There are 3 general
requirements and five specific requirements and they are numbered as such.
i.
Scope: This specifies requirements for a quality management system
where an organization has to demonstrate its ability to consistently provide
product that meet customer and applicable regulatory requirements, and aims to
enhance customer satisfaction through the effective application of the system.
ii.
Normative Reference: The reference in the standard to the latest versions of the
documents ISO 9000:2001, Quality Management System, Fundamentals and
Vocabulary.
iii.
Terms and Definitions: Terms and definitions related to
quality and quality management system are given.Quality is the degree to which
a set of inherent characteristics fulfils requirements.Quality management
system - is the management system that direct and control an organization with
regard to quality.
iv.
Documentation requirements: The requirement is
identified for establishing, documenting, implementing, maintaining and
continuously improving. The quality management system documentation shall at
least include quality policy quality objectives quality manual documented
procedure and the documents necessary to ensure the effective operation and
control of its process.
Quality
Policy- Top management shall ensure that there is a quality policy,
which is appropriate to the organization and provide a framework for setting,
reviewing and meeting requirements.
- The policy should reflect the following that it:-
- Is appropriate to the purpose of the organization.
- Include a commitment to comply with requirements and to continually improve the effectiveness.
- Provides a framework for establishing and reviewing quality objectives.
- Is communicated and understood within the organization.
- Is reviewed for continuing suitability.
Example:-
Quality
Policy
We are committed to
fulfill the needs and expectations of our esteemed customers and delight them
with quality of products as well as prompt and efficient services.We shall do
this through complying with customers as well as statutory objectives establishing and reviewing quality policy and
quality objectives.
Quality
manual – The organization will require a quality manual, which will include,
scope of the quality system.
Control
of records - As in the case of documents a documented producer is required
to prepare, maintain and dispose of records.
v.
Management Responsibility: Top management shall provide its
commitment to the development and improvement of its quality management system.Communicate
within the organization the importance of meeting customer and regulatory
requirements, set policies and objectives and lead the organization by
providing necessary resources and conduct the management reviews.
vi.
Resource Management: Personal responsible for implementing quality management system
shall be competent to carryout the assigned tasks. This can be achieved through
education training, skills or experience.
vii. Production Realization: Organizational
processes must be planned and developed and these must be consistent with other
requirements.
viii.
Measurement Analysis and Improvement: The organization shall
plan and implement the use of monitoring measurement analysis and improvement
process to ensure conformity of the product and the quality management system.
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