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All You Need to Know About Final FDA Gluten-Free Labeling Rule of August 14, 2014

In today’s world consumer demand is a driving force that provides opportunity for organizations to meet the demand through a well-defined marketing strategy. Along with the demand, however, comes responsibility to provide what the customer wants in a safe and controlled manner. Consumers are increasingly seeking products that are Gluten-Free due to general health considerations … Read more All You Need to Know About Final FDA Gluten-Free Labeling Rule of August 14, 2014

How to Effectively Implement ISO 22301:2019 Business Continuity Management System Using ISO 22313:2020 for Achieving Disaster Recovery from Coronavirus (Covid-19) Pandemic

Current conditions were unexpected and probably the last thing that anyone thought would occur. Everything was going so well economically and business was picking up everywhere. Suddenly something totally off the radar happened and the world changed. Very few were prepared and found themselves asking “Which way do we turn? What do we do?” Hindsight … Read more How to Effectively Implement ISO 22301:2019 Business Continuity Management System Using ISO 22313:2020 for Achieving Disaster Recovery from Coronavirus (Covid-19) Pandemic

Application of Risk for Medical Devices (ISO 13485) and Medical Laboratories (ISO 15189) through ISO 14971 and ISO 22367

Under the present conditions with Covid-19, it is imperative to ensure the Application of Risk for Medical Devices ISO 13485:2016 and for Medical Laboratories Requirements for Quality and Safety ISO 15189. Both ISO 13485 and ISO 15189 standards are to comply with FDA requirements and the implementation medical devices and medical laboratories impact human injuries,  … Read more Application of Risk for Medical Devices (ISO 13485) and Medical Laboratories (ISO 15189) through ISO 14971 and ISO 22367

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 15378:2017 Primary packaging materials for Medicinal Products: New standard

The ISO 15378:2017 – Primary Packaging Materials for Medicinal products was developed by stakeholders in the pharmaceutical sector to provide a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products. Published first in 2006, the process-oriented ISO 15378 standard picks up this idea.Based on the internationally accepted … Read more ISO 15378:2017 Primary packaging materials for Medicinal Products: New standard

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

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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

Free List of Documented Processes Required for IATF 16949

Free List of Documented procedures required for ISO 13485

Free List of Documented Process Required for 15389

Comparison list for ISO 45001 VS OHSAS18001 VS ANZ4801