The Importance of word “Effectiveness” in Quality Management System
The word “Effectiveness” in ISO 17025:2017 and in ISO 9001:2015 has been use throughout the standard, many times, so this word has some exclusive meaning and requirement.
It is interesting to see word “Effectiveness” clause wise in both standards.
Here, to understand the importance of word Effectiveness, we will take first journey of standard ISO 17025:2017 clause by clause.
Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving improved results and preventing negative effects. The laboratory is responsible for deciding which risks and opportunities need to be addressed.
The use of this document will facilitate cooperation between laboratories and other bodies, and assist.
B. 5.5 e ensuring the effectiveness of laboratory activities
C. 5.7 Laboratory management shall ensure that:
a) Communication takes place regarding the effectiveness of the management system and the importance of meeting customers’ and other requirements;
D. 8.2.3 Laboratory management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness.
E. 8.5.2 The laboratory shall plan:
b) how to:
— integrate and implement these actions into its management system;
— evaluate the effectiveness of these actions.
F. 8.7.1 When a nonconformity occurs, the laboratory shall:
d) review the effectiveness of any corrective action taken;
G. 8.9.1 The laboratory management shall review its management system at planned intervals, in order to ensure its continuing suitability, adequacy and effectiveness, including the stated policies and objectives related to the fulfillment of this document.
H. 8.9.2 The inputs to management review shall be recorded and shall include information related to the following:
k) Effectiveness of any implemented improvements;
I. 8.9.3 The outputs from the management review shall record all decisions and actions related to at least:
a) The effectiveness of the management system and its processes;
Similarly, we will see the use of word effectiveness in ISO 9001:2015 and is as below:
A. 0.3.1 General
This international standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.
B. 0.3.1 General
Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results.
C. 0.3.3 Risk Base Thinking
Risk base thinking is essential for achieving an effective quality management system.
D. 7.1.5 General
d) Documented information determined by the organization as being necessary for the effectiveness of the quality management system.
E. 8.4.2 Type and extent of control
C2) The effectiveness of the controls applied by the external provider.
F. 9.1.1 General
The organization shall evaluate the performance and the effectiveness of the quality management system.
G. 9.1.3 Analysis and evaluation
e)The effectiveness of the action taken to address risk and opportunity.
H. 8.9.1 General
The top management shall review the organization’s quality management system at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment, with the strategic direction of the organization.
I. 9.3.2 Management review inputs
c) Information on the performance and effectiveness of the quality management system,
e) The effectiveness of the action taken to address risk and opportunity.
J. 10.1 General
c) improving the performance and effectiveness of the quality management system
d) review the effectiveness of any corrective action taken
L. 10.3 Continual improvement
The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.
So, what is effectiveness?
- The degree to which something is successful in producing a desired result; success.
- The degree to which objectives are achieved and the extent
to which targeted problems are solved. In contrast to efficiency, effectiveness
is determined without reference to costs and, whereas efficiency means
“doing the thing right,” effectiveness means “doing the right
From the above gathered information and collected number of times word EFFECTIVNESS came in both standard clause wise, we can easily judge the importance of word EFFECTIVNESS for quality management system.
Effectiveness of Quality Management System can be evaluated by monitoring the KPI, Key Performance indicators or objectives which are in line with policies, quality policy. When KPIs are in line with quality policy, means these KPI or objectives has some purpose for organization.
Consider, organization has KPI of zero customer complaint, this is nothing but expectation from the process, and so, here purpose is customer satisfaction. Ultimately effectiveness of process output to be evaluated.
This can be done through the collection of data related to particular KPI or objective and analyse the same and evaluate by comparing the trends from historical data.
Such evaluation also gives the space for identifying the opportunity and improvement, in other words this help to evaluate the risk and opportunity.