ISO 13485 Medical Devices Injection Moulding

ISO 13485 Medical Devices Injection Moulding

Tex Plastics is thrilled to announce that we have achieved the prestigious ISO 13485 accreditation for our outstanding quality management system in the medical device manufacturing industry.


A customer driven accreditation starting back in October 2021

ISO 13485 is an international standard that specifies requirements for a quality management system for medical devices, it demonstrates our capability in producing safe and reliable medical devices, ensuring customer satisfaction, and complying with regulatory requirements in the healthcare sector.

The journey to achieving ISO 13485 involved all areas within the company to come together and develop new processes and procedures to achieve this accreditation. Although we have several other quality accreditations including ISO 9001 and ISO 14001, ISO 13485 is tailored specifically for the medical device industry. It addresses the specific regulatory and quality requirements unique to healthcare, while ISO 9001 and ISO 14001 have broader applicability across industries. Although we were experienced in cleanroom moulding and working to develop medical device prototypes, there were a number of other areas which needed more in-depth consideration.

“This achievement marks a significant milestone in our commitment to excellence and customer satisfaction. The expertise, diligence, and attention to detail of the wider team at Tex Plastics, has been instrumental in securing the ISO 13485 accreditation. We are committed to further investment in cutting-edge technologies, foster a culture of innovation, and collaborate closely with our partners to deliver the best possible solutions to the medical device industry.”

Dean Ward Project Manager, Tex Plastics


The 12 steps to achieving our ISO 13485 accreditation


1 - Certification Body Selection

To help us on our journey to achieving the medical devices standard, we selected an accredited certification body to advise and carry out the external audit of our organisation's quality management system.

2 Gap Analysis

We first had to conduct an initial assessment of our existing quality management systems and processes to identify any gaps between our current practices and the requirements of ISO 13485:2016+A11:2021. This step helped determine the work needed to achieve compliance.

3 – Planning

Following the gap analysis, we developed a project plan outlining the activities, timelines, and resources required to implement the necessary changes and meet the ISO 13485:2016+A11:2021 requirements. This plan also included selecting responsible individuals or teams for each task set-out.

4 - Training and Awareness

We had to ensure that all our staff, especially those involved in quality management, were aware of the new standard's requirements and trained on how to implement them effectively.

5 – Documentation

We developed and updated the required documentation, including quality manuals, procedures, work instructions, and records, to align with ISO 13485:2016+A11:2021.

6 – Implementation

Implementing the necessary changes and improvements was based on the gaps identified. This involved revising processes, updating documentation, establishing risk management procedures, and ensuring traceability of products.

7 - Internal Audits

We had to conduct internal audits to verify compliance with ISO 13485:2016+A11:2021 requirements and identify any non-conformances or areas for improvement.

8 - Corrective Actions

Non-conformances were identified and addressed during the internal audits by implementing appropriate corrective actions and preventive measures.

9 - Management Review

After, we conducted a management review to assess the effectiveness of the implemented changes, review the audit findings, and ensure ongoing compliance with the standard.

10 - External Audit

The certification body then performed an external audit to assess our compliance with the ISO 13485:2016+A11:2021 requirements. This involved a 2 stage audit process.

11 - Stage 1 Audit

For the first stage audit, the certification body evaluated our preparedness for the certification audit. They reviewed our documentation, implementation progress, and readiness for the final audit.

12 - Stage 2 Audit

At the second stage audit, the certification body performed an in-depth assessment of our quality management system to determine compliance with ISO 13485:2016+A11:2021. They examined processes, records, and interviewed staff to ensure that all the requirements were met.


The critical role our products play in improving patient outcomes and saving lives

Throughout the accreditation process, our team worked diligently to ensure that all necessary procedures and controls were in place to comply with the ISO 13485 standard. We implemented robust quality management systems, enhanced our risk management processes, and strengthened our overall operational efficiency.

We firmly believe that achieving ISO 13485 accreditation will open up new opportunities for collaboration with medical device manufacturers, healthcare organisations, and other stakeholders in the industry. It will serve as a testament to our commitment to producing high-quality, reliable, and safe medical devices that meet the stringent regulatory requirements.


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