Exclusion of requirements

ISO 13485 allows exclusion of certain requirements that are not applicable to the organization type of business and processes. Any requirement from clauses 6, 7 and 8 can be excluded if it is not applicable due to the activities that the organization performs or the nature of the medical device. For any clause that is excluded, the organization needs to provide documente d justification in the Quality Manual.

We do not have clean rooms or controlled areas. Are we required to have a procedure for Infrastructure and work environment?

It is hard to exclude the entire clause regarding the infrastructure. If you can say that in order to perform your services you don't need any infrastructure (buildings, utilities, process equipment, etc.), you can exclude this clause. On the other hand, the procedure for infrastructure doesn't have to be long or complicated, you can just write within you Quality Manual you requirements for infrastructure and avoid writing separate procedure. 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/

As far as the work environment is concerned, it would be safer to exclude only requirements for cleanliness and contamination control and to provide the rest of the information within the manual.

We do not design or develop any products, we only do repairs. Are we require to have a procedure for Design and Development? Our ISO 9001 QMS omits this section.

Yes, you can exclude requirements for design and development.

We do not sterilize anything before it leaves our facility, are we required to have a procedure for that?

Yes, you can exclude requirements for sterilization.

We do not use any software programs to test or validate any product we repair. The only software we have is inventory tracking, accounting, and AutoCad.

Yes, you can exclude requirements for validation of the software.

As a repair facility, we are not required to report any adverse incidents to any regulatory agency, do we need to have that procedure?

This requirement refers to the incidents and adverse effects that can happen to the end user or the patient and this is something that you should have.

Since we only do repairs, are we required to keep a medical device file?

Requirements for medical device file belongs to the clause 4.2.3 and cannot be excluded, but in you case, it should be provided by your customer or the manufacturer of the medical device.

Thank you for your help, and I look forward to asking you many more questions!!

Hi you state only clauses 6,7 & 8 can have exclusions yet software validation is in clause 4.1.6?

It does not refer to the validation of the software as a medical product. Requirement 4.1.5 refers to the validation of the software you use in your daily work, for example, software for monitoring the quantities of raw materials and finished goods in the warehouse, software in the machines you use to make your product, calibration software, and the like.

The validation of this software refers to checking whether anything has changed in your database supported by the software in question, in a situation where the software supplier informs you that it is necessary to update the software. And then, when you install a new version of the software, you must be sure that the new update has not disturbed anything in your data. For example, the software you use to issue invoices and delivery notes (and thus the stock balance) must continue with the update on the order number of invoices and delivery notes you ended with the previous day. This is what you have to check and validate.

Hi Kristina so my point is still vald then? You can't eliminate software validation if you state that only clauses in 6,7 & 8 can be justified exclusions. It clearly states in clause 4.1.6 "The organisation shall". Mr. Strahenja stated it can be excluded but this is not the case, it can only be excluded if you are not using software in product or process validation (clause 7.5.6). Am I missing something here? Thanks for your replies

Yes, you can not eliminate the process of software validation from your quality management system. But, if you are not using software for the validation process, then you can state that you do not use such software.    

@Andrew Rowe

Hi Kristina so my point is still vald then? You can't eliminate software validation if you state that only clauses in 6,7 & 8 can be justified exclusions. It clearly states in clause 4.1.6 "The organisation shall". Mr. Strahenja stated it can be excluded but this is not the case, it can only be excluded if you are not using software in product or process validation (clause 7.5.6). Am I missing something here? Thanks for your replies

Software validation may be exluded, or deeemed not applicable.

The article is wrong in that only 7.3 may be excluded (no point in having processes for R&D if you do not do R&D). Other articles from 6, 7 and 8 may be deemed not applicable if they are not done, or, outsourced.

Outsourcing then falls under 7.4 and 4.1.5, and 4.1.5 is not in 6, 7 or 8 ;)

Likewise, 4.1.6 applies to ALL software used in the company that relates to, or may affect processes, involved in medical devices or otherwise touches anything QMS related. It's not the software ON a device (that falls in 7.3 if you make it, or 7.3 & 7.4 & 4.1.5 if someone else does).

@Anthony

Software validation may be exluded, or deeemed not applicable.

* may not :)

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