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ISO 13485 | Medical Devices

ISO 13485 is a global standard certificate that specifies requirements for a quality management system. Using the certificate, the 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?

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 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

  • • 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. In addition, our certified certification body conducts audits that follow the ISO 13485. 

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.

Related Certificates

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The ISO 20000-1 standard establishes a set of requirements for organizations to establish, implement, maintain, and continuously improve a service management system (SMS).

Organizations can use the guidance in this standard as a framework for managing SMS effectively. ISO 20000-1 (Service Management System Requirements) and ISO 20000-10 (Concepts and Vocabulary) were updated in September 2018 to address evolving needs and challenges in IT service management delivery.

 

Who Should Apply for ISO/IEC 20000-1 (IT)? 

All service providers, large or small, in IT services, facilities management, and business services wanting to ensure their services' quality should get ISO/IEC 2000-1. The ISO 20000-1 helps ensure services that adapt to the changing service delivery system. 

 

The Benefits of ISO 20000-1

  • • Get Globally recognized Certification 
  • • Enhanced customer satisfaction
  • • Quality service delivery 
  • • Better Understanding of business responsibilities and goals
  • • Ability to manage and protect the organization, assets, stakeholders, and management 
  • • Reduced number of incidents
  • • Risk incident management 
  • • Improving organization reliability 
  • • Quick response times with minimal disruptions to IT service

 

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 20000-1. In addition, our certified certification body conducts audits that follow the ISO 20000-1.

You can request a certificate from us to evaluate your organization's performance based on ISO 20000-1.

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The International Railway Industry Standard (IRIS) is a globally recognized method for assessing business management systems throughout the railway supply chain. It is based on ISO 9001 and is customized to the specific needs of the global railway industry.

Who Should Apply for IRIS? 

IRIS is a certification programme for manufacturers of parts, components, and rail-mounted vehicles, as well as operators.

The Benefits of IRIS(Railways)

  • • Instil confidence in your products and services by demonstrating that they meet the rail industry's expectations and standards.
  • • In addition to increased efficiency and effectiveness, IRIS allows you to supply all significant rail manufacturers.
  • • IRIS shares elements with ISO 9001:2015, making it simple to integrate with the standards you already use.
  • • IRIS certification and ISO/TS 22163 are globally recognized and provide access to best practices from the rail industry.
     

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 IRIS(Railways). In addition, our certified certification body conducts audits that follow the IRIS(Railways). 

You can request a certificate from us to evaluate your organization's performance based on IRIS(Railways).

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ISO 9001 is a global standard certification that guides the requirements for a quality management system (QMS). Organizations use ISO 9001 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.

Who Should Apply for ISO 9001 Certifications?

ISO 9001 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.

The Benefits of ISO 9001 Certification

  • • Increase in profitability and market share
  • • Saving time because of better resource management
  • • Process integration and process automation reduce the need for manual labour.
  • • Using data and evidence to inform decision-making improves organizational efficiency and effectiveness.
  • • Minimal or elimination of recurring issues and anomalies
  • • Improving the brand image and credibility of the organization

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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 9001. Audits are conducted by our certified certification bodies that follow ISO 9001. We help you create and implement a quality management system based on the most recent ISO 9001 standard principles.

You can request an audit from us to evaluate the performance of your QMS against the most recent ISO 9001 standard.

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ISO 3834 certification is a globally recognized documented evidence of the manufacturer's ability to produce minimum specified quality products. It means that the most stringent welding management system requirements were adhered to while producing the products. This globally recognized standard (ISO 3834) specifies the quality requirements for fusion welding of steel materials in the welding workshop and on the fabrication site.

 

Who Should Apply for ISO 3834?

The ISO 3834 standard applies to anyone who fabricates structural metalwork or uses quality control of welding processes.

The Benefits of ISO ISO 3834

  • • Process and procedure enhancements
  • • Reduction in costs and overheads 
  • • Built-in weld quality assurance
  • • Minimization of risk
  • • Credibility and capability recognized on a global scale
  • • Demonstrate the high quality of your products
  • • Strengthening your competitive position

 

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 3834. In addition, our certified certification body conducts audits that follow the ISO 3834.

You can request a certificate from us to evaluate your organization's performance based on ISO 3834.