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Requirement of mentioning details of outsourced process in Clause 4.1.5 of ISO 13485

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Guest user Created:   Jun 18, 2020 Last commented:   Jun 18, 2020

Requirement of mentioning details of outsourced process in Clause 4.1.5 of ISO 13485

In the clause 4.1.5 of ISO 13485 (which talks about the outsourcing of any process by an organization), is it required to mention details of the outsourced process while drafting the document? And, can you elaborate on the controlling and documentation of such a process? If you can provide an example of how an organization documents clause 4 for the ISO 13485.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jun 18, 2020

In requirement 4.1.5 is stated that the control of the outsourced process should be written in the quality agreement. We in our ISO 13485 Documentation toolkit have a template for Quality agreement for critical suppliers. How template looks and which elements it has as you can find on the following link: 

Another part of this topic is how you will define in your Purchasing process control over companies that provide you outsourced processes. According to the requirement 7.4.1 Purchasing process, an organization must plan monitoring and evaluation of suppliers. Usually, manufacturers that have outsourced processes plan an audit in those companies in a frequency that they find justified. These audits are performed by the same rules as their internal audits.

You can find more information on how to control outsourced processes in the following article:

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Jun 18, 2020

Jun 18, 2020