Thank you for your excellent product. We are an ISO 9001:2015 certified company, and primary business function is the repair of surgical drills and saws used in orthopedic and oral surgeries sent to us at our facility by the user. We also do a small amount of contract manufacturing for orthopedic companies. At this time, nothing that we make or repair is implanted into a person during procedures; we only repair the tools used to perform the operations. There are several sections in the 13485 standard that we do not do; can you tell me if we are exempt? I am still trying to wrap my head around all of the provisions in the 13485 QMS and all of the required procedures.
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!!