It is all about Quality management system within pharmaceutical company.

1. SOBIT POUDEL
SCHOOL OF HEALTH AND ALLIED SCIENCES
POKHARA UNIVERSITY
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2. Session Overview
 ISO 9001 and ISO 14001
 Quality management system
 Objectives
 Components
 Benefits of quality management system
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3. ISO 9001 and ISO 14001 in brief
 ISO 9001 and ISO 14001 are the among ISO’s most well
known standards ever.
 They are implemented by more than a million
organization in some 175 countries.
 ISO 19001 helps organization to implement quality
management.
 ISO 14001 helps organization to implement
environment management.
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4. Quality management
 ISO 9001 is quality management .
 Quality refers to all those features of a product or service
which are required by the customer.
 Quality management means what the organization does to
ensure that its products or service satisfy the customer’ s
quality requirement.
 Comply with any regulation applicable to those products
or service.
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5. Management system
 Management system means what the organization does to
manage its process or activites in order that its product or
services meet the organization’s objectives, such as
Satisfying the customer’s quality requirement
Complying to regulations or
Meeting environment objectives.
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6. Management system( conti…
 To be really efficient and effective, the organization
can manage its way of doing things by systemizing it.
 Nothing important is left out.
 Everyone is clear about who is responsible for doing
what, when, how and where.
 Large organization or one with complicated processes
could not function well without management system.
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7. Introduction
 A quality management system (QMS) is a formalized
system that documents processes, procedures, and
responsibilities for achieving quality policies and
objectives.
 A QMS helps coordinate and direct an organization’s
activities to meet customer and regulatory requirements
and improve its effectiveness and efficiency on a
continuous basis.
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8. Introduction
 ISO 9001:2015, the international standard specifying
requirements for quality management systems, is the most
prominent approach to quality management systems.
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9. Objectives
To give
arguments for
certification.
To analyse the
opportunity of
implementing
Quality
Management
Systems (QMS)
in NMAs;
To develop
arguments for
justifying the
use of QMS
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10. Components
 The active and positive commitment of senior
management.
 Good two-way communication throughout the
organisation that encourages a culture of initiative and
improvement.
 Simple, efficient monitoring systems that enable all levels
of management to identify bottlenecks and waste.
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11. Benefits of quality management
system
Meeting the customer’s requirements, which helps to
instill confidence in the organization, in turn leading to
more customers, more sales, and more repeat business.
Meeting the organization's requirements, which ensures
compliance with regulations and provision of products and
services in the most cost- and resource-efficient manner,
creating room for expansion, growth, and profit.
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12. Elements and requirements of a
quality management system
 The organization’s quality policy and quality objectives
 Quality manual Procedures,
 Instructions, and records
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13. Establishing and implementing a QMS
 There are many things to consider when establishing a
QMS for any organization.
 Of great importance is ensuring it is a strategic choice
influenced by the varying objectives, needs, and
products and services provided.
 This structure is based largely on the Plan-Do-Check-
Act (PDCA) and allows for continuous improvement
to both the product and the QMS.
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14.  The basic steps to implementing a quality
management system are as follows:
 Design
 Build
 Deploy
 Control
 Measure
 Review
 Improve
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15. Design and build
 The design and build portions serve to develop the
structure of a QMS, its processes, and plans for
implementation. Senior management must oversee
this portion to ensure the needs of the organization
and the needs of its customers are a driving force
behind the systems development.
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16.  Deploy
Deployment is best served in a granular fashion via
breaking each process down into sub-processes, and
educating staff on documentation, education, training
tools, and metrics. Company intranets are increasingly
being used to assist in the deployment of quality
management systems.
 Control and measure
Control and measurement are two areas of establishing a
QMS that are largely accomplished through routine,
systematic audits of the quality management system. The
specifics vary greatly from organization to organization
depending on size, potential risk, and environmental
impact.
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17.  Review and improve
Review and improvement deal with how the results of
an audit are handled. The goals are to determine the
effectiveness and efficiency of each process toward its
objectives, to communicate these findings to the
employees, and to develop new best practices and
processes based on the data collected during the audit.
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18. QMS and ISO 9000
 The ISO 9000 standard (ISO 9001,1994) provides
comprehensive guidance on the principles, scope and
implementation of a QMS.
 Many organizations successfully adopt a QMS without
an ISO 9000 certification, relying on their internal
review procedures to keep the whole process on track.
 IS0 9000 certification leads to formal review and
approval of the QMS by an outside body and, more
importantly, the certification body will review the
QMS every six months.
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19. The Risk of implementing QMS
 Short-term increase in production costs during
training and implementation of the QMS.
 Dissatisfaction of staff because of new methodology –
e.g. resistance to change and perceived risk of
‘exposure’
 Another set of rules and papers without actual results
– e.g. documents that reflect
 No improvement of the quality level in the final
product – additional bureaucratic effort with no gain.
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