Joint approval between OEM and Manufacturer on Design Documents

#1
My company (the manufacturer) is in a partnership with an OEM, who is the Design Owner and Contract Manufacturer to develop an instrument. As we are planning our design documents, the OEM company would like my company to sign their Product Requirements Document (PRD) and Product Specifications Document (PSD). We both have separate Quality Management Systems. I have a question if our staff signs the OEMs template document, would we be affecting ISO 13485:2016 section 6.2 (b) provide training or take other actions to achieve or maintain the necessary competence.

Can the manufacturer sign the OEM's requirements and specs documents?
Do we need to write a justification explaining the role of the manufacturer as signees of the document?

The manufacturer does not plan on being trained on the OEM's processes and QMS. Thanks in advance for your help.
 
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William55401

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#2
Signing the CM (contract mfr) documents is very normal. It is part of oversight / supplier controls. 13485:2016 explicitly calls out that quality agreements shall be established. Who signs what? How do we work together (from a QMS perspective) is addressed in the quality agreement(s). Often, firms may have a quality agreement that covers development (the project / pre production phase)-- it could also be covered by having both parties sign the development project plan. Another quality agreement document would cover production.
 
#3
Signing the CM (contract mfr) documents is very normal. It is part of oversight / supplier controls. 13485:2016 explicitly calls out that quality agreements shall be established. Who signs what? How do we work together (from a QMS perspective) is addressed in the quality agreement(s). Often, firms may have a quality agreement that covers development (the project / pre production phase)-- it could also be covered by having both parties sign the development project plan. Another quality agreement document would cover production.
Thank you for your response. I agree in quality agreements can define who signs which documents. I’m wondering how do we explain that it’s acceptable for another company to signed a design control document if those individuals are not trained in the process.
 

William55401

Involved In Discussions
#4
You are signing as a customer not an owner / active employee in the supplier's QMS. It is up to your supplier to implement the requirements. Feel free to include disclaimers like this in the signature block. As the development progresses, your firm (the customer) will likely verify and validate certain elements of the design
 
#5
Thank you. I plan to ask the supplier to define my company’s role and responsibility either in the signed document or in a project/development plan. I appreciate the feedback you provided.
 
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