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8.

- MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Ing. Naty A. Romero Alarcn

8.1 Generalities
8.2 Monitoring and Measurement
8.3 Non Conformity Product Control
8.4 Data Analysis
8.5 Improvement

8.1 GENERALITIES

The organization must plan and implement the


necessary processes of monitoring, measurement,
analyses and improvement.
This must include the determination of the
applicable methods, including the statistical
techniques and the reach of its use

8.2.1 CUSTOMER

SATISFACTION

As one of the QMS perfomance measures, the


organization must realise the pursuit of the
information regarding the perception of the client with
respect to the requirements fulfillment by the
organization.
The methods must be determined to obtain and to use
the data. Examples: Complaints of the client,
questionnaires and surveys, studies of sector and
industry.

8.2.2 INTERNAL AUDIT


The organization must carry out at planned
intervals, internal audits to determine if the
QMS:
a)
Its in agreement with the dispositions, the
requirements of this standard and the
requirements of the QMS established by the
organization.
b)
It has implemented and stays in an effective
way.

8.2.2 INTERNAL AUDIT


c) An audits program is due to plan.
d) It should define the audit criteria.
e) The selection of the auditors and the
accomplishment of the audits must assure the
objectivity and impartiality of the audit process.
f) The responsibilities and requirements for the
planning and accomplishment of audit must be
defined in a documented procedure.

8.2.3 MONITORING AND MEASUREMENT


PROCESSES
The organization must apply appropriate
methods for the monitoring, and when it is
applicable, the measurement of the processes of
the QMS.
These methods must demonstrate the capacity of
the processes to reach the planned results.
When the planned results are not reached,
corrections and remedial actions must be carried
out, according to is advisable, to make sure the
conformity of the product.

8.2.4 MEASUREMENT AND MONITORING


PRODUCT

The organization:
It must measure and to make monitoring of the product
characteristics, this must be realised in the appropriate
stages of the process of accomplishment of the product in
agreement with the planned dispositions.
Evidence of the conformity with the defect acceptance
numbers must stay. The registries must indicate the people
who authorize the liberation of the product.
It shouldnt do a liberation from the product or the benefit
of the service until they are satisfactorily completed the
planned dispositions unless they are approved by a
competent authority or when it corresponds by the client.

8.3 NON CONFORMITY PRODUCT CONTROL

The organization must make sure that the product that is not in
agreement with the requirements, is identified and controlled to
prevent its use or gives nondeliberate.
The organization must treat non conformity products by means of:
Taking action to eliminate the nonconformity.
Authorizing its use, liberation or acceptance under concession by
a pertinent authority.
Taking action to prevent its use or anticipated original
application.

8.4 DATA ANALYSIS

The organization must determine, collect and


analyze the appropriate data to demonstrate the
suitability and the effectiveness of the QMS.
This must include the generated data of the
result of the measurement and pursuit. Example:
The satisfaction of the client, the conformity with
the requirements of the product, and so forth.

8.5.1 CONTINOUS IMPROVEMENT

The organization must improve the effectiveness


of the QMS by the use of:
Quality Policy.
Quality Objectives.
Audit Results.
Data Analysis.
Corrective Actions and Preventive Actiones.
Management Review.

8.5.2 CORRECTIVES ACTIONS


The organization must take action to eliminate
the cause of non conformities in order to prevent
the repetition.
The remedial actions must be appropriate for the
purposes of the found nonconformities.

8.5.3 PREVENTIVES ACTIONS

The organization must determine action to


eliminate the potential causes of non conformities
to prevent the repetition. The taken preventive
actions must be appropriate for the purposes of
the potential problems.

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