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Systemic requirements
4.1 Organizational requirements
4.1.1 Establish a QMS.
Develop a QMS for your organization.
Meet all applicable ISO 13485 requirements.
Meet all applicable regulatory requirements.
Document your organization's QMS.
Implement your organization's QMS.
Carry out all required QMS activities.
Carry out all required ISO 13485 activities.
Carry out all required regulatory activities.
Follow all required QMS procedures.
Follow all required ISO 13485 procedures.
Follow all required regulatory procedures.
Apply all required QMS arrangements.
Apply all required ISO 13485 arrangements.
Apply all required regulatory arrangements.
Maintain your organization's QMS.
4.1.2 Clarify structure.
Consider the roles that regulators expect you to perform.
Determine the processes that your organization's QMS needs.
5. Management requirements
5.1 Commitment requirements.
Demonstrate your ongoing commitment.
Support the development of your QMS.
Support the implementation of your QMS.
Support the maintenance of your QMS.
6. Resource requirements
6.1 Allocation requirements.
Determine the resources that your QMS needs.
Provide the resources that your QMS needs.
7. Realization requirements
8. Remedial requirements
8.1 Planning requirements
Plan monitoring, measurement, and analytical processes..
Plan how monitoring methods will be used ensure conformity and
effectiveness.
Plan how measurement will be used to ensure conformity and
effectiveness.
Plan how analytics will be used to ensure conformity and
effectiveness.