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Requirements for infrastructure

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Guest user Created:   May 04, 2018 Last commented:   May 04, 2018

Requirements for infrastructure

Regarding the ISO 13485:2016 PR 05 Procedure for Infrastructure and Work Environment: 95% of our business is repair of surgical drills and saws. The other 5% of our business is contract manufacturing for OEM surgical device makers. We do not manufacture complete medical devices in our facility. We do not have clean rooms, and we don't test our air quality for microbiological or particulates. What all is actually required in our procedure as far as the standard is concerned?
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Step-by-step implementation for smaller companies.

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Strahinja Stojanovic May 04, 2018

Answer:

ISO 13485 allows exclusions of any requirements from clauses 6, 7 and 8, if they are not applicable to the type of business your organization is performing. Of course, as long as you can provide justification for the exclusion.

Requirements for infrastructure can hardly be excluded, because you still use some kind of equipment, and the entire point of this clause is to define and plan maintenance activities .

Work environment requirements, on the other hand are probably not entirely applicable to your type of business, so you can exclude requirements fo r cleanliness and clothing of personnel (clause 6.4.1) and contamination control (clause 6.4.2).

All the parts of the Procedure for Infrastructure and Work Environment that are not applicable to your type of business can be either edited or completely deleted.

For more information, see: Managing medical device infrastructure requirements according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/
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May 04, 2018

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