Understand The Necessary Of The Iso/iec 17025 Management Review

By Author: John
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ISO/IEC 17025 defines specific requirements for testing and calibration competence, including sampling. It covers quality system testing and calibration using standard methods as well as laboratory-developed or modified methods. The standard includes requirements for general, structural, resource, process, and management systems. The requirements for the general, structural, and management systems are primarily concerned with the operation and effectiveness of the laboratory's quality management system and the laboratory organization itself. The resource and process requirements include factors that determine the correctness and reliability of the laboratory's tests and calibrations.

An audit or report-back meeting is not the same as a management review. It is not about reporting metrics, but it's about determining how well the management system performs its functions and accomplishes its goals. Strategic planning is a reasonable chance during a management review. The aim of a management review is mostly for top management and persons involved in decision-making processes to assess the overall performance of the laboratory ...
... and its Quality Management System in a systematic manner.

Why is it necessary to conduct management reviews?
Organizations as well as interested parties (including the accreditation body) must be convinced of the laboratory's management system's ongoing suitability, adequacy, and effectiveness, as well as its defined policies and goals. When weaknesses are acknowledged through management review, plans can be developed for necessary changes and resources. To make the best use of available resources, efficiency should be reviewed. As a result, four key parameters are taken into consideration during management review in ISO/IEC 17025:

• Suitability: Are suitable procedures and operations that can be used to enable/support laboratory activities?
• Adequacy: Check to see if all of the ISO 17025 contractual, organizational, and regulatory requirements have been met.
• Effectiveness: Examine the extent to which the management system is capable of achieving the goal of creating the desired or expected result.
• Efficiency. Analyze the relationship between the resources used and the results attained to determine the best use of those resources.

How should a management review be conducted and documented using ISO 17025?

Even though the ISO 17025 management review's quality target is the careful examination and evaluation of the management system, a well-designed Management Review Record should be utilized as the activity's core document. It can be used for planning, documenting inputs, and tracking the progress of agreed-upon actions. Although ISO/IEC 17025 documents such as an objective or reports are not required, Also the Review Record can serve both functions. Here are some of the records used to document the following:

1. The mandatory input review items of ISO/IEC 17025:2017, are:
o status of activities from previous management reviews
o outcome of recent internal audits and assessments by external bodies
o changes in internal and external matters that are relevant to the laboratory
o changes in the capacity and type of the work or the range of laboratory activities
o assurance of the validity of results
o outcomes of risk identification
o corrective actions
o complaints, customer and personnel feedback
o other relevant factors, such as monitoring activities and training;
o policies and procedures and fulfillment of aims
o implemented improvements and resources.

2. The process owner: The individual responsible for supplying data and information for analysis and carrying out decided-upon actions. All employees must be informed of their responsibilities, including what is expected of them and by when. To participate in the review meeting, process owners and department managers must be aware of the type of input and comments needed from them.

3. The review material required: the most recent risk policy, risk register, and pie chart showing the percentage split of risk levels, for instance (low, medium, high). To shed light on patterns, data and summaries of discernible trends should be presented visually. Dashboards with graphs and charts can be used in PowerPoint presentations, as well as reports.

4. The output record of decisions and actions, including:
o Notes on the extent to which the management review parameters are met
o Any improvement notes related to the fulfillment of the requirements
o Any establishment of required resources
o Any requirement for change