In ISO 17025, how do You Conduct and Document a Management Review?

After incorporating ISO/IEC 17025:2017 into its management system, a testing or calibration laboratory enters the maintenance and monitoring phase. This is not a quiescent phase of operation, but rather a dynamic phase in which processes are monitored and trends are analysed. It is now time to review the system during this "live" operational phase.

This article will help you comprehend what management review (MR) is, as well as its significance and usefulness. It will provide some practical recommendations on how to conduct the management review and format your ISO/IEC 17025 documentation to satisfy the standards of ISO 17025:2017 clause 8.9.

What do you Mean by Management Review in ISO/ IEC 17025?

A management review is not an audit or a report-back meeting. It is not about reporting metrics, but about determining how well the management system performs its functions and achieves its objectives. A management review is an opportunity for strategic planning. The goal of a management review is for top management and personnel involved in decision-making processes to evaluate the overall performance of the laboratory and its Quality Management System in a methodically.

In ISO/IEC 17025, how do you Conduct and Document a Management Review?

Because the ISO/IEC 17025 management review's quality purpose is the careful examination and evaluation of the management system, a well-designed Management Review Record should be utilised as the activity's core document. It can be used for planning, documenting inputs, and tracking the progress of agreed-upon actions. Because documents such as an agenda or minutes are not required, the Review Record can serve both functions.

The record is used to keep track of the following:

ISO/IEC 17025:2017 requires the following input review items:

1. Status of past management reviews' actions;

• The results of recent internal audits and external body reviews;
• Changes in internal and external challenges affecting the laboratory;
• Alterations in the amount and nature of work, or the scope of laboratory activities;
• Guarantee of the results' veracity;
• The outcomes of risk identification;
• Remedial measures
• Customer and employee feedback, complaints
• Other essential elements, such as activity monitoring and ISO/ IEC 17025 training
• Policies and procedures, as well as achievement of goals
• Incorporated enhancements; and
• Resources.

1. The process owner is the individual in charge of supplying data and information for review and carrying out agreed-upon actions. All people must understand their position, including what is expected of them and when. To contribute to the review meeting, process owners and department managers must understand what type of input and feedback is expected of them.
2. The review material required: for example, the most recent risk procedure, risk register, and pie chart illustrating a percentage breakdown of risk levels (low, medium, and high). To provide insight into trends, data and summaries of detectable trends should be provided graphically. PowerPoint presentations can be used to present reports as well as dashboards containing graphs and charts.
3. The outcome record of decisions and activities, which includes:

• Notes on how well the management review parameters (suitability, sufficiency, effectiveness, and efficiency of the input item) are met
• Any suggestions for improvement in terms of meeting the requirements
• Any provision of necessary resources
• Is there a need for change?

Ensure that the management review is a success.

All personnel must be informed about the outcomes of management reviews, the conclusions, and new quality goals. Information and communication can also take place via email as long as personnel have access to the most recent management review record and follow-up is ongoing and engaged through discussions and meetings.

Following are some pointers for good follow-up, monitoring, and closure actions:

• Ensure that personnel have the necessary degree of assistance, time, and resources to carry out actions properly.
• Encourage communication about any difficulties.
• Encourage recommendations and continuous feedback during quality meetings.
• Integrate the procedure and include follow-up in the audit program.

Michel Adrien has published so many articles regarding ISO Certification Documentation. As ISO Consultant profession since last many years Michel has rich experience in preparing such certification documents within ISO guideline to his global clients