June, 2019 Newsletter Articles

ISO 14001 Family of Standards

Jun 1, 2019 in Newsletter | Comments Off on ISO 14001 Family of Standards

The core standard for the ISO 14001 family of standards is ISO 14001:2015, Environmental management systems – Requirements with guidance for use. To support users of ISO 14001, TC207/SC1 has established four categories of related standards: Overall Understanding and Implementation ISO 14004:2016, EMS – General guidelines for implementation ISO 14005:2019, EMS – Guidelines for a flexible approach to phased implementation Evaluating Strategic and Financial Consequences ISO 14007 (due 2019), Environmental management:...

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ISO 14005:2019

Jun 1, 2019 in Newsletter | Comments Off on ISO 14005:2019

The second edition of ISO 14005, “Environmental management systems – Guidelines for a flexible approach to phased implementation” has been released. The document gives guidelines for a phased approach to establish, implement, maintain, and improve an environmental management system (EMS) that organizations, including small and medium-sized enterprises, can adopt to enhance their environmental performance. The phased approach provides flexibility for organizations to develop their EMS at their own pace, over a number of phases,...

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RCA/CAPA for the Medical Device Industry

Jun 1, 2019 in Newsletter | Comments Off on RCA/CAPA for the Medical Device Industry

We have a new course: Root Cause Analysis and Corrective Action/Preventive Action for the Medical Device Industry. It is available to be taught onsite by the course developer, Duke Okes. COURSE SUMMARY A 2-day course consisting of lectures, practices, and role plays that will provide attendees with an in-depth understanding of how to analyze a system in order to identify the root causes of problems. The following topics are covered: The requirements of ISO 13485 and 21-CFR-820 for corrective and preventive action The difference and links...

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