Tornik LLC & EMS Mexico In Line To Receive ISO-13485 Certification


Oct 27 2014

Tornik LLC & EMS Mexico In Line To Receive ISO-13485 Certification

By: CMS Admin

Posted in: Contract Manufacturing


Tornik LLC, an international contract manufacturer of custom cables, harnesses, electromechanical assemblies and turnkey box builds, is currently in the process of completing its ISO 13485 certification.

ISO 13485 is a system standard specifically designed for companies helping to manufacture medical devices. This standard features many of the same requirements as ISO 9001: 2008. However, there are some additional requirements for process control, design control, retention of records, accountability, traceability, customer feed back and more.

Advantages of ISO 13485 Certification:

ISO 13485 certification is not mandatory in most markets. This is how we intend to benefit from ISO 13485:2003 certification:

  • Certification can lead to increased efficiency, better product quality and improved customer service within your company.
  • Ease of access to new markets: ISO 13485 certification is recognized by many governments, and may satisfy some or all of the quality system requirements in multiple countries. ISO 13485 is required by many companies in the medical device field.
  • We hope to demonstrate our long-standing commitment to quality and to expand our reach to additional companies in the medical device arena by achieving ISO 13485 certification.

ISO 13485 is the principle driving force behind the vision of a common set of global quality requirements for the medical device industry. The ISO 13485 guideline is the underpinning factor in the correlation between quality, overall business performance, and public health and safety in the industry.

Benefits For Our Customers

  • ISO 13485 compliant management systems adopt a risk management approach which includes assessment to identify & estimate risk, uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization.
  • Assures the customers that the product complies with all relevant product & service-oriented technical standards & regulations.
  • Emphasizes the cleanliness & sterility in the production area, which in turn increases efficiency & enhances safety at the workplace.

Tornik Cables

We at Tornik are proud of our company - its people, its manufacturing processes and its products. Our team strives to build quality into the manufacturing and business processes with the goal of achieving Six Sigma quality performance. Every product goes through 100% computerized testing and a complete inspections process. Through this emphasis on quality, Tornik develops and maintains long-standing relationships with its customers, helping them to succeed and achieve their objectives.

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