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Additional Requirements for Manufacture of Medical Devices to be exported to EU. Changes in ISO 13485:2016

Manufacture of Medical Devices

European union has changed its regulations with respect to Active Implantable Medical Devices. Medical device manufacturers were following the directive under (MDD) 93/42/EEC to comply with for their implantable devices and for of Active Implantable Medical Devices must follow the Directive detailed in 90/385/EEC (referred to as ‘MDD/AIMDD’) On 26th May 2017 European Union issued … Read more Additional Requirements for Manufacture of Medical Devices to be exported to EU. Changes in ISO 13485:2016

Hazard Prevention is of Prime Importance in Food Safety

Hazard Prevention is of Prime Importance in Food Safety

“WASHINGTON, June 20, 2019 – C&S Wholesale Grocers, located in Westfield, Mass. is recalling an undetermined amount of ready-to-eat and not-ready-to-eat meat and poultry products due to temperature abuse during transport, which may have resulted in the growth of spoilage organisms or pathogens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced … Read more Hazard Prevention is of Prime Importance in Food Safety

Information Security Management System ISO 27001:2013

The news that Cambridge Analytica Ltd. used personal information of more than 3 million American citizens had many eyebrows raised. Although Cambridge Analytica gained national attention, there have been others who have used tools to gather personal information for marketing or other purposes. Companies who legitimately take far reaching efforts to safe guard customer’s information … Read more Information Security Management System ISO 27001:2013

ISO 45001 Implementation and Benefits

ISO 45001:2018- Required Occupational Health & Safety Training​

ISO Publishes OH&S Standard ISO 45001: International Organization for Standardization (ISO) have kept their word once again and as committed have published a comprehensive International Standard ISO 45001 in March 2018 which is a standard aimed at creating a complete Organization’s Occupational Health and Safety Management System (OH&S Management) If one were to look at … Read more ISO 45001 Implementation and Benefits

AS 9100D Transition and Implementation

Running out of time for Transitioning to AS 9100D: Aerospace Standards have been revised in 2015 to AS 9100 D. Reason for the revision is periodic revision to be in line with developments in the Industry and to align with latest International Quality Standards such as ISO 9001;2015 and others. All organizations engaged in providing … Read more AS 9100D Transition and Implementation

ISO 50001-Energy Management Systems –ISO initiative

Energy is one of the important requirements of our life. It is difficult to imagine life without energy. Energy for use by humans and equipment is produced both by renewable energy sources and non-renewable energy sources.  As per an article in IFL  Science, the amount of energy produced from renewable sources is only 22 % and … Read more ISO 50001-Energy Management Systems –ISO initiative

Eight Pillars of Total Productive Maintenance: A Point to Ponder

total productive maintenance

Most management gurus advocate that the operational process management is through management of “5Ms”. The 5 M stand for Man, Money, Materials, Methods and Machine. Total Productive Maintenance is yet another tool for maximizing productivity and minimize losses in any industry by improving efficiency of the machine. If all eight pillars of TPM are judiciously … Read more Eight Pillars of Total Productive Maintenance: A Point to Ponder

Importance and Implementation of ISO 55001

Atlanta – The world’s busiest airport experienced an unprecedented power outage that seemed to defy all of the precautions put in place to prevent it, and during the 11-hour ordeal, internet users noted that only one mysterious plane was allowed to leave the airport. Over 1,000 flights were canceled when the Hartsfield-Jackson Atlanta International Airport … Read more Importance and Implementation of ISO 55001

Medical Device Single Audit Program (MDSAP)

Way Back in 2012 the International Medical Device Regulatory Forum (IMDRF) Work Group developed a standard called Medical Device Single Audit Program. These are a set of requirements for auditing organizations performing regulatory audits of medical device manufacturers’ and their quality management systems.   The program’s main mission is to “…jointly leverage regulatory resources to … Read more Medical Device Single Audit Program (MDSAP)

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One filled in Risk Register for the Packaging Industry

Att. 6.1.1.01 Risk Register to record all Processes with color codes

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