Things to keep in mind when reviewing standards

There are things to be look out before reviewing standards.Some standards are superseded by other standards with different document numbers (e.g., DS/EN 550 supersedes DS/EN ISO 11135-1).

There are some situations in which a document number from one standards organization might be revised or superseded, while another standards organization’s document remains current (e.g., ISO 11137-1 gets revised or superseded, but DIN EN ISO 11137-1 remains current). Please review the forms and lists carefully to ensure that you are working with those standards to which your facility claims compliance.

If a form cites an ISO standard, such as ISO 13485, and your facility is compliant to an equivalent, such as BS ISO 13485, please mention this on the form.

This entry was posted in ISO 13485, ISO discussion, Training and tagged , , , , , , , . Bookmark the permalink.

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