quality, environmental, and health and safety management system. Requirements for Review Top management must review the organization’s management system, at planned...

Read More