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Why the Medical Industry Relies On ISO Standards

In the world of precision machining, one of the top industries we create feature-rich parts for is the medical industry. To ensure high-quality, uniform components, there are various certifications that must be obtained, which include specific certifications through the International Organization for Standardization (ISO). 

While there are some ISO certifications that pertain to machining and manufacturing in general, there are also specific standards that are for the medical industry. These certifications, such as the ISO 13485:2016, apply to any and all medical parts that Swiss Precision Machining (SPM) produces. Find out more about ISO certifications and why they’re so important in the medical industry.

What is the ISO?

Based in Switzerland, the International Organization for Standardization is an independent, non-governmental international organization that 165 different countries pertain to. There are different categories of standards, including:

  • Quality management
  • Environmental management
  • Health and safety
  • Energy management
  • Food safety
  • IT security

While there are more than 21,584 standards currently in place, some of the most common pertain to things that form part of most people’s normal day-to-day life. ISO 9000 certifications pertain to quality management in workplaces of all sizes, while ISO 45000 certifications deal with workplace risks and worker safety. There is even a standard for date and time format, ISO 8601.

ISO standards and the medical industry

Over 1,000 standards alone apply to healthcare, wellbeing, and safety—and that’s not even taking into account the standards that apply to medical machines, parts, devices, and more. A simple search on the ISO website for the term “medical” reveals 890 results under “Standards,” including, but not limited to, certifications and requirements for different types of medical devices, equipment, laboratories, and protective apparel.

One of the most important ISO standards to SPM is ISO 13485, which focuses on medical devices. “Safety and quality are non-negotiable in the medical devices industry,” as the ISO website states. “Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery.”

ISO 13485 is intended for “organizations involved in the design, production, installation and servicing of medical devices and related services.” Getting even more specific, ISO 13485:2016 refers to quality management systems and, within that, requirements that must be met for regulatory purposes. Applicable to companies of all sizes, these requirements pertain to monitoring, maintaining, and controlling the organization’s processes for quality and quality control.

Other ISO certifications

SPM also maintains the aforementioned ISO 9001 certification, which is the general standard for quality management, which is not specific to any one industry. In order to obtain this certification, SPM had to exhibit the highest level of quality control, provide a machining portfolio of projects that went above and beyond, and show clear strategies for how we plan to continuously improve our processes.

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