Outsourced Processes Quality Agreements

[ernieto]

When the organization chooses to outsource any process that affects product conformity with requirements, it shall monitor and ensure control over such processes. The organization shall retain responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for outsourced processes. The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4. The controls shall include written quality agreements.

I had a discussion about this during an audit and want to know other people's opinion. what processes should be included here: translation services, third parties doing internal audits, calibration, pest control... I am curious about the argument against "process that affects product conformity".

 

[Tagin]

It's really difficult when they use vague wording like that because so much is open to interpretation. TS9002/2016 can be somewhat helpful. An example it provides is as follows:

EXAMPLE In a printing organization, the paper quality could be critical. However, a travel agency might use normal, commercial stationery without the need for any quality related purchasing controls. The printing organization needs to monitor the performance of its paper providers very closely to ensure that the quality of its printed products remains at the expected level.

 

[Ed Panek]

Its risk-based. For our group we use an SQA to make sure they maintain an ISO certification in their respective standard(s), track defects pre and post-shipment, notify us of any of their supplier changes or specification changes, technology changes, ownership changes, claims, disclaimers, etc.

 

[Sidney Vianna]

TS9002/2016 can be somewhat helpful.

A better guidance document for the context at hand is the ISO booklet titled ISO 13485:2016 - Medical Devices - A practical guide. A snapshot of the document concerning the issue at hand is posted below.

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[ernieto]

A better guidance document for the context at hand is the ISO booklet titled ISO 13485:2016 - Medical Devices - A practical guide. A snapshot of the document concerning the issue at hand is posted below.

View attachment 28527​

Thanks