ISO 13485 : 2016
Work with a local ISO 13485 consultant.
An ISO 13485 consultant and certified ISO auditor can:
- Provide training and value-added consulting services to ISO 13485
- Build a new ISO 13485 management System
- Implement system upgrades
- Resolve audit findings
- Perform internal audits
- Witness audits
ISO 13485 lays out the needs for a Quality Management System (QMS) specific to medical devices. It is meant for businesses supporting the medical device supply chain. A good system helps you improve the quality of your products and services. Many OEMs and governments require their suppliers to be certified so it can also help you grow your business.
If you are working towards an ISO 13485 certificate, we can guide you through the process. We can provide a small amount of help, or build a complete robust system, depending on your needs. We can also help you select an auditor. Working with trusted colleagues can help the process go more smoothly.
Every WP Group ISO 13485 consultant is a certified ISO auditor so we are in the best position to help you build a highly effective system and pass your audit.
We can also help you with related programs and regulations such as MDSAP and 21 CFR.
ISO 13485 is based on ISO 9001, the most widely used quality standard. The newly revised ISO 13485:2016 is the standard specific to medical devices. It incorporates many of the QMS principles of ISO 9001 with enhanced requirements for regulatory compliance.
ISO 13485:2016 is a stand-alone standard. This means an organization can become certified to this standard without also implementing ISO 9001:2015. However, many companies certify to both ISO 9001 and ISO 13485 to ensure a comprehensive and robust QMS.
ISO 13485 is published by the International Organization for Standardization (ISO).