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sterigenics iso certificate

sterigenics iso certificate

2 min read 31-10-2024
sterigenics iso certificate

Sterigenics, a leading provider of medical device sterilization services, holds a wide range of ISO certifications, demonstrating its commitment to quality, safety, and environmental responsibility.

ISO 9001:2015 - Quality Management System

The ISO 9001:2015 certification ensures that Sterigenics operates a robust quality management system. This certification covers the following aspects:

  • Customer Focus: Sterigenics is dedicated to understanding and meeting customer needs and expectations.
  • Leadership: Strong leadership drives the organization's quality goals and objectives.
  • Engagement of People: All employees are empowered and encouraged to contribute to quality improvements.
  • Process Approach: Sterigenics utilizes a process-oriented approach to achieve consistent and predictable results.
  • Continual Improvement: The organization continually seeks to improve its processes and performance.

ISO 13485:2016 - Medical Device Quality Management System

The ISO 13485:2016 certification specifically addresses the unique requirements of the medical device industry. It ensures that Sterigenics adheres to the following principles:

  • Risk Management: Sterigenics identifies and manages risks related to its sterilization processes.
  • Product Traceability: Sterigenics maintains a robust system for tracking and tracing medical devices throughout the sterilization process.
  • Validation and Verification: Sterigenics rigorously validates its processes and verifies the effectiveness of sterilization.
  • Quality Records: The company meticulously documents all relevant information related to its sterilization services.

ISO 14001:2015 - Environmental Management System

Sterigenics is committed to environmental sustainability and holds ISO 14001:2015 certification. This certification demonstrates the company's commitment to:

  • Environmental Policy: Sterigenics has a clear and documented environmental policy.
  • Environmental Aspects: The company identifies and manages its environmental impacts.
  • Environmental Objectives and Targets: Sterigenics sets measurable objectives and targets for environmental improvement.
  • Continual Environmental Improvement: The organization continuously seeks to reduce its environmental footprint.

Benefits of Sterigenics ISO Certifications

The ISO certifications held by Sterigenics provide several benefits to customers:

  • Assurance of Quality: Customers can trust that Sterigenics provides high-quality and reliable sterilization services.
  • Enhanced Safety: The certifications ensure that Sterigenics meets the highest safety standards for medical device sterilization.
  • Regulatory Compliance: Sterigenics meets the requirements of various regulatory bodies worldwide.
  • Improved Efficiency: The certifications demonstrate Sterigenics' commitment to continuous improvement and efficiency.

In conclusion, Sterigenics ISO certifications are a testament to the company's dedication to quality, safety, and environmental responsibility. These certifications provide customers with assurance that they are receiving the highest quality sterilization services.

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