Just as every organization undertakes an annual ritual of financial review, forecasting, planning and budgeting, a similar approach is specified in the ISO 9001:2000 standard for quality management. In the ISO 9001 standard, this process is referred to as a Management Review. Typically, such reviews are held as regularly scheduled events within an organization, with top management convening to review the performance of its quality management system against organizational goals and objectives, and other criteria as specified within the standard.
Specifically, as stated within the ISO 9001 standard, the purpose of a management review is to review the Quality Management System to ensure its continuing adequacy, suitability and effectiveness. This should include an evaluation of the performance of the system based on existing data (review inputs), and should also address any decisions or actions necessary to improve the program and its related processes (review outputs).
To further define the concepts of adequacy, suitability and effectiveness:
Adequacy – Sufficient to satisfy a requirement or meet a need*. A quality management system should be capable of satisfying applicable requirements including those specified by the organization, the customer, and any applicable standards and/or regulations.
Suitability – The quality of having properties that are right for the specific purpose*. A quality management system should be able to sustain the current performance levels of the organization utilizing an acceptable amount of organizational resources.
Effectiveness – Adequate to accomplish a purpose; producing the intended or expected result*. A quality management system should enable the organization to meet its own needs, those of the customer and those of other interested parties.
As a minimum, such reviews should be performed annually, although they may be performed on a more frequent basis, including quarterly or even monthly. I personally recommend that oganizations with “newer" systems perform this function on a more frequent basis, at least for the first 18-24 months.
Records of these reviews should be maintained in accordance with documented record control procedures. These records should include, as a minimum, the date of the review, participants in the review, criteria by which the system is measured, strengths and weaknesses of the system, and any decisions or actions that are required.
To assist the organization that is new to this process, I’ve attached the following management review template below. These topics should be considered as the “bare minimum" necessary, and this template should be further modified or expanded, as necessary, to address any additional issues or considerations that the organization may have.
Sample Management Review Agenda
1. ASSESSMENT OF QMS PERFORMANCE
1.1. Management System
1.2. QMS Policy
1.3. QMS Objectives and Targets
2. REVIEW INPUTS
2.1. Results of Audits
2.2. Communication from External Parties, Including Complaints
2.3. Process Performance / Conformance
2.4. Status of Preventive and Corrective Actions
2.5. Follow-up actions from Earlier Management Reviews
2.6. Personnel Status
2.7. Changes That Could Affect this Management System
3. REVIEW OUTPUTS
3.1. Opportunities for Improvement of this Management System:
Disclaimer: All information on this site is provided for informational purposes only! By no means is any
information presented herein intended to substitute for the advice provided to you by any health care or other professional
or organization.
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