ISO 9001:2015 Clause 9.1.3 focuses on the analysis and evaluation of data to assess the performance and effectiveness of the quality management system (QMS). This reinforces ISO 9001's emphasis on collecting and using data for fact-based decision-making.
ISO 9001:2015 Clause 9.1.3 - Analysis and Evaluation:
Determination of What to Analyze: The organization needs to identify what data needs to be analyzed. This could include various types of data, such as process performance data, product conformity data, customer satisfaction data, etc.
Methods for Analysis and Evaluation: The clause requires the organization to establish methods for the analysis and evaluation of this data. This involves defining the techniques and tools that will be used to make sense of the collected information.
Timing of Analysis and Evaluation: The organization is expected to determine when this analysis and evaluation will be performed. This timing could be linked to specific events, milestones, or periodic reviews, as appropriate for the organization's context.
Performance Evaluation of the QMS: The primary purpose is to evaluate the performance and effectiveness of the Quality Management System (QMS). This involves assessing how well the QMS is meeting its objectives, ensuring conformity, and delivering continual improvement.
Management Review Meetings: Analysis and evaluation play a crucial role in management review meetings. The results of these analyses are presented during these meetings, providing top management with the necessary information to make informed decisions about the QMS.
Documentation of Results: The organization is required to retain appropriate documented information as evidence of the results of the analysis and evaluation. This documentation serves as a record of the organization's commitment to monitoring and improving its processes.
Continuous Improvement: One of the main objectives of analysis and evaluation is to identify areas for improvement. This aligns with the broader principle of continual improvement, a core aspect of ISO 9001.
Clause 9.1.3 Example Manufacturing Company
Data Analyzed: They regularly analyze data on product defects, customer complaints, and internal audit results.
Methods: Statistical process control charts are used to monitor the variation in the manufacturing process.
Timing: Monthly reviews are conducted, and more in-depth analyses are performed during quarterly management review meetings.
Performance Evaluation: The organization assesses how well it's meeting product quality objectives and customer satisfaction goals.
Documentation: Results of these analyses are documented in reports that are then reviewed during management meetings and made available for audit purposes.
ISO 9001:2015 Clause 9.1.3 Analysis and Evaluation
Clause 9.1.3 analysis and evaluation ensures that the organization is proactive in assessing the effectiveness of its QMS, identifying areas for improvement, and making informed decisions based on data and analysis.