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ISO_13485_Control_of_Documents_Responsibility_with_Authority

The document outlines the responsibilities and authorities of various roles in relation to the control of documents as per ISO 13485:2016. Management Representatives have full authority to implement and maintain document control procedures, while Process Owners and Department Heads are responsible for approving and ensuring alignment of documents within their departments. All employees are required to use current approved documents and report any outdated or incorrect materials.

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3 views1 page

ISO_13485_Control_of_Documents_Responsibility_with_Authority

The document outlines the responsibilities and authorities of various roles in relation to the control of documents as per ISO 13485:2016. Management Representatives have full authority to implement and maintain document control procedures, while Process Owners and Department Heads are responsible for approving and ensuring alignment of documents within their departments. All employees are required to use current approved documents and report any outdated or incorrect materials.

Uploaded by

rengasri13953
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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ISO 13485:2016 - Procedure for Control of Documents

Section: Users or Responsibility

Role/Position Responsibilities Authority


Management - Implement and maintain Full authority to control and
Representative the Document Control enforce document
Procedure. procedures across all
- Ensure only current, departments.
approved documents are
used.
- Maintain the master
document list and revision
history.
- Coordinate timely
document review and
approval.
- Control and remove
obsolete documents.
- Manage access to
electronic documents.
Process Owners / - Approve documents Authority to review and
Department Heads related to their approve documents within
departments. their department.
- Ensure documents align
with current practices.
- Recommend updates to
Management
Representative.
- Ensure staff are trained on
relevant documents.
All Employees - Use only current approved Authority to access and use
documents. documents relevant to their
- Report outdated or roles.
incorrect documents.
- Follow document control
procedures.
Top Management - Approve the Document Final authority on QMS
Control Procedure. policies and resource
- Allocate resources for allocation.
document control.

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