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ISO 13485 FOR MEDICAL DEVICES
ISO 13485 QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES
ENSURING THE QUALITY AND SAFETY OF MEDICAL DEVICES
In the heavily regulated medical industry, it is absolutely essential that products are safe and fit for their intended purpose. ISO 13485 is an internationally-recognised standard that helps manufacturers of medical devices to ensure the quality of their products and help maintain patient safety.
Bureau Veritas is a Certified Body, working with organisations to audit their performance against and certify to the ISO 13485 standard.
WHAT IS ISO 13485?
ISO 13485 Quality Management System for Medical Device Manufacturing is based on the global ISO 9001 Quality Management System standard.
It provides a framework for effective Quality Management Systems, designed specifically to achieve regulatory compliance in the manufacture of medical devices. In doing so, ISO 13485 ensures the consistent design, development, production, installation, delivery and disposal of medical devices that are safe for their intended purpose.
The standard is applicable for manufacturers of medical devices and organisations whose services support manufacturers.
THE BENEFITS OF ISO 13485 CERTIFICATION
- Improve Quality Management Systems to mitigate risk throughout your supply chain
- Meet regulatory demand for safe medical devices
- Provide confidence for stakeholders and maintain patient safety
- Reduce safety and legal risks
- Drive cost savings through operational efficiencies
- Access medical markets through compliance with international guidelines
WHAT IS THE DIFFERENCE BETWEEN ISO 9001 AND ISO 13485?
ISO 9001 is an internationally recognised standard for any organisation, in any industry. ISO 13485 is based on ISO 9001, but with additional requirements that are specific for those involved in the manufacture of medical devices.
Importantly, ISO 13485 is aligned with ISO 9001:2008 and not ISO 9001:2015. This is because ISO 13485 was revised in parallel with ISO 9001 and ISO 9001:2015 was deemed not suitable for medical devices.
Any organisation certified to ISO 13485 will meet the requirements of the EU Medical Device Directive and the EDU Medical Device Regulation.
WHY USE BUREAU VERITAS FOR ISO 13485 CERTIFICATION?
Bureau Veritas combines certification expertise with regulatory understanding and industry experience to support you in achieving and maintaining ISO 13485 certification. We have a global team of auditors able to assess your performance against the standard, as well as flexible training solutions.
- Certification specialists, with more than 40 national and international accreditations worldwide
- A true global leader, having issued more than 150,000 ISO certificates
- Align with other standards and drive efficiencies through our comprehensive certification offer
- Global network of auditors with local knowledge – we have more than 7,400 skilled auditors across the world
- Complete peace of mind from an impartial, independent third-party
- Access to a full range of certification and audit services covering quality, health, safety, sustainability, environmental and more
- Flexible training solutions
