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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
Food Safety System Certification 22000 (FSSC 22000) is an internationally recognized, ISO-based certification process for food safety auditing and certification in the food and beverage manufacturing industry.
FSSC 22000 is based on the ISO 22000, ISO 22003, and technical specifications for sector prerequisite programs (PRPs), created after long, extensive and open consultation with a wide range of stakeholders.
Anyone who desire to upgrade their certification to a GFSI recognized Standard, FSSC 22000 is the next logical step.
FSSC 22000 can be used by organizations in the food/feed supply chain of any size or complexity. Makers of various types of food and beverages, ingredients/additives, pet and animal feed manufacturers, and packaging manufacturers are all included.
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for FSSC 22000 Certification. Our certified certification body conduct an audit that follows the FSSC 22000 Certification.
You can request a certificate from us to evaluate your organization's performance based on FSSC 22000 Certification.
A business continuity management system (BCMS) is a comprehensive approach to organizational resilience that assists organizations in dealing with incidents that affect their business-critical processes and activities.
The best-practice business continuity management system requirements are outlined in ISO 22301:2018. (BCMS). Certification to the Standard confers a slew of advantages.
It provides a framework for organizations to update, control, and deploy effective plans while accounting for organizational contingencies and capabilities, and business needs.
This document applies to all types and sizes of organizations-regardless of any geographic location.
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for ISO 22301:2018. In addition, our certified certification body conducts audits that follow the ISO 22301:2018.
You can request a certificate from us to evaluate your organization's performance based on ISO 22301:2018.
ISO 14001:2015 is a globally recognized standard that lays out the standards for a quality environmental management system. It assists firms in improving their environmental performance through more effective resource utilization and waste reduction, resulting in a competitive advantage and stakeholder confidence.
Any organization that wishes to build, upgrade, or maintain an environmental management system in accordance with its specified environmental policy and standards should adopt ISO 14001:2015.
The ISO 14001:2015 standards can be incorporated into any environmental management system to varying degrees. It depends on the organization's business, environmental policy, product and service offers, and geographic location.
A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for ISO 14001:2015 standards. Audits are conducted by our certified certification bodies that follow ISO 14001.
We help you identify the legal requirements for the EMS by defining your environmental policy, environmental aspects, and environmental objectives and targets. In addition, we help you meet the overall scope and implementation of the environmental management system. We ensure that you develop the necessary and optional processes and procedures for your organization's operations.
You can request an audit from us to evaluate your organization's performance based on ISO 14001:2015.