Medical devices must be of high quality to be considered safe on the market. Strict safety and quality regulations must be met to achieve this. In this article, we’re answering the question – what is ISO 13485?
What is ISO 13485?
ISO 13485 is an international standard for mapping what is required from a medical device. The system ensures that medical devices are effective and consistent throughout their life cycle, from planning and production to disposal.
Ensuring consistency is extremely important for medical devices, as patient safety could be at risk. Implementing quality management systems can also provide protection for manufacturers and their reputations, as risks can be easily identified and rectified.
Medical device regulation varies based on the classification of the medical device being manufactured. All parties are required to demonstrate compliance, from the medical device manufacturing process to the disposal of the product.
Who is the ISO 13485 medical devices quality management system for?
An ISO 13485 Quality Management System is designed for anyone involved with the production of medical devices. These include:
- Medical device manufacturers
- Distributors (MDR requirement)
ISO 13485 medical devices
The current version is ISO 13485:2016. This quality management system is used for CE-marked products on the European market under European Medical Device Directives (EU MDD) and UKCA-marked products under UK MDR 2002.
The UK market currently accepts products with either the CE marking or the UKCA marking. However, after July 2024, products will need a UKCA marking to be sold legally in the UK.
These markings indicate that medical devices have met strict regulations and are safe for their intended use. A Notified Body can assist with product safety markings for countries in the European Union or the UK.
ISO 13485 implementation guide
There are eight sections in the ISO 13485 quality management system, and these include an introduction, references and conditions, as well as the following:
- Quality management system: General Requirements & Documentation Requirements
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis & Improvement
To successfully implement this quality management system, all of these clauses must be considered and adhered to accordingly.
What is the difference between ISO 13485 and ISO 9001?
ISO 9001 is a well-recognised quality system that can be used by any industry, whereas ISO 13485 is specifically designed for the medical device industry. ISO 13485 covers all aspects of ISO 9001, with some additional elements relevant to the medical industry.
Both quality management systems follow the plan, do, check, act structure, allowing any issues to be identified. In addition, they both focus on risk management, ensuring employees are aware of procedures and assessing quality based on the product’s end user. This allows the device to consistently meet customer or patient requirements.
ISO 13485 outlines that all documentation changes must be submitted for management review. Information on individual products and regulations must be included within the documentation.
Where ISO 9001 assigns various roles to members of a team, ISO 13485 assigns a member of the team to be responsible for the quality management system. Other team members can still work on the quality management system; however, the assigned individual is responsible.
Information regarding the work environment, cleaning and risk management must be included in the ISO 13485 documentation. There should also be processes in place for dealing with any advisories.
ISO 13485 highlights the need for products to be traceable. This can be achieved by providing batch information. Medical device instructions should also be outlined, in addition to information regarding the cleanliness of the device and how expiry dates are managed and adhered to.
Measurement, analysis and improvement of products
This involves ensuring that each medical device meets applicable regulatory requirements and that all procedures are in place should there be an issue with a device. When data becomes available, it should be correctly analysed, and plans can be made to improve the production or outcome of the medical device.
Quality management systems place a significant focus on the continuous improvement of products, specifically for the end user.
ISO 13485 implementation plan
When implementing any quality management system, it is essential to be clear and concise. At Patient Guard, we can support you with ISO 13485 implementation. We will work closely with you and adjust our approach based on your requirements.
The ISO 13485 implementation and certification process typically takes around 8 to 12 weeks. This quality management system requires staff training and the completion of new written procedures. Having the system in place makes internal and external auditing much more efficient.
ISO 13485 standard summary
Why should you implement ISO 13485? This quality management system is designed for those dealing with medical devices. It allows you to assess your processes and improve them to promote product development. In addition, ISO 13485 2016 can act as a quality manual for your team.
We hope this article has been helpful. Don’t hesitate to contact us if you need support implementing ISO 13485 or any other quality management system. Our experienced team can support you with all aspects of quality assurance.