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.

Who Should Apply for ISO 13485:2016?

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.

The Benefits of ISO 13485:2016

• Rapid and consistent cycle
• Reduced waste
• Process improvement as a system
• Increased customer satisfaction
• Greater credibility and prestige
• Increase the reliability and image of your company

How Can QACA Help You?

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.

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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.

Who should apply for ISO 22000: 2018 certification?

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.

Benefits OF ISO 22000:2018 Certification

• Processes' order and efficiency are being improved.
• Stability of the production process and high-quality services are guaranteed.
• Enhancement of a company's competitive advantage
• Increasing profits in businesses
• Improved economic growth by creating more high-quality jobs in the food business.
• Securing food insurance
• Minimal foodborne illness rates
• Documenting techniques, procedures, and methods.
• Increased confidence in public and state auditing agencies.
• Building mutual trust between a firm and a client over time.

How Can QACA Help You?

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

You can request an audit from us to evaluate your organization's performance based on ISO 22000:2018. 

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