Management Review. ISO 9001:2015 Clause 9.3
The nine
clause of ISO 9001 ends with the requirement for top management to review the
quality management system of the company at planned dated in order to ensure it
is suitable, adequate, and effective.
Management
does not have to define the operation controls but must know what is going on
in the quality management system, are the employee’s performance their duties,
if the quality management system is achieving desired results, etc.
Based on
that the management must take some crucial decisions. The standard requires top
management to review the following aspects:
1- The condition of actions from previous management review.
For
example, if the last management review a decision was made to train 3 more
internal auditors in order to be able to conduct more internal audits with out
the year, the management should check if this action was implemented and what
is their results.
2- Changes in external and internal issues relevant to the quality management system.
For
example, some external issues have not been addressed such as market trends.
3- Changes in needs and expectations of interested parties.
For example, your client might change requirements regarding one of your products, but the same requirements should be met with other products.
4- Performance of external providers.
Meaning to
analysis whether the suppliers deliver what is expected from them and is there
a need for additional control of the suppliers.
5- Effectiveness of action taken to address risk and opportunities.
For
example, is the level of risk decreased or a level of opportunities increased.
6- Level of achievement of the quality objectives.
When the
objectives are met, the management should introduce new ones. But if the
objectives have not been met, the management must imitate corrective actions to
determine the root cause and to ensure the objective will be met in the future.
7- Information on process performance.
Including
nonconformities, corrective actions, monitoring and measurements results,
conformity of products and services, audit results and, adequacy of resources.
8- Opportunities for improvement of QMS.
Based on
all decisions, management should identify opportunities for improvement of QMS.
For example, based on customer feedback, the company may decide to improve
customer support process.
The best
practices show that usually this review of the QMS is conducted through a
meeting where all the pervious mentioned aspects are discussed and analysed.
Based on the results of analysis, decisions are taken related to continuo
improvement opportunities and the need changes of QMS.
Such
meeting should be held at least once a year or more often. The ISO 9001
requires the company documented the result from the management review as
evidence, usually after the meeting, the outputs are documented in management
review meeting minutes or in a report.
- Mandatory outputs of the management review include:
1- Opportunities for improvement.
For
example, you can raise a bar for some project objectives that already achieved,
and this will make you to create some new plans for achieving them and this
will lead to improvement.
2- Decisions related to the changes of the quality management system.
For
example, the company decide to outsource some processes and establish the new
controls for outsource processes.
3- Resources needs.
For
example, during analysis of quality objectives achievement, the management may
conclude some objectives have not been met because the lake of resources and in
the new plans for achieving objectives, additional resources will be appointed.