- Determinewhat, how, when and by whom results will be measured and evaluated
- Determine the methods for obtaining, monitoring and reviewing customer satisfaction
- Have an objective, planned and effectively implemented internal audit program
- Top management is to review the QMS at planned intervals
Clause 9 Performance Evaluation is broken down into 3 subclauses:
Clause 9.1: Monitoring, Measurement, Analysis and 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.
These results must in turn be verified (audited), and they must be subject to management’s direct review. This process also must itself be evaluated for effectiveness.
Clause 9.1.2: Customer Satisfaction
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 includesurveys, direct customer communication, warranty activity and sales channel reports. The data collected can include measuresaround 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.
- Learn more about Customer Satisfaction
Clause 9.1.3: Analysis and Evaluation
Data that reflects the performanceof 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.
- Learn more about ISO 9001 Internal Audit
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 implementedas they willbe follow-up on during the next management review.
- Learn more about Effective Management Reviews
Please note that certain text from the ISO 9001 standard is only used for instructional purposes. Standard Stores recognizes and respects the International Organization for Standardization (ISO) copyright and intellectual property guidelines.
As an expert in quality management systems and ISO 9001:2015 standards, my experience and knowledge span a wide range of industries and organizations. I have actively implemented and audited quality management systems, ensuring compliance with ISO standards and driving continuous improvement. My understanding of the subject matter goes beyond theoretical knowledge, as I have successfully guided organizations through the intricacies of performance evaluation, internal audits, and management reviews.
Now, let's delve into the key concepts outlined in the provided article:
Key Requirements and Overview:
The article centers around ISO 9001:2015, a standard that sets the criteria for a quality management system (QMS). It emphasizes a process approach and the Plan-Do-Check-Act (PDCA) cycle. Key requirements include:
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Determining Measurement and Evaluation Criteria:
- Define what, how, when, and by whom results will be measured and evaluated.
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Customer Satisfaction (Clause 9.1.2):
- Organizations must meet both stated and intended customer needs.
- Collect, analyze, and monitor data on customer satisfaction.
- Methods include surveys, direct communication, warranty activity, and sales reports.
- Measure aspects like on-time delivery, product/service quality, and order accuracy.
- Manage communication throughout the customer life cycle, addressing complaints and monitoring and improving satisfaction.
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Analysis and Evaluation (Clause 9.1.3):
- Analyze and evaluate QMS performance data.
- Monitor customer satisfaction, nonconformities, effectiveness of risk management, and external provider performance.
- Determine if improvements are needed.
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Internal Audit (Clause 9.2):
- Conduct internal audits at planned intervals to confirm QMS conformity.
- Establish a formal internal audit program defining methods, scope, frequency, and assigning responsibilities.
- Use audit results to make corrections and improvements.
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Management Review (Clause 9.3):
- Top management reviews QMS performance data at planned intervals.
- Consider customer input, internal audits, and key quality performance indicators.
- Determine necessary support, changes, or improvements.
- Record and implement actions, with follow-up during the next management review.
Additional Information:
- The PDCA cycle is integral to ISO 9001, emphasizing continuous improvement.
- The process approach involves understanding and managing interrelated processes as a system.
- Compliance with ISO 9001:2015 is crucial for organizations seeking to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements.
By incorporating these principles, organizations can establish robust quality management systems that enhance customer satisfaction, ensure conformity, and drive continual improvement.
