ISO 13485 audit checklist about management review
ISO 13485 audit checklist about management review
Clause 5.6
5.6.1 General
• What is the frequency that top management reviews the organization’s QMS?
• What kinds of information are reviewed in management reviews? (must include suitability, adequacy and effectiveness of QMS; improvement; & changes to the QMS, quality policy and objectives)
• Can you show me records from recent management reviews?
5.6.2 Review input
Can you show me that each of the following were included in review(s)?
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement, and
new or revised regulatory requirements.
5.6.3 Review output
What decisions or actions have resulted from management reviews for each of the following?
a) improvement needed to maintain the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.
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