MANAGEMENT REVIEWS FOR
LABORATORIES
Introduction
By means of Management
Reviews an organisation may develop its quality system and its entire
organisation.
Aims of management
reviews
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;
- 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.
References
[1]
ISO/IEC 17025:2017, “General requirements for the competence of testing and
calibration laboratories”
