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03 October 2023

ISO 13485: Ensuring the Quality and Safety of Medical Equipment

Quality, Medical

The healthcare field requires an unwavering commitment to quality and safety, two fundamental pillars that must be guaranteed in each one of the products and services offered in injection for the medical sector.

In this context, the ISO 13485 standard, a globally recognized quality standard that guides organizations in the production and marketing of medical devices. 

Establishing systems based on this standard not only reinforces confidence and ensures compliance with the requirements, but also unfolds a series of operational and strategic benefits for the companies that implement it, such as us, manufacturers of plastic and liquid silicone LSR for multiple sectors such as medical, industrial, automotive, electrical, etc.

What is ISO 13485 and what is it for?

ISO 13485, issued by Applus+, is an internationally recognized standard for quality management systems applicable for medical devices. The standard is not product specific but is intended and conceived for use in organizations for the design and development, production, installation, service, and sales of medical devices.

ISO 13485 enables manufacturers of medical devices and related services such as OSF to increase their access to international markets, thereby demonstrating their compliance with regulatory requirements and customer expectations, in addition to the following advantages:

  • Improve internal processes.
  • Facilitating decision making.
  • Improve internal and external communication within the company.
  • Create a culture of continuous improvement.
  • Improve contracting capacity.

How to obtain ISO 13485 certification

At OSF, an improvement project was deployed during 2020 for the implementation of the ISO 13485 management system and the following steps were carried out:

  • Analysis of the standard and its requirements.
  • Assessment of the deficiencies of the currently implemented management system (IATF16949).
  • Development of an implementation plan.
  • Design of documentation.
  • Carrying out the necessary training for the team.
  • Conducting the internal audit and review.
  • Selection of the certification body.
  • Carrying out the third-party audit and certification process.
  • Obtaining the certificate.
  • Maintaining the certificate. Renewal every 3 years and annual follow-up audits.

In addition to the advantages already mentioned, which are produced for the company itself and for its clients by the implementation and maintenance of an ISO13485 certification, it is important to highlight those that it generates for the medical sector:

  • Confidence in the organizations that market healthcare products and/or services. Lsr liquid silicone manufacturing.
  • Greater safety for the end user.
  • Greater competitiveness in the sector, which promotes a higher quality of the products marketed. 

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