Page 149 - DMGT524_TOTAL_QUALITY_MANAGEMENT

Total Quality Management

Notes (b) Customer related processes: Organization shall also determine requirements specified by
customers, related delivery and post delivery services. It shall also determine any statutory
requirements related to product. It is also necessary to review the requirements related to
product. Organization shall determine and implement effective management for
communicating with customers in relation to product, and customer complaints.
(c) Design and development: Organization shall plan and control the design and development
activities of the product. Inputs relating to product requirements shall be determined and
records maintained. The outputs of design and development shall be provided in a form
that enables verification against the design and development input and shall be approved
prior to release. At suitable, stage, systematic reviews of design and development shall be
performed in accordance with the planned arrangements. Verification shall be performed
in accordance with planned arrangements to ensure that the design and development
outputs have met the design and development input requirements. Design and
development validation shall be performed in accordance with planned arrangements to
ensure that the resulting product is capable of meeting the requirements for the specified
application or intended use. Design and development changes shall be identified and
records maintained.
(d) Purchasing: The organization shall ensure that the purchased product conformed to
specified purchase requirements. Purchasing information shall describe product to be
purchased and its requirements. The organization shall establish and implement the
inspection to ensure the purchased product meets the specified purchase requirements.

(e) Production and service provision: The organization shall plan and carry out production
and service provision under controlled condition. The organization shall validate any
processes of production or service provision where the resulting output cannot be verified
by subsequent monitoring or measurement.
(f) Control of monitoring and measuring devices: The organization shall determine the
monitoring and measurement to be undertaken and the monitoring and measuring devices
needed to provide evidence of conformity of product to determined requirements. All
measuring instruments shall be calibrated at specified intervals.

10.2.8 Measurement, Analysis and Improvement

Organization shall plan and implement the monitoring, analysis, and improvement processes
needed to demonstrate conformity of the product, conformity to QMS and for continuous
improvement. Organization must monitor and measure customer satisfaction to ensure that it
has met customer requirements. Organization shall conduct internal audits at planned intervals
to check whether QMS conforms to planned arrangements and it is effectively implemented.
Organization shall apply suitable methods for monitoring. Organization shall ensure that product
which does not conform to product requirements is identified and controlled to prevent its
unintended use or delivery. Organization shall also determine, collect, and analyze appropriate
data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continuous
improvement of effectiveness of the QMS can be made. Organization shall continuously improve
the effectiveness of the QMS through the use of the quality policy, quality objectives, audit
results, analysis of data, corrective and preventive actions and management review. It shall also
take action to eliminate the cause of non-conformities in order to prevent recurrence.
10.2.9 Documentation

ISO 9000 documentation includes the following functions:
The quality policy is a formal statement from management, closely linked to the business
and marketing plan and to customer needs. The quality policy is understood and followed

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