ISO 13485 Importance
The Importance of ISO 13485:2016
When it comes to medical device manufacturing, patient safety depends on the quality and consistency of medical products. Ensuring the effectiveness, control and maintenance of your Quality Management System (QMS) is critical to customers, stakeholders, patients and users, and regulatory agencies.
The value of ISO 13485:2016 is not just in the implementation but also:
- In providing a tool for a thorough audit to test the system's effectiveness.
- It gives the manufacturer a higher confidence level in consistently achieving and maintaining compliance with regulatory requirements.
- It can also help to minimise surprises and failures which might adversely affect patient safety and damage a manufacturer's reputation.
- Manufacturers are more likely to win new customers by having a fully functional and certified QMS according to the requirements of ISO 13485:2016.
ISO 13485:2016 and the CE Mark
ISO 13485:2016 is the standard for quality management systems and is accepted as the basis for CE marking medical devices under EU Medical Device and IVD Regulations as well as the UKCA marking of medical devices under the UK MDR 2002. ISO 13485:2016 remains a state-of-the-art document.
Is ISO 13485 mandatory?
The quick answer is NO; ISO 13485 is not mandatory. Why is everyone talking about it?
When it comes to quality management systems, organisations can create a QMS as per their needs ensuring complete compliance with legal and regulatory requirements. Considering QMS and EU MDR, Medical Device Manufacturers must have a QMS in place, and the ISO 13485:2016 is the only QMS standard listed in the EU harmonised standard list. Since ISO 13485:2016 is mentioned in the harmonised European Standards (hENs) 's list, it can be interpreted that with ISO 13485:2016 – the mandatory requirement for having a QMS, as listed under EU MDR, is met. An ISO 13485:2016 certified company need not worry about QMS requirements.
ISO 13485:2016 provides you with more than the bare minimum to meet a legal requirement; it provides a whole system devoted to helping you improve your company’s quality processes.
What are the benefits of being certified to ISO 13485:2016?
As listed by the BSI
High-performing organisations expect ISO 13485 auditing to be thorough, competent, relevant and challenging to the manufacturers' QMS. Effective auditing provides significant benefits for the manufacturer. The beneficial outputs of an effective audit include:
- Meaningful feedback on the effectiveness of the quality management system
- Confidence in compliance with regulations
- Identification of areas requiring attention
- Detection of areas of non-compliance and risk
- Reporting and certification that is valuable and recognised
In conclusion to our previous blog and this blog, Medical Device Manufacturers need to focus on having a robust QMS in place. Our RAQA Advisers can help you with this!
Book a FREE 30 Minute One-2-One call with one of our RAQA Advisers by sending an email to: mdd@mddltd.com
