ISO

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The most popular ISO certificates : ISO 9001 (quality management), ISO 14001 (environmental management), ISO 45001 (occupational health and safety), ISO/IEC 27001 (information security), ISO 22000 (food safety), and ISO 13485 (medical device quality management) 

ISO 9001 (quality management) : ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.

ISO 14001 (environmental management) : ISO 14001 is the international standard that specifies requirements for an effective environmental management system (EMS). It provides a framework that an organization can follow, rather than establishing environmental performance requirements.

ISO 45001 (occupational health and safety) : ISO 45001 is the world’s international standard for occupational health and safety, issued to protect employees and visitors from work-related accidents and diseases. ISO 45001 certification was developed to mitigate any factors that can cause employees and businesses irreparable harm. Its standards are the result of great effort by a committee of health and safety management experts who looked closely at a number of other approaches to system management — including ISO 9001 and ISO 14001.  

ISO/IEC 27001 (information security) : ISO 27001:2013 is the international standard that provides a framework for Information Security Management Systems (ISMS) to provide continued confidentiality, integrity and availability of information as well as legal compliance. ISO 27001 certification is essential for protecting your most vital assets like employee and client information, brand image and other private information. The ISO standard includes a process-based approach to initiating, implementing, operating and maintaining your ISMS.

ISO 22000 (food safety) :  ISO 22000:2018 is the newly revised International Food Safety standard, designed to harmonize on a global scale the requirements for food safety management for businesses within the food chain.

ISO 22000 combines and supplements the core elements of ISO 9001 and HACCP to provide an effective framework for the development, implementation, monitorization and continual improvement of a documented Food Safety Management System (FSMS) within the context of the organization’s overall business risks.

ISO 13485 (medical device quality management) : “ISO 13485 Certified” means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices. 

What is the purpose of ISO 13485?

ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS in the medical device industry. Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.