Gap Analysis for ISO 13485:2016

Lloyd’s Register Gap Analysis assessment examines and reports on your management systems’ readiness for transition. It focuses on how your management system has addressed, or plans to address, the changes introduced through the publication in ISO 13485:2016. Based upon the findings, your assessor will advise whether your organisation is ready for assessment or indicate areas requiring further attention.

By clearly identifying any weaknesses or ‘gaps’ in your management system, our assessors will be able to discuss what needs to be addressed as well as any concerns you may have regarding your system or the assessment process.

In addition to our Gap Analysis assessment, LRQA provides a range of face-to-face assessment services suitable for organisations of all sizes, which help to determine your organisation’s state of preparedness for transition to ISO 13485:2016. For more information call us on 0800 783 2179 or complete our enquiry form.

Click on the image below to download Gap Analysis for ISO 13485:2016

Image - ISO 13485:2016 Gap Analysis download