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ISO 13485

ISO 13485:2003 is an international standard pertaining to medical devices. This standard specifies requirements for a comprehensive management system for design, development, engineering and production of (parts of) medical equipment and devices. Pekago has been certificied according to ISO 13485:2003 since June 27, 2011. ISO 13485:2003 is a stand-alone international standard pertaining to medical devices that is harmonised with ISO 9001. This ISO standard, published in 2003, specifies requirements for a comprehensive management system for design, development, engineering and production of (parts of) medical equipment and devices.


Fundamental difference compared to ISO 9001:

  • focus on risk management activities and design transfer activities during product development
  • specific requirements for verification of the effectiveness of corrective and preventive actions
  • specific requirements for inspection and traceability for implants
  • specific requirements for documentation and validation of processes for sterile medical equipment/tools
  • promotion of awareness of laws and requirements pertaining to management responsibility
  • production control measures to ensure product safety

The standard requires documented procedures, declarations and record keeping.

Once achieved, this will serve as a new tool for the development of components for medical equipment in accordance with a uniform and controlled process.

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