8. Measurement, analysis and improvement

8.1 General

The organization shall plan and implement the monitoring, measurement, analysis and improvement required to:

a) demonstration Conformity product

b) ensure Conformity quality management system, and

a) continuous improvement effectiveness of the QMS.

This shall include determination of applicable methods, including statistical, and utilization.

8.2 Monitoring and Measurement

8.2.1 Customer satisfaction

[Hidepost = 3] One of the criteria for the operation of the QMS, the organization shall monitor information on consumer perceptions of "how its requirements were met." Should be defined methods for obtaining and using this information.

8.2.2 Internal Audit

The organization shall conduct internal audits at planned intervals, to determine how the QMS:

a) corresponds to planned activities (see 7.1), the requirements of this

International standards and requirements for quality management system established by the organization, and

b) effectively implemented and is supported.

The audit program should be planned taking into account the status and importance of the processes and areas inspected and the results of previous of audits. Criteria audit scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors should not audit their own the work.

A documented procedure shall establish responsibilities and requirements for planning, conducting audits, registration statements and post the results.

Records of audits and their results must be maintained (see 4.2.4).

Leadership of the entity must ensure the implementation of any corrections and corrective action without delay to eliminate detected nonconformities and their causes. Follow-up should include a check of the actions taken and report on the audit (see 8.5.2).

NOTE See ISO 19011 for guidance.

8.2.3 Monitoring and measurement processes

The organization shall apply suitable methods for monitoring and, where applicable, measurement of QMS processes. These methods shall demonstrate the ability of processes to achieve planned results. When planned results are not achieved, correction and corrective action should be taken accordingly.

NOTE: When appropriate methods are chosen, it is desirable that the organization decided on the type and quantity of monitoring or measurement appropriate to each of its processes with regard to their influence on the product meets the requirements and effectiveness of the QMS

8.2.4 Monitoring and measurement of product

The organization shall monitor and measure the characteristics of the product to verify that product requirements are fulfilled. This should be carried out at appropriate stages in the process of creating a product in accordance with planned arrangements (see 7.1).

Proof of compliance with the acceptance criteria must be documented. In the records must be provided commissioner responsible for the release of the product for shipment to the customer (see 4.2.4).

Product release and provide [/ hidepost] services must not occur until the planned arrangements (see 7.1) will be completed with a satisfactory result or until approved by the appropriate authority and, if applicable, the consumer.

8.3 Control of nonconforming product

The organization shall ensure that the product meet the requirements identified and controlled to prevent its unintended use or the supply. The documented procedure must define management and related responsibilities and authorities for dealing with inappropriate product

Where applicable, the organization must deal with the inappropriate product of one or more of the following ways:

a) take steps to resolve the discrepancy,

b) permit the use, release or take it with a departure authorized by the appropriate authorized person and, if applicable, the consumer,

c) take of on prevent its originally intended use or application.

d) take appropriate actions harm (or potential harm) if found inappropriate product after Delivery or its use has begun.

After correcting the inappropriate product must be cross-checked to demonstrate compliance.

Must be documented nature of nonconformities and any subsequent actions taken, including concessions obtained by the application (sm.4.2.4).

8.4 Analysis of data

The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and evaluation can be conducted where continuous improvement of the QMS. This should include data from monitoring and measurement, as well as from other relevant sources.

Analysis Data should provide information on:

a) Satisfaction consumer (Sm.8.2.1)

b) Conformity requirements to product (see 7.2.1)

a) performance trends, processes and products including opportunities for preventive Action (See 8.2.3, 8.2.4), and

g) of suppliers.

8.5 Improve

8.5.1 Continuous Improvement

The organization shall continually improve the effectiveness of the QMS, using the policy and quality objectives, audit results, data analysis, corrective and preventive actions and management review.

8.5.2 Corrective of

The organization shall take [hidepost = 3] actions aimed at addressing the causes of nonconformities in order to prevent their repetition. Corrective actions shall be be adequate consequences of identified discrepancies.

A documented procedure shall establish requirements for:

a) analysis of nonconformities (including customer complaints),

b) definition causes inconsistencies

a) assess the need for actions to ensure that nonconformities do not recur,

g) definition and implementation necessary action,

e) Registration results action taken (see 4.2.4), and

e) analysis of the impact of the corrective action taken.

8.5.3 Preventive action

The organization shall determine action to eliminate causes of potential nonconformities to prevent their occurrence. Preventive actions shall be be adequate potential problems.

Documented procedure shall establish requirements for:

a) definition potential nonconformities and their causes,

b) evaluation necessary Action on [/ hidepost] prevent the occurrence of nonconformities,

a) definition and implementation necessary action,

g) Registration results action taken (see 4.2.4)

e) analysis of the impact of preventive action taken.