The ISO 9001 Standard expects the organization to define which inputs and sources of information in the QMS may indicate the need for improvement.
The standard refers to some well-known and widely used quality tools and their outputs:
• Quality policy
Deviation from the general guidelines, intentions, and goals referring to quality may suggest that an improvement is required.
• Quality objectives
The purpose of quality objectives is to carry out the quality policy and implement it in the QMS. These objectives are to be aimed, planned, and implanted for achieving improvement. Lack of obtainment of these objectives may suggest that an improvement is needed.
• Results of audits (internal or external)
Audit is an effective tool in identifying opportunities for improvements, since the outputs of the audit indicate whether a nonconformity (which is, by definition, a lack of achievement of objectives) or opportunity for improvement was detected.
• Monitoring, measurement, analysis, and evaluation activities
A quality activity that indicates the status of processes or process outputs with reference to their criteria may point out opportunities for improvements.
• Results of process audits
Process audit is a method that you may apply in order to measure and evaluate performance of processes, their ability to create a product according to its specifications and the extent to which process outputs meet their requirements.
Where the results indicate inability of processes, it may indicate the need for improvement.
• Non-Conformities
Nonconformity is an indication that the product has not met its specifications, suggesting a need for improvement.
• Addressing risks and opportunities
Improvements may be suggested while conducting activities to reduce or eliminate risks or promote opportunities.
• KPI
Key process indicators identify performance gaps and indicate areas for potential improvement.
• Customer feedback, warranty call, and complaints
These are activities that involve direct communication with the customer regarding the performance and characteristics of the product or service. These types of outputs are very effective for identifying opportunities for improvements.
• Corrective actions
There is a correlation between the improvement and the corrective actions, since each of these may be considered an improvement. Therefore, these actions may be presented as improvements. However, there are cases where corrections are temporary, and thus a long-term action of improvement is required.
• Management review
One of the outputs of the review is the suggestion for improvements and changes to the QMS and its processes.
• Employees
Another effective source for improvement is collecting ideas for improvement from personnel that operate the QMS. It is a very effective source because employees know the processes and the activities and face the daily problems.
A classic method is for employees to fill in a form, where they can describe their idea for improvement.
The next aspect to be considered is the information and data that those inputs provide.
In order to initiate improvements in the organization you have to make sure that relevant and accurate data and information flow to the appropriate persons:
• Information and details about the need for the improvements
• Data must be measurable, accurate and reliable, and usable to indicate need to improve process efficiency and effectiveness
• Data that will support the decision for the improvements
• Data that will enable monitoring of the effectiveness of the improvements
After collecting the inputs for the improvements, one must determine where the improvement shall be applied.