8 Measurement, analysis and improvement
8.1 General
The organization shall plan and carry out the monitoring, measurement, analysis and improvement processes needed:
a) to demonstrate conformity of products;
b) to ensure that the quality management system, as well as
c) to continually improve the quality management system.
This should include identification of suitable (applicable) methods, including statistical techniques, and the volume (area) of their use.
8.2 Monitoring and measurement
8.2.1 Customer Satisfaction
As one way of measuring how the quality management system, the organization shall monitor information relating to consumer perception as to whether the organization of his claim. Methods for obtaining and using this information should be set.
8.2.2 Internal Audit
The organization shall conduct internal audits at planned intervals to determine:
a) whether the quality management system to the planned arrangements (see 7.10, the international standard and requirements for quality management system established by the organization, as well as
b) Is effectively implemented Quality Management System supported and whether it is in working condition.
The audit program should be planned taking into account the status and importance of the processes and areas to be audited, as well as the results of previous audits. Must define the criteria for audit auditee area, frequency and methods of auditing. Auditors should not audit their own work.
Responsibilities and requirements for planning and conducting audits, reporting on their findings, as well as to maintain and preserve records on this subject (see 4.2.4) should be defined in a documented procedure.
Leadership responsible for the audited area of activity, must ensure that no undue delay action be taken to address identified gaps and their causes. Follow-up activities shall include verification of measures taken and the reporting of verification results (see 8.5.2).
Note. Guidance on this subject can be found in ISO 10011-1, ISO 10011-2 and ISO 10011-3 (now instead of the standard operating ISO 19011 : 2002 - approx. Trans.).
8.2.3 Monitoring and measurement of processes
The organization shall apply suitable methods for monitoring and, where applicable, measurement of quality management system processes.
GOST R ISO 9,001 -2,001: The organization shall apply suitable methods for monitoring and, where appropriate, measuring the quality management system processes.
ISO 9001:2000 (E): The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes.
These methods shall demonstrate the ability of processes to achieve planned results. In cases where the planned results are not achieved, should be a suitable way (way) to be implemented correction and corrective action to ensure product.
8.2.4 Monitoring and measurement of product
The organization shall monitor and measure product characteristics to verify that you have satisfied the requirements for the product. This should be done at appropriate stages of the process of creating products in accordance with planned arrangements (see 7.1).
Evidence of conformity with the acceptance criteria shall be recorded and maintained. These records shall indicate the person (s) authorizing (s) to output (see 4.2.4).
Product release and service delivery shall not proceed until such time until the planned arrangements (see 7.1) have been successfully completed, if not approved (authorized) other relevant authorized persons or bodies and, where applicable, the consumer.
8.3 Control of nonconforming product
The organization shall ensure that products which do not comply to it, was identified and was under control in order to prevent its inadvertent (unintentional, accidental) use or delivery. Management activities and related responsibilities and authorities as to what, how to deal with nonconforming product shall be defined in a documented procedure.
The organization shall deal with nonconforming product by one or more of the following ways:
a) taking steps to resolve the discrepancy
b) by authorizing its use, the transition to the next stage of acceptance or if you have permission to deviate from the relevant authorized persons or bodies and, where applicable, the consumer;
c) taking action to prevent its original intended use or application.
Shall be maintained a record of the nature of nonconformities and any subsequent actions taken, including concessions obtained (see 4.2.4).
Once the nonconforming product is corrected it shall be re-verification to demonstrate conformity.
When nonconforming product is detected after delivery or the beginning of its use, the organization shall take actions consistent with the consequences or potential consequences of non-compliance.
8.4 Analysis of data
The organization shall establish, collect and analyze appropriate data to demonstrate the suitability and effectiveness of quality management system to assess and, where it can be made constant improvement of the quality management system. These should include data from monitoring and measurement, as well as information from other relevant sources.
Data analysis should provide information regarding:
a) to customer satisfaction (see 8.2.1);
b) the conformity to product requirements (see 7.2.1);
c) characteristics and trends of processes and products including opportunities for preventive action, as well as
g) to suppliers.
8.5 Improvement
8.5.1 Continuous improvement
The organization shall continually improve the effectiveness of quality management system through the use of policy and quality objectives, audit results, analysis, corrective and preventive actions and management review.
8.5.2 Corrective Action
The organization shall take action to eliminate the cause of nonconformities in order to prevent their recurrence. Corrective action must comply with the consequences of identified discrepancies.
There should be a documented procedure established to define (install it) requirements:
a) for the analysis of nonconformities (including customer complaints);
b) determining the causes of nonconformities;
c) an assessment of the need for action to ensure the exclusion of recurrence of nonconformities;
g) determining and implementing action needed;
d) records of results of action taken (see 4.2.4);
e) to analyze the corrective action taken.
8.5.3 Preventive action
The organization shall determine action to eliminate potential nonconformities to prevent their occurrence. Preventive actions shall conform to the consequences of potential problems.
There should be a documented procedure established to define (install it) requirements:
a) determining potential nonconformities and their causes;
b) an assessment of the need for action to prevent occurrence of nonconformities;
a) determining and implementing action needed;
g) records of results of action (si. 4.2.4), as well as
e) to analyze the preventive action taken.
