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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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Implementing and applying an occupational health and safety management system is a significant help in controlling and steering work protection, health, and safety risks. For example, using an occupational health and safety management system makes it possible to reduce absences resulting from sickness and accidents at work. Moreover, the management system is linked to a considerable improvement in legal certainty.

ISO 45001 is an international occupational health and safety standard that was developed to safeguard employees and visitors from work-related injuries and diseases. In addition, ISO 45001 certification was created to mitigate any circumstances that could cause irreparable harm to employees and enterprises.

 

Who Should Apply for ISO 45001 (OHS) Certification?

ISO 45001 is a global standard for occupational health and safety management systems that checks for procedures, guidelines and SOPs, to enhance employee and other personnel safety and health. This ISO 45001 standard is intended to apply to any business or industry-no, matter what the size.

 

The Benefits of ISO 45001 (OHS)

  • • Improving the accuracy of identifying danger and risk assessment
  • • Reduces downtime
  • • Reduce overall expenses of workplace events, and the number of claims for insurance premiums
  • • Obtain the internationally recognized QACA certificate.
  • • Enhances organization productivity through leadership involvement as well as worker participation.

 

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 45001 (OHS). In addition, our certified certification body conducts audits that follow the ISO 45001 (OHS).

Other advantages include helping you with: 

  • • Worker Safety
  • • Risk Management
  • • Risk Reduction
  • • Injury Prevention
  • • Enhanced Occupational Health Measures
  • • Statutory Identification and Compliance Evaluation
  • • Improve Productivity
  • • Enhance Organizational Safety Culture

You can request a certificate from us to evaluate your organization's performance based on ISO 45001. 

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ISO 41001 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.

 

Who Should Apply for ISO 41001?

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.

 

The Benefits of ISO 41001

ISO 41001's core objectives assist organizations in gaining the following advantages:

  • • Improving worker safety, health, and well-being of workers
  • • Enhancing productivity
  • • Increasing effectiveness and efficiency
  • • Improving communication, especially regarding FM requirements and methodologies
  • • Improving service consistency
  • • FM standardization across all organizational types
  • • Credibility recognized on a national and international scale

 

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 41001. In addition, our certified certification body conducts audits that follow the ISO 41001.

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.

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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. 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.

 

Who Should Apply for ISO 22301?

This document applies to all types and sizes of organizations-regardless of any geographic location. 

 

The Benefits of ISO 22301

  • • Safeguarding organization assets, turnover, and profits.
  • • Creating a strong response and recovery system.
  • • Helping in complying with all legal and regulatory requirements
  • • Monitoring and testing the company’s BCP to ensure its effectiveness.
  • • Improving the organization's competitive advantage
  • • Enhancing processes and organizational structures
  • • Reducing the cost of downtime in your business.
  • • Implementing comprehensive and customized standards

 

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 22301. In addition, our certified certification body conducts audits that follow the ISO 22301. 

Other advantages include of QACA include helping organizations in: 

  • • Operational resilience
  • • Emergency preparedness
  • • Corporate governance
  • • Crisis management
  • • Disaster recovery
  • • Supply chain security
  • • Protection of reputation in a crisis
  • • Preparation for technology failures
  • • Plan for a sudden loss of critical resources
  • • Preparation for other emergencies

You can request a certificate from us to evaluate your organization's performance based on ISO 22301.