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Changes in kit manual or kit inset

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Guest user Created:   Sep 26, 2019 Last commented:   Oct 02, 2019

Changes in kit manual or kit inset

I work for a company in the field of PCR based Molecular Diagnostic Kits.The Company is ISO 13485:2016 certified. I have a question regarding the manuals of the kits. If we do some changes in our manual or update our kit format, whether that will come under version change or simple amendment changes. How we should document it?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Oct 02, 2019

Instruction for Use (IFU) for In-vitro medical devices (IVD) must have unique reference to identify the right version of the IFU. This reference should allow the user to retrieve the applicable IFU. Usually, this unique reference mark is in small letter size put somewhere in the corner of the IFU. Each time you change something in the IFU, you need to mark the new revision of the IFU. Changes are best to be documented through the change control process. According to the ISO 13485 4.2.4 c) you need to ensure to differentiate different versions of the documents, and h) to prevent unintended use of obsolete documents.

On the following link you can find information on what information must be in the IFU and what is the purpose of Unique reference number: https://ec.europa.eu/docsroom/documents/10293/attachments/1/translations

For more about what are common mistakes in ISO 13485 documentation control please read the following article: 

Common mistakes with ISO 13485:2016 documentation control and how to avoid them  https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/

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Sep 26, 2019

Oct 02, 2019

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