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ISO 13485 Medical Devices Quality ManagementISO 13485 Medical Devices Quality Management

Quality is an important aspect of the Medical Devices industry. You may find that customers are often asking for proof of quality assurance from your organization. The medical device manufacturing sector has become more regulated everyday in which significant quality systems and product requirements must be satisfied.

The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose. This means that it will get harder for you to manage the quality of your medical devices operation as you are forced to comply with more regulations everyday. Though you may practice standard quality management within your organization, ISO 13485 is specific to the medical devices and thus will likely apply to you if you are within the industry.


Why you need to implement and certify ISO 13485?

  • Minimize potential quality issues with 3rd party audit with regular audit on your system to ensure that you are constantly in compliance with regulatory laws to minimize quality issues.
  • Increase public image and accountability by showing your commitment to quality assurance to your stakeholders and most importantly your potential customers.
  • Increase responsiveness to issues and non-conformities
  • Compliance to local and international regulations for exporting and trading of medical devices
  • A standard pre-requirement for medical devices manufacturers and designers


Using the BSI Assurance Mark

ISO 13485 Medical Devices Quality ManagementUse the BSI Assurance Mark and demonstrate excellence to your stakeholders. Upon receiving your certificate, you will also be given a general guide and a BSI Assurance Mark for you to use, creatively. There are many ways to use this mark. You can choose to put it in:

  • Corporate stationery
  • Business card
  • Marketing collateral, brochures and pull up banners
  • Corporate vehicle
  • Corporate website, micro-site and promotional sites
  • Building signage and building vinyl decal

If you are not sure how you can maximize the usage of your Assurance Mark, speak to us and we will help you figure it out.

> Check out other post certification services that BSI offer


What do you want to do now?

It doesn't matter if you're looking for certification, training or even just exploring your options. We are ready to listen and guide you through.

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Quality is an important aspect of the Medical Devices industry. You may find that customers are often asking for proof of quality assurance from your organisation. Though you may practice quality management within your organisation, publically demonstrating that you follow an international standard of medical devices quality benchmark is another aspect.

The medical device manufacturing sector has become more regulated everyday in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose.

This means that it will get harder for you to manage the quality of your medical devices operation as you are forced to comply with more regulations everyday.

When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products. Ensuring effectiveness, control, and maintenance of your quality management system is critical to customers, stakeholders, and regulatory agencies.

ISO 13485 Medical Devices is a stand-alone quality management system Standard, and its purpose is to help you build a practical foundation to address the regulations, your responsibilities and your commitment to demonstrate the safety and quality of your medical devices.

The value of ISO 13485 Medical Devices is not just in the implementation, but also in providing a tool for a thorough audit of the system to test the effectiveness of the system. It provides the manufacturer a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. Also it can help to minimize surprises and failures which might adversely affect patient safety and damage your reputation.

  • Minimise potential quality issues with 3rd party audit
    Certification of ISO 13485 Medical Devices allows us to perform regular audit on your system to ensure that you are constantly in compliance with regulatory laws to minimise quality issues.
  • Increase public image and accountability
    Certification demonstrate your commitment to quality assurance to your stakeholders and most importantly your potential customers.
  • Increases responsiveness to issues and nonconformities
    Through regular audit, our Client Managers can help you identify weaknesses within your processes before a crisis appears and recommends the best solution to close the gap.

Being BSI certified with ISO 13485 means that you will get access to the exclusive BSI Certification Mark that will help you demonstrate your commitment to quality within the medical devices industry. The BSI Certification Mark is an internationally recognised mark in over 86 countries and being used by more than 80,000 customers worldwide.

In short, you will be assessed and certified by one of the world’s leader on Standards-based solution. Our experienced Client Managers will work closely with you to establish a proper framework.



Further Information & Your Next Step

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