Kaji Ulang Manajemen ISO/IEC 17025:2017


By means of Management Reviews an organisation may develop its quality system and its entire organisation.

Management reviews will help an organisation to develop and improve its quality system and are an additional tool for the sound management of its organisation.
Therefore, it is necessary to look at all different processes of the organisation and changes caused by internal and external influences.

Quality policies and objectives should be evaluated and if necessary amended. Objectives and means to achieve them should be clearly formulated.

Organisation of management reviews
The purpose of management reviews is to evaluate and enhance the overall performance of an organisation. It is a major task of the top managers and of other staff involved in decision-making processes. This is the only way to guarantee that the aims and objectives outlined can be implemented at the operational level.
Whoever organises the management review, final responsibility and ultimate decisions must, however, rest with the top management.

Preparation of management reviews
Management reviews should be organised at planed intervals. It is helpful to convene a special meeting for preparing the management review. The number of participants depends on the size of the organisation. In bigger companies, a special meeting should be organised in the management circle. In smaller companies, the entire staff may be involved. The minimum is, however, a meeting between the manager and the quality manager.

Operation of management reviews
In preparation of the meeting it is helpful to prepare an agenda containing the following should or shall items (Requirement 8.9.2 of ISO/IEC 17025:2017 [1]):
Beyond compliance, management review should focus on the issues and the risks and opportunities.

- questions of prior management reviews;
- status of actions from previous management reviews
- fulfilment of objectives;
- medium and long term aims of quality policy;
- changes in internal and external issues that are relevant to the laboratory;
- changes in the volume and type of the work or in the range of laboratory activities, plans for the future including cost estimations, staff development and new equipment needed;
- results of risk identification;
- suitability of policies and procedures;
- reports from managerial and supervisory personnel and personnel feedback;
- outcome of recent internal audits;
- assessments by external bodies;
- effectiveness of any implemented improvements;
- analysis of corrective actions;

- outcomes of the assurance of the validity of results such as trend analysis of the results of interlaboratory comparisons or proficiency tests, trend analysis of the results of actions for monitoring the validity of results;
- adequacy of resources (personnel and equipment);
- trend analysis of complaints and other feedback from customers;
- appraisal of relevant suppliers;
- other relevant factors, such as monitoring activities and training.

(The bold parts are requirements of the standard ISO/IEC 17025:2017.)

Medium and long-term aims should be clearly identified to enhance the quality management system. If some objectives cannot be realised within the envisaged time schedule, reasons must be analysed and alternative objectives be defined. Persons responsible and deadlines should of course be also identified.

Results and records of management reviews
Records should be kept from all parts of the management-review process. They could include minutes of the meetings together with the action plan, the responsible persons and the time frames of the implementations.
They shall include all decisions and actions related to at least: (see 8.9.3 of ISO/IEC 17025:2017)

a) the effectiveness of the management system and its processes;
b) improvement of the laboratory activities related to the fulfilment of the requirements of this document;
c) provision of required resources;
d) any need for change.

It is important that all staff is informed about the results of management reviews, the conclusions and new aims.
The records should be archived.

[1] ISO/IEC 17025:2017, “General requirements for the competence of testing and calibration laboratories”