ISO 13485, Part 1
Establishment, Exporter, FDA, Foreign, Importer, Manufacturer, QSR, Specification
This Device Tip was contributed by Judy Martin, an Associate with Bob Duffy Associates. Judy has over 25 years in the medical device and IVD industries, with experience in 510(k) submissions, design control, process improvement, recall management, product labeling development and FDA remediation activities. She has particular expertise in device promotion and advertising, including process development and claims substantiation, and extensive expertise in website promotion and regulatory aspects of social media promotion.
If your Quality Management System (QMS) is currently certified as compliant with ISO 13485:2003 (and/or EN/ISO 13485:2012) , certification in the EU will expire in February 2019. After February 2019, only certification to the latest edition of ISO 13485 published in 2016 will be valid in the EU.
This is the first tip in a series on the changes found in EN ISO 13485:2016. In order to be prepared (and here’s the tip):
Make a plan now to update your EN ISO 13485 certification to the 2016 edition to ensure continued certification for your Quality Management System in the EU.
These steps will help you prepare for the transition to the new revision of the standard:
- Contact your certification agency for scheduling a certification audit.
- Identify the changes between the 2003/2012 and the 2016 versions of the standard.
- Review your QMS procedures to determine where your processes are affected by the changes.
- Update any affected procedures to be compliant with the 2016 version.
- Provide training on changes to affected employees.
- Ensure all procedures and process are implemented.
More Info
There are a number of significant changes found in the 2016 update to EN ISO 13485 that will need to be incorporated into your processes in order to maintain certification in the EU. Just a few are listed here:
- Risk management – the 2016 standard expects that a risk-based approach will be applied to all QMS processes, not just during product realization.
- Outsourcing – there are new requirements to monitor and control outsourced processes that affect conformity with the standard and written quality agreements covering the outsourced processes are required.
- Design Transfer – there is a new section in the standard outlining requirements that must be documented for design transfer.
- Design and Development File and Medical Device File –new types of records required for devices.
- Product realization – there are new requirements for storage and handling, measuring, revalidation and traceability.
- Supplier Selection – new criteria are identified for supplier selection.
- Complaint Handling – this is a new section in the standard with requirements for complaint handling, including the requirement to notify any external party that contributed to the complaint.
- Regulatory requirements – there are new requirements included that address reporting of complaints and the expectation to comply with all regulatory requirements.
- Monitoring and Measuring- there is a new requirement to monitor post-production activities which are to be used as feedback into the risk management process and for process improvement.
- Non-conforming product – new sections have been added creating specific requirements for non-conformances found before and after delivery and for rework.
Maintaining your EN ISO 13485 certification is critical for selling your devices in the EU, so don’t wait until the last minute to begin the updating process to ensure that there is no gap in your certification status.