Evaluating the ISO 9001:2015 Quality Management System’s Performance
Section 9 Performance Evaluation
As noted elsewhere, the standard emphasizes both a process approach, and the need to utilize a review or checking phase (from the Plan>Do>Check>Act approach.) The standard mandates determining what data needs to be collected, how that data is collected and interpreted, and what results should be acted upon from a variety of inputs at various points in the quality management process.
ISO 9001:2015 standard states that organizations are required to meet both stated and intended needs of their customers. Data on the degree of customer satisfaction needs to be collected, analyzed and monitored to ensure customer expectations are being met. Data collection methods include surveys, direct customer communication, warranty activity and sales channel reports. The data collected can include measures around on time delivery, product/service quality, or order accuracy. The standard also wants the organization to identify and manage communication during the entire customer life cycle; this includes: how complaints will be addressed and solved and how customer perception and satisfaction will be monitored and improved.
Section 9.1.3: Analysis and Evaluation
Data that reflects the performance of the QMS must be analyzed and evaluated to determine if improvements need to be made. Examples of data to monitor and measure include customer satisfaction, nonconformities, effectiveness of risk management and external provider performance.
In order to confirm that the QMS conforms to the ISO 9001:2015 standard and the organization’s standards internal audits must be conducted at planned intervals. A formal internal audit program needs to be established which defines the methods used, scope and frequency as well as assigning responsibility to objective and impartial auditors. The results of internal audits are used to make corrections and improvements to the QMS.
Data collected on QMS performance (i.e. customer input, internal audits, key quality performance indicators) and determination of any support, changes, or improvements must be reviewed and discussed by top management at planned intervals. Actions generated from the review must be recorded and implemented as they will be follow-up on during the next management review.
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