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Inventory management

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Guest user Created:   Nov 11, 2020 Last commented:   Nov 12, 2020

Inventory management

How is inventory management written in the ISO 13485?

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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 Nov 12, 2020

There is no direct requirement in the ISO 13485:2016 that cover inventory management. In requirement 5.1 Management commitment is stated that management must ensure the availability of resources. Furthermore, in 6.1 Provision of resources is stated that top management must determine and provide resources needed to implement the quality management system and to meet applicable regulatory and customer requirements.

Inventory management usually considering to determine the vital stock levels. Following steps can be used to control your stock levels: establishing levels of operating stocks based on consumption/rate of usage; maintain periodically stock usage reports of each item kept in the store; establishing quantity, lead time, and availability of each item supplied on the market; keeping a record of all non-stock items received from suppliers, returned to suppliers and issued out to users.

Of course, as inventory management important is to have under control shelf life of both raw and packaging material and final goods; to follow the FIFO (first in first out) or FEFO (first expire first out) principle, which you find most useful for your type of production. 

The following article can be helpful:

You can see how we describe this process in our procedure for warehousing in our ISO 13485:2016 documentation toolkit:

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Nov 11, 2020

Nov 12, 2020