ISO 13485 Exclusions - Production-related requirements - Section 7.5

P

PhilT

#1
I have to create a quality system for a small medical device company that performs design and development functions- gains permission to market the devices (FDA clearance, CE Mark, etc.); and then subcontracts manufacturing of the devices to other companies. It is not, and will not be, actively engaged in manufacturing of product for human (other than possible clinical trial) use,but it does release the product to its distributors that is produced by the contract manufacturer.

I have attempted to address its "production" functions under its product realization activities by calling them "design transfer", which allows it to teach the methods and transfer specifications it developed, verified, and validated during the design phase. However, this does not cover the product release activities it performs.

Because it releases the product, do all of the production-related requirements of Section 7.5 need to be addressed in the quality system, or do I only need to address product release? I have attempted to only address product release. Has anyone had experience with this, or similar situations? If so, did they obtain buy off from their NB? the FDA?

Any thoughts, and especially reports of any experience with this situation, would be appreciated.

Thanks!
Phil :frust:
 
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Al Rosen

Staff member
Super Moderator
#3
PhilT said:
I have to create a quality system for a small medical device company that performs design and development functions- gains permission to market the devices (FDA clearance, CE Mark, etc.); and then subcontracts manufacturing of the devices to other companies. It is not, and will not be, actively engaged in manufacturing of product for human (other than possible clinical trial) use,but it does release the product to its distributors that is produced by the contract manufacturer.

I have attempted to address its "production" functions under its product realization activities by calling them "design transfer", which allows it to teach the methods and transfer specifications it developed, verified, and validated during the design phase. However, this does not cover the product release activities it performs.

Because it releases the product, do all of the production-related requirements of Section 7.5 need to be addressed in the quality system, or do I only need to address product release? I have attempted to only address product release. Has anyone had experience with this, or similar situations? If so, did they obtain buy off from their NB? the FDA?

Any thoughts, and especially reports of any experience with this situation, would be appreciated.

Thanks!
Phil :frust:
I think if you don't perform a function you should just take an exclusion. Design transfer activities are covered in 7.3. I think covering it in production may muddy things. Your purchasing procedures might reflect the use of and tight control over a contract mfr.
 
Q

qualitygoddess - 2010

#4
I recently worked with a client and we were very careful to explain exclusions in the policies manual in section 7.5. Of course, we only excluded those 7.5 process steps that could be excluded. Even as careful as we were, the auditor still managed to find two we missed.

Somewhere on the Cove someone posted a great little checklist that highlighted the 13485 requirements in blue text and the ISO 9001 requirements in black text. It was a great help to me in learning the differences between 13485 and 9001.

--QG
 
R

rose24m03

#6
exclusion vs non applicability for ISO 13485:2003

"Exclusion" is usually used for clause 7.3.

"Non applicability" is used for product realization requirements that are NOT applicable due to THE NATURE OF THE MEDICAL DEVICE. Guidance has a good example on how Non Applicability is used.


In your case, your product realization processes related to post R&D are required for your device (thus you cannot claim "non applicability" in your QS) but are outsourced to your contract manufacturers (which ISO 13485:2003 clause 4.1 requirement on control of outsourced processes needs to be addressed in your QS). You need to ensure that the device manufactured (regardless by whom) is the one that you verified and validated in your design controls process (thus how will you control contract manufacturers and ensure that nonconforming devices would not be accidentally released). You also need to assure that you are getting feedback for improvement (hence ISO 13485:2003 clauses 8.1, 8.2.1, 8.2.3, 8.2.4, 8.4, 8.5.1) from your contract manufacturers and customers on products AND processes (via supplier/contractor management, internal audits, CAPA etc for examples).

Guidance document ISO/TR 14969:2004 is a good source document to help you interpret ISO 13485:2003 requirements.
 
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