Have your say – Time for changes to ISO 13485?
ISO 13485:2016 - Medical Devices - Quality Management Systems - Requirement for regulatory purposes
ISO 13485 is a key standard for the Medical Device sector, with the current edition published in 2016. This standard is now at systematic review and is currently open for feedback.
The Standard development process involves a review of published standards to assess the continued suitability of the standard and to identify any need for change.
NSAI would like to hear from users of this standard on the need for possible change. This feedback will inform the NSAI national position for feedback to ISO (International Standards Organisation) on the systematic review of this standard.
Opportunity to provide feedback on future revision of ISO 13485
A short survey has been developed that will allow users of this standard to provide feedback and highlight specific areas of the standard that may require change. Please answer all questions that are applicable to you and your feedback.
It is advisable to review the standard in advance of completing the survey to identify areas that may require revisions. This will assist in answering the questions of survey.
Please complete the current survey by 5.00pm April 14th, 2025
If you would like to provide more detailed feedback on specific clauses of ISO 13485, please email standardsmailbox@nsai.ie
Results of the survey will be reviewed by members of NSAI/TC 5 Healthcare Standards Consultative Committee (HCSC), for the purposes of providing feedback to ISO on the Systematic review. Contact details will not be shared but they may be used by NSAI for communication purposes, such as feedback on the survey results.
For more information on national standard committees in the healthcare and lifescience area, see the NSAI website.
