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Is there a requirement for periodically documents review?

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Guest user Created:   Jun 18, 2019 Last commented:   Jun 18, 2019

Is there a requirement for periodically documents review?

per ISO 13485, is there a requirement for periodically documents review? and if so, what is the scope (containment) of it? Does it apply to all controlled documents ( QMS Procedures/forms, SOPs, Work instructions, etc.. ) or only QMS procedures?
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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 Jun 18, 2019

Answer:

There are no strict requirements for a periodical document review. In the clause 4.2.4. b) is stated that update of documentation should be done as necessary .

It is, therefore, left to the choice of every organization to assess this period on their own, and to set the criteria that will determine the periodical update. The purpose of the periodic review of documents is to make sure that all processes are carried out as described. There are often times that someone accidentally makes a small change in the steps, so once the colleagues take over the project, there is a discrepancy between what was provided in the first place and what was later done.

Therefore, when determining how often you will review your documents, consider the following:
1) whether there was a large fluctuation of people
2) whether you have changed equipment, facilities, resources, location
3) whether the managers of individual processes have changed and brought some of their own policies and practices.

It is common that the documentation is reviewed every two to three years, and, in extremely small companies, with 3 to 5 people, it is possible to review it every 5 years.

To learn more about other most common errors in the documentation control, please refer to this article: https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/ .
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Jun 18, 2019

Jun 18, 2019

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