ISO 9001:2015 Clause 9.1.3, titled "Analysis and Evaluation," specifies the requirements for organizations to analyze and evaluate data and information to ensure the effectiveness of their Quality Management System (QMS). This clause is integral to the continual improvement process within the QMS framework. It ensures that decisions based on this analysis and evaluation are made on factual information, thereby enhancing the organization's ability to meet customer requirements and improve customer satisfaction. Here's a detailed breakdown of its key components:
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Purpose and Scope: Clause 9.1.3 emphasizes the need for organizations to conduct a thorough analysis and evaluation of various data sources within the QMS. This includes data generated from monitoring and measurement activities, as well as other relevant sources.
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Data Sources: The clause identifies several key areas from which data should be collected for analysis. These areas typically include customer satisfaction, conformity to product and service requirements, the performance and effectiveness of processes within the QMS, the performance of external providers, and the degree to which quality objectives have been met.
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Analysis Objectives: The primary objective of this analysis is to provide a sound basis for making informed decisions regarding the QMS. This includes identifying areas for improvement, evaluating the need for changes to the QMS, and assessing the effectiveness of actions taken to address risks and opportunities.
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Evaluation Criteria: Organizations are encouraged to establish criteria for the evaluation of data and information. This ensures that the analysis is aligned with the organization's strategic direction and quality objectives.
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Decision Making: The insights gained from the analysis and evaluation process should be used to make decisions regarding process improvements, resource allocation, and other strategic decisions that can impact the organization's ability to meet customer expectations and regulatory requirements.
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Continual Improvement: By analyzing and evaluating data, organizations can identify trends, potential areas of nonconformity, and opportunities for improvement. This supports the principle of continual improvement, which is central to the ISO 9001 standard.
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Documentation: Organizations are required to maintain documented information as evidence of their analysis and evaluation activities. This documentation supports the traceability of decisions made and actions taken based on the analysis of data.
In summary, Clause 9.1.3 ensures that organizations have a systematic approach to analyzing and evaluating data from various sources within the QMS. This approach supports informed decision-making, contributes to the continual improvement of the QMS, and enhances the organization's ability to meet customer requirements and improve customer satisfaction.