ISO 9001 has put an emphasis on the concept of continual improvement. In the most recent version, Clause 10.3 states “The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.” The organization must consider the results of evaluations and the outputs from management review to determine if there are needs or opportunities that should be addressed as part of continual improvement.
This needs to be driven by top management and should address the improvement of internal efficiency, individual customer needs, as well as the level of performance expected by the customers. Continual improvement is a recurring activity that is carried out in order to enhance performance. The rationale is that by improving the effectiveness and efficiency of your QMS, your company will directly and indirectly improve in others areas (such as product quality, competitiveness, employee relations, customer satisfaction, etc.) by default. This process is usually initiated by one of two methods:
- Significant breakthrough projects that revise/improve the existing processes or lead to new processes.
- Small-step ongoing improvement activities.
Areas that can lead to improvement activities include: audits, self-assessments, management review, collecting and analyzing data, setting objectives, and implementing corrective and preventive actions.