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Unit 10: Quality Management System
to meet customer, legal, and regulatory expectations, establishing a quality policy, ensuring Notes
that quality objectives are achieved, conducting management reviews, and ensuring that
the resources needed are available.
(b) Customer focus: Top management shall also ensure that customer requirements are
determined and met with the aim of enhancing customer satisfaction.
(c) Quality policy: Management must ensure that quality policy of the organization is
appropriate to its mission, define its commitment to comply with requirements and for
continuous improvement of the QMS, provides for establishing and reviewing quality
objectives.
(d) Planning: Top management is responsible for establishing quality objectives and these
objectives shall be measurable and be in line with quality policy of the organization. Top
management shall also ensure that the planning of the QMS is accomplished in order to
meet the requirements of QMS.
(e) Responsibility, authority and communication: Top management must ensure that
responsibilities and authorities are defined and communicated within the organization.
Responsibilities can be defined in job descriptions, procedures, and work instructions.
Authority and interrelationships can be defined in organization charts. Top management
shall also appoint a management representative, who regardless of his other duties, shall
be responsible for ensuring that the processes needed for the QMS system are established,
implemented and maintained. Top management shall also ensure that appropriate
communication channels are established within the organization and communication
takes place regarding the QMS.
(f) Management review: Top management shall review the QMS at planned intervals to ensure
its continuing suitability, adequacy and effectiveness. The input to review shall include
information on results of audits, customer feedback, status of corrective performance,
follow up actions from previous reviews and recommendations for improvement.
10.2.6 Resource Management
(a) Provisions of resources: Organization must determine and allocate resources needed to
implement and maintain QMS and improve its effectiveness, and to enhance customer
satisfaction. This includes all resources like people, infrastructure, work environment,
information, suppliers, natural resources, and financial resources.
(b) Human resources: All the employees involved in any task which affects product quality
shall be competent and organization shall determine competence necessary for performing
work. It shall provide training to develop those competencies.
(c) Infrastructure: The organization shall determine, provide and maintain the infrastructure
needed to achieve conformity to product requirements. This includes buildings, workspace,
and associated utilities, process equipment, and supporting services.
(d) Work environment: The organization shall determine and manage work environment
needed to achieve conformity to product requirements.
10.2.7 Product Realization
(a) Planning of product realization: Organization shall plan and develop processes needed
for product realization. Organization shall determine quality objectives and requirements
of the product, the need to establish processes, documents, and provide resources, validating
activities and criteria for product acceptance, and the records needed to provide evidence
for the product realization.
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