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Total Quality Management
Notes Analysis and Improvement are requirements that an organization must meet. They are explained
below:
10.2.1 Scope
The purpose of the standard is for the organization to demonstrate its ability to provide a
product that meets customer and regulatory requirements and achieve customer satisfaction.
This is achieved by continuous improvement of the system, rather than the product.
10.2.2 Normative Reference
ISO 9000:2000 Quality Management Systems – Fundamentals and vocabulary are normative
reference that provides applicable concepts and definitions.
10.2.3 Terms and Definitions
For the purposes of this standard, the terms and definitions given in ISO 9000:2000 apply.
In addition the supply chain is defined as:
Supplier ⎯⎯⎯ Organization ⎯⎯⎯ Customer
10.2.4 Quality Management Systems (QMS)
(a) General Requirements: Organization shall establish, document, implement, and maintain
a QMS and continually improve its effectiveness. The organization shall:
Identify needed processes such as management activities, provision of resources,
product realization, and measurement.
Determine their sequence and interaction.
Determine criteria and methods for effective operation and control of these processes.
Ensure the availability of resources and information necessary to support and monitor
these processes.
Monitor, measure, and analyze these processes.
Implement actions to achieve planned results and continuous improvement of these
processes.
(b) Documentation: General documentation includes a quality policy, a quality manual,
required documented procedures, documents needed to ensure effective planning,
operation and control of processes and various records required. A quality manual shall
be established and maintained and it must contain information related cope of QMS,
documented procedures and description of interactions among QMS processes. All the
documents required by QMS shall be controlled and this includes approval of documents
prior to their use, review, updation and re-approve as necessary, identifying current
revision status, and prompt removal of obsolete documents. Records must be established
and maintained to provide evidence of conformity to requirements and effective operation
of QMS. Records must be legible, readily identifiable and retrievable.
10.2.5 Management Responsibility
(a) Management commitment: Top management should be committed for continuous
improvement and it shall demonstrate through the evidence by communicating the need
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