Discover What is Management Reviews and Its Importance in ISO/IEC 17025

Management reviews are vital processes in several quality-management systems, as well as laboratory-management systems, in compliance with ISO/IEC 17025. Management reviews are excellent opportunities to understand and manage all of the inputs and outputs of a quality management system. Laboratories commonly experience difficulties fully utilizing the management-review process because they either do not recognize the importance of that kind of process or may not have the experience to run this process in a way that produces the desired results.

Once the testing or calibration laboratory has executed ISO/IEC 17025 as part of its management system, it needs to enter the maintenance and monitoring stage. It isn't an undiscovered phase of operation, but it is an interactive phase in which procedures are monitored and developments are examined. It is time to re-evaluate the system throughout this real-time operational phase.

What is the management review in ISO 17025?

A management review is not an audit or a summary meeting. It does not consist of reporting metrics, but of assessing how well the management system performs its functions and accomplishes its objectives. A management review is a chance for strategic planning. The goal of a management review is for top management and personnel who participate in decision-making processes to assess the entire performance of the laboratory and its Quality Management System in a systematic manner.

Why is it important to perform management reviews?

Organizations and decision makers (including the accreditation body) must be trusted with the laboratory's management system's continuous suitability, efficacy, and effectiveness, as well as its stated policies and objectives. When weaknesses are identified through management review, plans can be developed for required changes and resources. To make the best use of available resources, efficiency should be assessed. As a result, four key parameters are taken into account during management review in ISO/IEC 17025:

Suitability: Are the proper procedures and processes used to help and support the laboratory's activities? Keep the ISO/IEC 17025 documents accessible and also for later reference.

Adequacy: Examine to see if all of the contractual, organizational, and statutory objectives of ISO 17025 have been met.

Effectiveness: Analyze the measure within which the management system can achieve its goal of generating the desired or anticipated result.

Efficiency. Determine the most effective use of resources by examining the connection between the outcomes attained and the resources utilized.

What does a management review require?

The ISO 17025 standard does, however, define a few inputs and outputs that are required for the management review. Here, provided some consideration remarks:

Firstly changes in relevant internal and external issues, fulfillment of objectives, suitability of policies and procedures, the status of actions from previous management reviews, outcomes of recent internal audits, corrective actions, assessments by external bodies, changes in the volume or in the range of laboratory activities, customer and personnel feedback, complaints, the effectiveness of any implemented improvement, adequacy of resources, results of risk identification, outcomes of the assurance of the validity of results, other relevant factors, and monitoring activities and training.

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Iso 13485:2016 Medical Devices Quality Management System