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h the effectiveness and efficiency of communicating with interested parties should be measured to determine whether the information is timely and clearly understood;
i where process and product performance criteria are met, it may still be beneficial to monitor and analyse
performance data in order to understand better the nature of the characteristic under study; j
the use of appropriate statistical or other techniques can help in the understanding of both process and measurement variation, and can thereby improve process and product performance by controlling variation;
k self-assessment should be considered on a periodic basis to assess the maturity of the quality management system and the level of the organizations performance, as well as to define opportunities for performance
improvement see annex A.
8.2 Measurement and monitoring
8.2.1 Measurement and monitoring of system performance 8.2.1.1 General
Top management should ensure that effective and efficient methods are used to identify areas for improvement of the quality management system performance. Examples of methods include
— satisfaction surveys for customers and other interested parties, — internal audits,
— financial measurements, and — self-assessment.
8.2.1.2 Measurement and monitoring of customer satisfaction
Measurement and monitoring of customer satisfaction is based on review of customer-related information. The collection of such information may be active or passive. Management should recognize that there are many sources
of customer-related information, and should establish effective and efficient processes to collect, analyse and use this information for improving the performance of the organization. The organization should identify sources of
customer and end-user information, available in written and verbal forms, from internal and external sources. Examples of customer-related information include
— customer and user surveys, — feedback on aspects of product,
— customer requirements and contract information, — market needs,
ISO 9001:2000, Quality management systems — Requirements
8 Measurement, analysis and improvement
8.1 General
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
a to demonstrate conformity of the product, b to ensure conformity of the quality management system, and
c to continually improve the effectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
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© ISO 2000 – All rights reserved
— service delivery data, and — information relating to competition.
Management should use measurement of customer satisfaction as a vital tool. The organizations process for requesting, measuring and monitoring feedback of customer satisfaction should provide information on a continual
basis. This process should consider conformity to requirements, meeting needs and expectations of customers, as well as the price and delivery of product.
The organization should establish and use sources of customer satisfaction information and should cooperate with its customers in order to anticipate future needs. The organization should plan and establish processes to listen
effectively and efficiently to the “voice of the customer”. Planning for these processes should define and implement data-collection methods, including information sources, frequency of collection, and data-analysis review. Examples
of sources of information on customer satisfaction include
— customer complaints, — communicating directly with customers,
— questionnaires and surveys, — subcontracted collection and analysis of data,
— focus groups, — reports from consumer organizations,
— reports in various media, and — sector and industry studies.
8.2.1.3 Internal audit
Top management should ensure the establishment of an effective and efficient internal audit process to assess the strengths and weaknesses of the quality management system. The internal audit process acts as a management tool
for independent assessment of any designated process or activity. The internal audit process provides an independent tool for use in obtaining objective evidence that the existing requirements have been met, since the
internal audit evaluates the effectiveness and efficiency of the organization.
It is important that management ensure improvement actions are taken in response to internal audit results. Planning for internal audits should be flexible in order to permit changes in emphasis based on findings and objective evidence
obtained during the audit. Relevant input from the area to be audited, as well as from other interested parties, should be considered in the development of internal audit plans.
Examples of subjects for consideration by internal auditing include — effective and efficient implementation of processes,
— opportunities for continual improvement, — capability of processes,
— effective and efficient use of statistical techniques, — use of information technology,
ISO 9001:2000, Quality management systems — Requirements
8.2 Monitoring and measurement
