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Introduction to ISO13485:2016 Management System

         ISO13485:2016 (Medical Devices-Quality Management System Requirements for Regulations) is a quality management system for the medical device industry. It is an organizational requirement for the need to prove its ability to provide medical devices and related services that continue to meet customer requirements and applicable regulatory requirements. The requirements of the quality management system have been met. It also provides a practical basis for manufacturers to meet medical device directives, regulations and commitments to product safety and quality. The ISO13485:2016 standard is an independent standard based on ISO9001:2008, which contains some special requirements for medical devices, and deletes certain requirements in ISO9001 that are not suitable for legal requirements. ISO13485:2016 includes a total of 8 chapters, the main content is 4-quality management system, 5-management responsibility, 6-resource management, 7-product realization and 8-measurement, analysis and improvement.

         Red Board (Jiangxi) Co., Ltd. formally obtained the ISO13485:2016 system certificate on May 12, 2021. It continues to meet customer requirements and applicable regulatory requirements, and continues to promote the effective use of the management system within the organization.


ISO 9001:2015 (Quality Management System)

        ISO 9001:2015 (Quality Management System) is the management system that directs and controls the organization in terms of quality. It puts forward specific requirements for the organization's quality management system. Through goal management, it advocates process methods that emphasize demand, value-added, process performance and effectiveness, and continuous improvement.Help organizations improve their internal management and overall performance, and verify their ability to provide products that meet customer requirements and applicable regulatory requirements, and continuously improve customer satisfaction.

        Red Board (Jiangxi) Ltd. formally obtained the certificate of ISO 9001:2015 system in 2009. After many years of system operation, the whole quality management body has been approaching perfection, performance indicators of various departments have been continuously improved, and the quality of the output products can ensure customer satisfaction.


IATF16949:2016 (Quality Management System for Automotive Manufacturing Parts and Related Service Parts Organization)

        IATF16949:2016 (Quality Management System for Automotive Manufacturing Parts and Related Service Parts Organization) is a quality management system for the automotive industry. In conjunction with the applicable automotive customer specific requirements and ISO 9001:2015 requirements, the basic quality management system requirements for automotive manufacturing parts and related service parts organizations are defined.On the basis of ISO 9001:2015, IATF16949:2016 adds more detailed requirements of the automotive industry in personnel capability, awareness and training, design and development, provision of production and service, control of monitoring and measuring devices, measurement, analysis and improvement, such as APQP, FMEA, PPAP, SPC, MSA, etc.

        Red Board (Jiangxi) Ltd. officially obtained IATF16949:2016 System Certificate in 2009. After years of continuous improvement, it has effectively guaranteed the quality of wiring boards for automobiles and improved customer satisfaction.


QC080000:2017(Hazardous Substance Process Management System)

        QC080000:2017 (Hazardous Substances Process Management System) is a management system that controls the processes of hazardous substances. It defines how organizations establish and implement critical processes (design and development, supply chain management, production process management, product inspection, etc.) to manage their hazardous substances.It is a supplement to ISO 9001:2015 (Quality Management System). It adds RoHS directive, halogen-free directive, REACH and other laws and regulations and customers'environmental requirements on the basis of ISO 9001:2015, which is consistent with ISO 9001:2015 framework.

        Red Board (Jiangxi) Ltd. formally obtained the QC080000:2017 System Certificate in June 2020. It will continue to meet the requirements of related parties and related laws and regulations, and continue to promote the application of management system in the organization.


ISO45001:2018(Occupational Health and Safety Management System)

        ISO45001:2018 (Occupational Health and Safety Management System) is a management system that controls the organization's hazard sources. It is the verification standard of the international safety and health management system and a new version of the original occupational health and safety management system (OHSAS18001).ISO45001:2018 provides an organization with a set of risk control management methods, identifies the sources of hazards existing in the products, services, activities and work environment of the enterprise through professional investigation and assessment and compliance appraisal of relevant regulatory requirements, formulates appropriate control plans for unacceptable sources of hazards and risks, implements control plans, and regularly inspects and evaluates occupational health and safety regulations.Establish and plan a management system that includes organizational structure, responsibilities, training, information communication, emergency preparedness and response.

        Red Board (Jiangxi) Ltd. formally obtained ISO45001:2018 System Certificate in June 2020. The company promises to continue to create a safe and healthy working and living environment for its employees, ensure the compliance of laws and regulations, continuously improve occupational health and safety performance, and assume the due social responsibility of a high-tech enterprise.


ISO/IEC 27001:2013(Information Security Management System)

        ISO/IEC 27001:2013 (Information Security Management System) is an effective management system to protect company information security.Ensuring the confidentiality, integrity and availability of company information and protecting the healthy, orderly and sustainable development of information technology process are widely adopted and recognized information security management standards worldwide.The goal of the ISO27001 information security management system is to ensure the security of all information systems and business in the enterprise, maintain the normal operation of the organization, and meet the product confidentiality requirements of customers through an integrated planning of information security solutions.

        Red Board (Jiangxi) Ltd. officially obtained ISO/IEC 27001:2013 System Certificate in June 2020, to continuously and effectively protect company information security and customer product information.


RBA (code of conduct for Responsible Business Alliance)

        The RBA (Responsible Business Alliance) Code of Conduct for Responsible Business Alliances, formerly known as EICC, is considered a code of conduct for human rights, environment and ethics in the global electronics supply chain involving labor and recruitment, health and safety, environmental responsibility, ethics and management systems.RBA certification aims to establish a standardized code of social responsibility behavior in the global supply chain of the electronics industry, to ensure occupational health and safety in the supply chain of the electronics industry, to respect and dignify workers, and to ensure that production processes are environmentally responsible.Highly echoes international human rights standards such as the United Nations Guiding Principles on Business and Human Rights, the Declaration on Fundamental Principles and Rights at Work of the International Labour Organization and the United Nations Universal Declaration of Human Rights.

        Red Board (Jiangxi) Ltd. has been certified by RBA for many years in succession, and obtained silver-grade certification in September 2020 (score: 200, total score: 200), which reflects the importance and commitment of Red Plate in social responsibility.The red board promises to meet RBA certification requirements as always, attach importance to social responsibility and continuously improve performance in social responsibility.


ISO 9001:2015 (Quality Management System)

         ISO 9001:2015 (Quality Management System) is the management system that directs and controls the organization in terms of quality. It puts forward specific requirements for the organization's quality management system. Through goal management, it advocates process methods that emphasize demand, value-added, process performance and effectiveness, and continuous improvement.Help organizations improve their internal management and overall performance, and verify their ability to provide products that meet customer requirements and applicable regulatory requirements, and continuously improve customer satisfaction.

         Red Board (Jiangxi) Ltd. formally obtained the certificate of ISO 9001:2015 system in 2009. After many years of system operation, the whole quality management body has been approaching perfection, performance indicators of various departments have been continuously improved, and the quality of the output products can ensure customer satisfaction.


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