Achieve ISO 13485 certification for your business
Demonstrate to customers the company’s ability to meet customer requirements and legal obligations
ISO 13485 – Medical Devices Management System
ISO 13485 is an internationally recognised standard that represents the requirement for a comprehensive management system where an organisation needs to demonstrate its ability to safely manufacture medical devices as well as related services that consistently meet or exceed customer requirements and legal obligations.
Whilst it is a stand-alone document, it is generally harmonised with ISO 9001, the Quality Management System.
Why seek ISO 13485 certification?
If you are a medical manufacturing company you will require a formal quality management system or if you are an existing organisation moving into the medical device or medicines manufacturing industry you will under current legislation need to become ISO 13485 compliant.
ISO 13485 conformance is important because the conformity of medical devices and in vitro diagnostic medical devices according to EEC regulations must be assessed before the sale of the device is permitted within the European Union.
What are the benefits of ISO 13485?
Most companies opt to achieve certification for the following business reasons:
- Allows access to some international markets
- Serves as the basis for QMS compliance in other countries
- Increases additional credibility with potential customers
- Increases efficiency and enhances product quality
- Customer satisfaction by meeting customer requirements
- Prospective reduction in costs and improved performance
- More effective risk management process
- Reduces potential harm to user or patient
- Meet legal, regulatory, contractual and marketing requirements
- Improved stakeholder relationships