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ISO 13485:2016 is a global standard certificate that specifies requirements for a quality management system. Using the certificate, organization must demonstrate its ability to consistently provide medical devices and related services that meet customer and applicable regulatory requirements.
The ISO 13485 standard is an efficient way to meet all of the requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address regulations and responsibilities while also demonstrating a commitment to medical device safety and quality.
Organizations involved in one or more stages of the life-cycle of a medical device, such as design and development, production, storage and distribution, installation, or servicing, as well as design and development or provision of associated activities (e.g., technical support) can apply for the certificate.
ISO 13485:2016 can also be used by suppliers or external parties who provide products to such organizations, including quality management system-related services.
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for ISO 13485:2016. In addition, our certified certification body conducts audits that follow the ISO 13485:2016.
QACA helps achieve certification that can demonstrate to potential clients that they adhere to best practices and regulatory requirements. We help the company benefit from improved process control and continuous improvement, resulting in continuous ROI.
You can request a certificate from us to evaluate your organization's performance based on ISO 13485:2016.
Related Certificates
AS 9100 establishes the quality standards that must be met in all areas of aerospace, from commercial to defense aviation. The aviation industry is highly regulated, with requirements and controls in place to ensure the safety and dependability of equipment and materials. The industry places a high value on suppliers demonstrating effective management strategies.
AS9100 requirements helps in implementing an aerospace Quality Management System (QMS) in your organization can be one of the most important projects you undertake to improve the delivery of products and services; however, this activity is not without cost.
AS 9100 applies to any organization in the Aerospace Industry, from design and manufacture to maintenance and stock list distribution.
It is helpful for all companies in the aerospace industry looking to improve the performance of their quality management system. It includes all major manufacturers, designers, distributors, and service providers.
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for AS9100. In addition, our certified certification body conducts audits that follow the AS9100.
You can request a certificate from us to evaluate your organization's performance based on AS9100.
ISO 21001:2018 is an international standard developed by the International Organization for Standardization that provides management tools for educational products and service providers. Its goal is to assist education providers in meeting the requirements and needs of their students.
The ISO 21001:2018 certification ensures that the educational services provide effective and efficient services. The standards allow for a personalized experience for all learners, particularly those with special education needs and distance learners. Furthermore, by gaining ISO 21001:2018 certification, you can show stakeholders that you are dedicated to improving your educational system.
ISO 21001:2018 can be applied to educational organizations within larger organizations, such as professional training departments, whose core business is not education.
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for ISO 21001:2018. In addition, our certified certification body conducts audits that follow the ISO 21001:2018
You can request a certificate from us to evaluate your organization's performance based on ISO 21001:2018.
ISO 41001:2018 is a global standard certificate by the International Organization for Standardization that sets forth guidelines for facility management. It follows the same structure as other ISO standards, such as ISO 45001 (Occupational Health and Safety) and ISO 50001 (Energy Management), with the exact core text, definitions, and terms.
The standard aims to help organizations demonstrate efficient and effective FM, pursue consistency when defining FM requirements, and achieve sustainability. It standardizes FM concepts and requirements so that organizations of all kinds can benefit from it.
It is not sector-specific and intended to apply to all organizations or parts of organizations, public or private, regardless of the organization's type, size, nature, or geographical location.
ISO 41001's core objectives assist organizations in gaining the following advantages:
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for ISO 41001:2018. In addition, our certified certification body conducts audits that follow the ISO 41001:2018.
QACA helps your organization gain the confidence of stakeholders by recognizing various stages and offering comprehensive evaluations and reports.
You can request a certificate from us to evaluate your organization's performance based on ISO 41001:2018.
ISO 3834-2:2003 is a supplement to ISO 9001 requirements, bringing together a comprehensive solution of quality requirements related to welding as well as a Quality Management System. ISO 3834 specifies quality requirements for metallic materials fusion welding processes. It can be used in a variety of situations and applications, including railway vehicles, steel structures, pressure equipment, and so on.
All organizations concerned with fabrication industries, construction companies, i.e., on-site work, repair and maintenance contractors, and manufacturers of products, can apply for the certificate.
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for ISO 3834-2:2003. In addition, our certified certification body conducts audits that follow the ISO 3834-2:2003.
You can request a certificate from us to evaluate your organization's performance based on ISO 3834-2:2003.