Compliancehelp Consulting, LLC

 Environmental management is now an indispensable part of every organization’s strategy because of adverse effects of business activities on nature and its resources. It puts emphasis on the implementation of the ISO 14001 environmental management standard , which promotes best measures and regulations for preventing environmental risks and reducing the impacts. An Environmental Management System (EMS) is a framework encompassing the practices for environmental management. It helps organizations to reduce the negative impacts and increase sustainability. The ISO 14001 standard provides them with key requirements for establishing the right EMS framework. In short, achieving the ISO 14001 standard verifies that your EMS is effective in controlling your environmental impacts and meets the organization’s goals regarding environmental sustainability.  However, to develop an appropriate and suitable EMS for your business, what you first need is to understand the fundamentals of EMS....

While quality assurance is a non-negotiable concept for medical device manufacturers, the ISO 13485 standard is the specific standard for medical device quality management systems.  The standard helps medical device organizations to manage the design, development, manufacturing, installation, repairing, maintenance, and sales of the medical devices. The standard specifies the requirements for establishing the QMS (Quality Management System) which encompasses the processes of medical device manufacturing and ensures that customer expectations and product regulations are met. Regulatory requirements for medical devices are also increasing often to enhance product safety because of growing public scrutiny. ISO 13485 also has gone through several changes throughout the years with the latest update completed in 2016.  If you have a medical device manufacturing organization, then you should learn about the necessary changes introduced in the latest version, which are intended to str...