![Advisera Tracey Evans](https://advisera.com/wp-content/uploads/blog_authors/traceyevans.jpg)
May 3, 2021
Once a testing or calibration laboratory has implemented ISO/IEC 17025:2017 as part of its management system, it moves into a maintenance and monitoring phase. This is a not a dormant, but rather a dynamic phase of operation, where processes are monitored and trends are reviewed. During this “live” operational phase, it is time to review the system.
This article will help you gain a better understanding of what management review (MR) means, as well as its importance and value. It will provide some practical guidance on how to go about the management review and how to structure your documents to meet ISO 17025:2017 clause 8.9 requirements.
Management review is neither an audit nor a report-back discussion. It is not about reporting measurements, but evaluating to what extent the management system fulfills its functions and goals. Management review is a strategic planning opportunity. The purpose of a management review is for top management and personnel involved in the decision-making processes to systematically evaluate the overall performance of the laboratory and its Quality Management System.
To learn more about the maintenance of the ISO 17025 management system, read this: Maintaining and improving quality management in laboratories according to ISO 17025:2017.
Organizations and stakeholders (including the accreditation body) need to be assured of the continuing suitability, adequacy, and effectiveness of the laboratory’s management system, along with its stated policies and objectives. When shortcomings are identified through management review, provisions can be made for necessary changes and required resources.
Efficiency should also be evaluated to ensure best use of allocated resources. There are, therefore, four key parameters that are considered during management review in ISO/IEC 17025:
To clarify a misconception about management reviews, note that the review doesn’t have to be a singular annual meeting covering all requirements. The management review can be conducted over a number of meetings with previously written agendas, where partial inputs may even be evaluated via email or other collaborative platforms at different levels within the laboratory. Responsibility is usually assigned to the top laboratory manager, who will conduct a final review with the gathered information and contributions. This can be done in a review meeting.
To meet the intent of the review, typically, at least one review of the entire management system should be performed each year. The output of the review is to set goals and objectives for the forthcoming period, so it is good practice to align the review period with the organization’s financial year, parent company strategy sessions, and the laboratory’s accreditation assessments. It makes sense to complete the review in a timely manner for budget input. Processes or annual programs, such as auditing, should in turn be aligned to the MR period, meaning that the audit program should be completed before the MR meeting.
Since the quality goal of the ISO 17025 management review is the careful analysis and evaluation of the management system, a well-designed Management Review Record should be used as the core document of the activity. It can be used for planning, recording the inputs, and recording and monitoring progress of agreed actions. There is no mandatory requirement for documents such as an agenda or minutes, so the Review Record can be used for both purposes.
The record is used to document the following:
For example, for the input “Results of risk identification,” the outputs could be the following:
It is important that all personnel are informed about the results of management reviews, the conclusions, and new quality aims. The information and communication can even be via email, as long as personnel have access to the latest management review record, and follow-up is ongoing and engaging through discussions and meetings.
Some tips for effective follow-up, monitoring, and closing actions are:
A final tip: Do not forget to ask all involved personnel for feedback to evaluate the success of the completed management review process, as an input to improve the next one!
To learn more about the management review process and other requirements of ISO 17025, download this free white paper: Clause-by-clause explanation of ISO 17025:2017.