Management Review

ISO 13485 is probably one of the key quality system regulation for medical device sponsors to comply with. ISO 13485 shares many similarities with US FDA 21 CFR 820. Management review is the focus for this blog.

1.     Frequency and Scheduling

Executive management should review the quality performance and quality management of the whole organization at least once a year. Specific dates like June and December should be stated if the management review decided to review twice a year. Executive management when responding to changing and special conditions and events like consent decree and warning letter can call for any unscheduled and extraordinary reviews. Nothing is carved in stone.

 2.     Attendance

Management reviews should be chaired by top executive like CEO and attended by managers representing Quality Assurance, Marketing and Sales, Design Engineering, Regulatory Affairs, Manufacturing, Quality Control, Purchasing and Human Resources. Managers who cannot be present can send representative and he or she after receiving the meeting minutes, may submit their input and comments to the CEO and/or quality assurance.

 3.     Agenda

QA should setup the agenda for management review a week or more prior to the meeting and distributed to all participating managers. This will give respective managers some time to prepare for the meeting and raise some quality issue during the management review.

 4.     Management Review Input

The following are some of the quality issues which can be discussed in the quality review: action Items from last meeting, process performance and product conformity, internal quality audits, external quality audits, corrective and preventive action (CAPA), post-production feedback, customer complaints, product recall, customer recall, training, continual improvement, new or revised regulatory requirements and its ramification, medical device reporting (MDR), safety and effectiveness, application status and any changes that could affect the company’s quality system.

 5.     Quality Policy and Quality Objectives

Quality policy and quality objectives are two keys issues to be discussed during management review. During management review, the progress of quality policy and quality objectives must be discussed.  Quality objectives must be systematically evaluated to access the progress during management review. If the quality objective of certain issue is closed, the resource can be moved to deal with another quality objective.

 If any quality objective is not achieved on time, the review can investigate and determine the causes of the failure to achieve the deadline. Management can decide what to do with the failed quality objective. They can drop the objective, reduce the scope, reassign responsibility, allocate additional resources or extend the deadline.

 During the management review, new objectives are established when necessary to improve quality performance during the management review. These new objectives should be documented in the Quality Objective Record.

 The quality policy of the organization shall be discussed to access its suitability to the whole organization amidst of new regulatory, addition of new product, product changes and the like. For example, if a medical device company begins to manufacture Class III device, its quality policy and quality system may need to be updated.

 6.     Management Review Output

Resources needed for the implementations of the improvements are identified as review output. This includes the assignment of responsibility, timeframe, and allocation of human like more personnel and the employment of consultants, equipment and know-how. Management review output is documented in review meeting’s minutes. Action items are highlighted.

7.     Record

Management review output during the meeting should be prepared by Quality Assurance and distributed to the attending managers and absent managers as well. All the management review record shall be stored in a known location both virtually and hard-copy. These record can only be disposed according to the timeframe stated in control of record’s policy.

Reference	Criteria
ISO 13485 5.5.2.a	Has top management appointed a member of the management who, irrespective of other responsibilities, has responsibility and authority that includes ensuring that processes needed for the quality management system are established, implemented and maintained?
ISO 13485 5.5.2.b	Has top management appointed a member of the management who, irrespective of other responsibilities, has responsibility and authority that includes reporting to top management on the performance of the quality management system and any need for improvement?
ISO 13485 5.5.2.c	Has top management appointed a member of the management who, irrespective of other responsibilities, has responsibility and authority that includes ensuring the promotion of awareness of regulatory and customer requirements throughout the organization?
ISO 13485 5.5.3	Has top management ensured that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system?
ISO 13485 5.6.1	Has top management reviewed the company's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness? Does the review include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives?  Does the company maintain records from these management reviews?
ISO 13485 5.6.2 a	Does the input to management review include information on the results of audits?
ISO 13485  5.6.2 b	Does the input to management review include information on customer feedback?
ISO 13485  5.6.2 c	Does the input to management review include information on process performance and product conformity?
ISO 13485 5.6.2 d	Does the input to management review include information on status of preventive and corrective actions?
ISO 13485 5.6.2 e	Does the input to management review include information on follow-up actions from previous management reviews?
ISO 13485  5.6.2 f	Does the input to management review shall include information on changes that could affect the quality management system?
ISO 13485  5.6.2 g	Does the input to management review shall include information on recommendations for improvement?
ISO 13485 5.6.2 h	Does the input to management review include information on new or revised regulatory requirements?
ISO 13485  5.6.3 a	Does the output from the management review include any decisions and actions related to improvements needed to maintain the effectiveness of the quality management system and its processes? Does the output from the management review include any decisions and actions related to improvement of the effectiveness of the quality management system and its processes.
ISO 13485  5.6.3 b	Does the output from the management review include any decisions and actions related to improvement of the product related to customer requirements?
ISO 13485  5.6.3 c	Does the output from the management review include any decisions and actions related to resource needs?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.