Implementing Design History Documents/ Technical Documents in the QMS

racglobal

Involved In Discussions
#1
I have a question regarding implementing design history/technical documents in the QMS. Technical documents are implemented through the engineering change order process. All stakeholders first sign off on the Engineering Change Order to approve the engineering changes (mostly from the engineering team). The documents have not been implemented in the QMS yet. The updated engineering documents then must be implemented in the QMS at which point there is change request form to complete with space for signature approvals. My question is, do the set of people who first approved the ECO changes also sign the change request form to implement these documents in the QMS? That creates a lot of signatures. If anyone has a simplified system for implementing technical documents, I look forward to your response.

Thanks.
 
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Tagin

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#2
I have a question regarding implementing design history/technical documents in the QMS. Technical documents are implemented through the engineering change order process. All stakeholders first sign off on the Engineering Change Order to approve the engineering changes (mostly from the engineering team). The documents have not been implemented in the QMS yet. The updated engineering documents then must be implemented in the QMS at which point there is change request form to complete with space for signature approvals. My question is, do the set of people who first approved the ECO changes also sign the change request form to implement these documents in the QMS? That creates a lot of signatures. If anyone has a simplified system for implementing technical documents, I look forward to your response.

Thanks.
I don't see any 13485 requirement that the document change approvals need to include the same personnel as the ECO approval.
 

indubioush

Quite Involved in Discussions
#3
Can you please clarify what you mean when you say "The documents have not been implemented in the QMS yet." Are you describing a two-step process in which the written description of change is approved first and then the documents are approved later? Are you locked in to the two-step process because you are using some sort of software? I would combine into one process if possible. If that is not possible, maybe you can have the engineering change only have one approval. The most important approvals are the approvals for the actual documents because it is their content that ends up in the technical file.
 

qualprod

Trusted Information Resource
#4
I have a question regarding implementing design history/technical documents in the QMS. Technical documents are implemented through the engineering change order process. All stakeholders first sign off on the Engineering Change Order to approve the engineering changes (mostly from the engineering team). The documents have not been implemented in the QMS yet. The updated engineering documents then must be implemented in the QMS at which point there is change request form to complete with space for signature approvals. My question is, do the set of people who first approved the ECO changes also sign the change request form to implement these documents in the QMS? That creates a lot of signatures. If anyone has a simplified system for implementing technical documents, I look forward to your response.

Thanks.
In fact you can manage two controls for the change in documents.
I have seen that there is one control for the document of the qms (audits, control of documents, etc) and there is other for the manage of technical documents (sometimes in AutoCAD , inventor).
 
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