Working towards ISO 13485

With the increase in medical device plastic injection moulding, Tex Plastics are now working towards the medical device industry’s most widely used international standard for quality management.

11th October 2021

Guy Sentance Production Director & General Manager

Why Tex Plastics is working towards ISO 13485

By adopting this Quality Management System (QMS), will enable us to provide better management support and identify our customer requirements in relation to developing documentation including the Quality Policy, Quality Objectives, and Quality Manual, for the medical device moulding undertaken.

This will assist in creating the mandatory and additional processes and procedures necessary, for both organisations to properly create and deliver the new medical device product.

The benefits of working towards ISO 13485

Through implementing an ISO 13485 QMS Tex Plastics will facilitate better alignment of design and development requirements to many regulations, plus any requirements for traceability procedures. In addition to managing risk, clarification of management responsibilities and enhancement of product cleanliness requirements in the manufacturing process.

What is the difference between ISO 9001 and ISO 13485?

Even though ISO 13485:2016 is a stand-alone standard, it is based on ISO 9001:2008, as mentioned above. So, while ISO 9001 is an internationally recognised standard for any organisation in any industry, the ISO 13485 standard includes additional requirements that are specific for companies that manufacture ISO medical devices.

Some additional requirements of ISO 13485 for ISO medical devices include:

  • Documentation requirements for medical device files
  • Work environment requirements
  • Contamination control requirements
  • Production requirements for cleanliness of products
  • Production requirements for sterile medical devices
  • Requirements for reporting to regulatory authorities

This will enable Tex Plastics to consistently meet customer and applicable regulatory requirements when developing plastic injection moulding and assembly solutions for medical device manufacturers.

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