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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
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.
The BRC Food, Packaging S&D, and A&B Certification is the global standard for food safety that specifies how processed foods and other goods should be created or prepared by retailer-branded foods, foodservice organizations, caterers, or manufacturers. By ensuring the consistency of quality, safety, and operational principles, BRC Global Standards provide confidence across the whole supply chain.
The BRC Food, Packaging S&D, and A&B Certification standard was developed for companies that purchase, import, or distribute products in the food and food packaging supply chain. This standard's methods ensure product safety, quality, and legality.
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for BRC Food, Packaging S&D, and A&B. Audits are conducted by our certified certification bodies that follow the BRC Global Standards.
You can request a certificate from us to evaluate your organization's performance based on BRC Food, Packaging S&D, and A&B Certification.
ISO 9001 is a global standard certification that guides the requirements for a quality management system (QMS). Organizations use ISO 9001:2015 standard to demonstrate their ability to consistently provide products and services that meet the needs of their customers and the requirements of the regulatory authorities. It is the most widely used standard in the ISO 9000 series and the only one to which organizations can certify.
The International Organization for Standardization (ISO), an international organization consisting of more than 160 national standards bodies first published the ISO 9001 in 1987. In September 2015, the most recent version of ISO 9001 was released.
ISO 9001:2015 is applicable to any organization, no matter its size or industry. More than one million organizations from over 160 countries have used the ISO 9001 standard requirements to improve their quality management systems.
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for ISO 9001:2015. Audits are conducted by our certified certification bodies that follow ISO 9001:2015. We help you create and implement a quality management system based on the most recent ISO 9001 standard principles.
IATF 16949:2016 is a global standard certification for Automotive Quality Management Systems. The International Automotive Task Force (IATF) members collaborated to develop IATF 16949, then submitted to the International Organization for Standardization (ISO) for approval and publication. The document is a common automotive quality system requirement based on ISO 9001 and customer-specific automotive sector requirements.
The IATF 16949 standard emphasizes the creation of a process-oriented quality management system that allows for continuous improvement, preventing defects, and reducing variation and waste in the supply chain. The goal is to efficiently and effectively meet the needs of the customers.
The IATF 16949:2016 applies to any organization that produces components, assemblies, or parts for the automotive industry. Anyone involved in the production of materials, assemblies or heat treatment, production or service parts, welding, painting, plating, or other finishing services.
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for IATF 16949. Audits are conducted by our certified certification bodies that follow the IATF 16949.
You can request an audit from us to evaluate your organization's performance based on IATF 16949.