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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 22000:2018 is a certification for food safety management systems. Any organization in the food supply chain must comply with the food safety management system's requirements. It specifies what an organization must undertake to demonstrate its capacity to manage food safety risks and ensure that food is safe to eat.
ISO 22000:2018 certification can be used by any company within the food chain, regardless of its size. The certification is given to primary producers, feed producers, food manufacturers, transport and storage operators, and retail and food outlets subcontractors.
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for ISO 22000:2018 Certification. Our certified certification bodies conduct audits that follow the ISO 22000:2018 Certification.
Other advantages include:
• Ensuring that all statutory and regulatory food safety requirements are met.
• Accepting customer food safety requirements and demonstrating compliance
• Effectively communicating food safety issues to interested parties within the food chain
• Ensuring that the organization adheres to its stated food safety policy
• Demonstrating compliance to relevant interested parties
ISO/IEC 27001:2013 is the global standard certificate for information security. It lays out the requirements for a data security management system (ISMS). The best-practice approach outlined in ISO 27001 assists organizations in managing information security by addressing people, processes, and technology. The ISO 27001 standard is a globally recognized indicator that your ISMS is compliant with information security best practices.
The ISO framework is a set of policies and procedures that businesses can use to gain the trust of their clients and raise company productivity. ISO 27001 provides a framework for enterprises of any size or industry to use an Information Security Management System to protect their information methodically and cost-effectively (ISMS).
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for ISO/IEC 27001:2013 (IT). Audits are conducted by our certified certification bodies that follow the ISO/IEC 27001:2013 (IT).
You can request a certificate from us to evaluate your organization's performance based on ISO/IEC 27001:2013 (IT) Certification.
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.
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