Management
Review
Date: Month DD, 20YY
Location: Misc. Conference Room
Management Representative: First Last
Management Review
Agenda
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Roll Call of Attendees (5.6.1)
Results of Audits:1st party, 2nd party & 3rd party (5.6.2a)
Customer Feedback (5.6.2b)
Process Performance & Product Conformity (5.6.2c)
Status of Preventive and Corrective Actions (5.6.2d)
Follow-up Actions from Previous Management Reviews (5.6.2e)
Changes that Could Affect the QMS (5.6.2f)
Recommendations for Improvement (5.6.2g)
New or Revised Regulatory Requirements (5.6.2h)
Suitability of Quality Policy (5.3e)
Status of Quality Objectives (5.4.1)
Risk Management Process Effectiveness (3.2 in 14971:2007)
Improvements Needed to Maintain QMS Effectiveness (5.6.3a)
Improvement of Product Related to Customer Requirements (5.6.3b)
Resource Needs (5.6.3c)
Review New Action Items
2
Management Review
Roll Call of Attendees (5.6.1)
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?, CEO/President
?, VP & CFO
?, Director HR
?, Operations
?, Supply Chain Manager
?, VP Marketing
?, VP US Sales
?, VP Int’l Sales
?, Faciliities
?, VP R&D
?, Director of Quality (Management Representative)
?, Regulatory Affairs Manager (Back-up Mngt. Rep.)
Names and titles need to be reviewed. Only “TOP MANAGEMENT” and the MNGT
rep are required. The quorum can be as small as the GM and MNGT REP.
3
Management Review
Results of Audits:1st, 2nd & 3rd Party (5.6.2a)
4
Management Review
Customer Feedback (5.6.2b)
5
Management Review
Process Performance & Product Conformity (5.6.2c)
6
Management Review
Status of Preventive and Corrective Actions (5.6.2d)
7
Management Review
Follow-up Actions from Previous Management Reviews (5.6.2e)
8
Management Review
Changes that Could Affect the QMS (5.6.2f)
9
Management Review
Recommendations for Improvement (5.6.2g)
10
Management Review
New or Revised Regulatory Requirements (5.6.2h)
11
Management Review
Suitability of Quality Policy (5.3e)
12
Management Review
Status of Quality Objectives (5.4.1)
13
Management Review
Risk Management Process Effectiveness (3.2 in 14971:2007)
14
Management Review
Improvements Needed to Maintain QMS Effectiveness (5.6.3a)
15
Management Review
Improvement of Product Related to Customer Requirements (5.6.3b)
16
Management Review
Resource Needs (5.6.3c)
17
Management Review
Review New Action Items (5.1)
The QMS continues to be effective except for the areas
where action items are being initiated. Those areas are
as follows:
1. Action Item…
18