ISO 13485 Medical Devices FAQ
- 1. What is ISO 13485?
- ISO 13485 is the globally recognised management systems standard
for the design, manufacture, installation and servicing of medical devices.
It is a framework to facilitate compliance with the differing regulatory
requirements of different marketplaces around the world.
- 2. What are the key requirements of ISO 13485?
- While encompassing the core elements of the ISO 9001 Quality
Management System, ISO 13485 differs in a number of respects. The primary
difference is its focus on regulatory compliance rather than customer satisfaction
or continuous improvement as found in ISO 9001. Other key elements
include:
- A strong focus on risk management in the design and development process
- Product traceability and recall
- Process validation
- 3. What are the benefits of ISO 13485 compliance?
- The primary benefit for most organisations operating at
any tier of the medical device supply chain is the enhanced ability to win
business in this sector – particularly when non ISO13485 cetificated
organisations may be excluded from the procurement process. However
there are other benefits including:
- Improved standing in the marketplace
- Higher levels of customer satisfaction
- Improved efficiency from improved working practice
- Improved management of risk
- 4. How can HPA help?
- Through every stage of the process, Hatton Parkinson
Associates
can help your business to prepare for third party assessment for
the ISO 13485
standard. We partner with you at every step to make sure the whole
compliance experience is as simple and cost effective as it can be.
- 5. What does this cost?
- The straightforward answer is that ISO 13485 certification
does not cost that much compared to the benefits of becoming registered.
Government grants of up to half the fees may be available. Our own
in-house payment plan options can also help to spread the cost.
