ISO 13485 audit checklist about responsibility, authority and communication
ISO 13485 audit checklist about responsibility, authority and communication
Clause 5.5
5.5.1 Responsibility and authority
How are responsibilities and authorities defined, documented and communicated within the organization? (Verify throughout audit)
5.5.2 Management representative
Who is your ISO 9001:2000 management representative?
Does the management representative have responsibility and authority to
a) ensure that processes needed for the QMS are established, implemented and maintained?
b) report to top management on the performance of the QMS and any need for improvement?
c) ensure the promotion of awareness of regulatory and customer requirements throughout the organization?
5.5.3 Internal communication
How is information regarding the effectiveness of the QMS communicated within the organization?
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