Document Name Document Code 1.0 Purpose
The purpose of this procedure is to define DaMei
’s requirements for conducting Management Reviews.
Management Review Procedure
QM-COP-03
Edited/Revised
Date
Page Code
1/4Version Issued Date
A/0 2018.10.24
2018.10.24
2.0 Scope
This procedure is the primary document meeting the applicable regulatory requirements for conducting Management Reviews as defined in DaMeiReferences and Relationships ISO 13485:2016 21 CFR 820.20
’ｓ Quality System Manual (QM-A-01).
3.0 Responsibilities and Authorities Role
Quality Management / Management Representative Top Management
Responsibilities and Authorities
Primary responsibility for maintaining this process and ensuring that Management Review meetings are scheduled, conducted and the minutes are recorded.
The Management responsible for attending Management Review Meetings as identified in DaMei
’ｓ organization chart. These managers are
—including the
responsible for participating in Management Reviews
preparation of inputs to the Management Review and completion of action items resulting from Management Reviews. The organization chart should also identify the following personnel: Management Representative Deputy Management Representative Most Senior Executive Manager Second Most Senior Executive Manager
It is not recommended to have the same person hold two of the above four positions.
4.0 Procedure 1 2
Management Review meetings shall be scheduled at least once a year.
The following inputs are required to the Management Review meeting for discussion: Quality policy Quality objectives Results of audits
– including internal, supplier, certification audits and FDA inspections – including complaints and post-market surveillance If this manual is printed, it is an UNCONTROLLED
copy.
Customer feedback
Dongguan XXXX Limited
Document Name Document Code
Management Review Procedure
QM-COP-03
Edited/Revised
Date
Page Code
2/4Version Issued Date
A/0 2018.10.24
2018.10.24
Process performance Product conformity
Supplier quality performance
Status of corrective and preventive actions
Follow-up of action items from the previous Management Review(s) Changes that could affect the quality system Recommendations for improvement New and revised regulatory requirements Risk management process (ISO 14971) Overall quality system effectiveness
3
Management Review inputs shall be documented in a presentation slide deck using a controlled template. The Management Representative shall assign responsibility for completing each slide of the presentation as an action item in the previous Management Review. These assignments shall be documented in the meeting minutes. Each input slide shall be provided to the
Management Representative at least 10 calendar days prior to the planned review date, and the Management Representative shall combine the slides into a draft presentation and
electronically deliver the draft presentation to Top Management at least 7 calendar days prior to the planned review date. Any necessary corrections to slides should be communicated to the Management Representative as soon as possible so that corrections can be communicated to Top Management prior to the planned review date.
4
During the Management Review, Top Management shall review the Quality Policy to ensure it: is appropriate to DaMei
’ｓ purpose,
includes a commitment to comply with requirements and to maintainthe effectiveness of the quality management system,
provides a framework for establishing and reviewing qualityobjectives, is communicated and understood within the organization, and
is reviewed for continuing suitability during at least one Management Review meeting each year.
5
During the Management Review meeting, the Management Representative is assigned the role of scribe to record notes about the discussions.
6
Top management shall ensure that quality objectives, including thoseneeded to meet requirements for product, are established for all functions (i.e., departments) and all levels within the organization. The qualityobjectives shall be measurable and consistent with the quality policy. The status of quality objectives shall be reviewed during management reviews and when one objective is met, Top Management shall determine if the objective shall be
If this manual is printed, it is an UNCONTROLLED
copy.
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