EXCLUSIVELY FOR BPHARM VI SEMESTER AS PER PCI SYLLABUS

1. TOPIC: ISO PART -I
BY
Mr.DIPANKAR NATH.
M.PHARM(PHARM.CHEMISTRY),GATE(2009),GPAT(2011)
ASSISTANT PROFESSOR.
DEPARTAMENT OF PHARMACEUTICAL ANALYSIS .
HIMALAYAN PHARMACY INSTITUTE,MAJHITAR,EAST SIKKIM.

2. INTRODUCTION:
 ISO is a name used for the International Standard Organization is the worlds largest
developer and Publisher of International Standard.
 Formed in 1947 in Geneva, Switzerland .
 The International Organization for Standardization (ISO) is an independent, non-
governmental international organization with a membership of 162 national standards
bodies.
 The three official language of the ISO are English, French, and Russian.
 The main Concept is to determine characteristics of the management practices that must
be standardized.

3. Objectives:
 To provide products that is customer focused or oriented.
 To produce products that meets customers requirements.
 To enhance customer satisfaction for the products and their trust in it.
 To enhance quality management.
 To enhance effective and efficient products design and development
Difficulties: Many countries initiated and implemented their own National Quality Policies.
Two main features:
 Internal Quality audit at predetermined level.
 Continuous monitoring of quality system.

4. Benefits:
ISO International Standards ensure that products and services are safe, reliable and of good
quality. For business, they are strategic tools that reduce costs by minimizing waste and errors,
and increasing productivity. They help companies to access new markets, level the playing
field for developing countries and facilitate free and fair global trade
ISO Popular Standards:
ISO 9000 - Quality management
ISO 14000 - Environmental management
ISO 45001 - Occupational Health and Safety
ISO 27001 - Information security
ISO 26000 - Social responsibility
ISO 50001 - Energy management

5. ISO 3166 - Country codes
ISO 4217 - Currency codes
ISO 639 - Language codes
ISO 22000 - Food safety management
ISO 20121 - Sustainable events
ISO 13485 - Medical devices
ISO 31000 - Risk management
ISO 37001 - Anti-bribery management systems
ISO 8601 - Date and time format

6. Quality Management System:
A quality management system (QMS) defines and establishes
an organization's quality policy and objectives.
1. It also allows an organization to document and implement the procedures needed to
attain these goals.
2. A properly implemented QMS ensures that procedures are carried out consistently, that
problems can be identified and resolved, and that the organization can continuously
review and improve its procedures, products and services.
3. It is a mechanism for maintaining and improving the quality of products or services so
that they consistently meet or exceed the customer's implied or stated needs and fulfill
their quality objectives.

7. ISO 9000
 The ISO 9000 family of standards is related to quality management systems and designed to
help organizations ensure that they meet the needs of customers and other stakeholders while
meeting statutory and regulatory requirements.
 ISO 9000 deals with the fundamentals of quality management systems, including the seven
management principles on which the family of standards is based.
The seven quality management principles are :
QMP 1 – Customer focus
QMP 2 – Leadership
QMP 3 – Engagement of people
QMP 4 – Process approach
QMP 5 – Improvement

8. QMP 6 – Evidence-based decision making
QMP 7 – Relationship management

9. QMP 1 – Customer focus
 The primary focus of quality management is to meet customer requirements and to strive to
exceed customer expectations.
Key benefits
• Increased customer value
• Increased customer satisfaction
• Improved customer loyalty
• Enhanced repeat business
• Enhanced reputation of the organization
• Expanded customer base
• Increased revenue and market share

10. QMP 2 – Leadership
 Leaders at all levels establish unity of purpose and direction and create conditions in which
people are engaged in achieving the organization’s quality objectives.
Key benefits
• Increased effectiveness and efficiency in meeting the organization’s quality objectives
• Better coordination of the organization’s processes
• Improved communication between levels and functions of the organization
• Development and improvement of the capability of the organization and its people to deliver
desired results.
QMP 3 – Engagement of people
Competent, empowered and engaged people at all levels throughout the organization are
essential to enhance its capability to create and deliver value.

11. Key benefits
• Improved understanding of the organization’s quality objectives by people in the
organization and increased motivation to achieve them.
• Enhanced involvement of people in improvement activities.
• Enhanced personal development, initiatives and creativity.
• Enhanced people satisfaction.
• Enhanced trust and collaboration throughout the organization.
• Increased attention to shared values and culture throughout the organization.
QMP 4 – Process approach
 Consistent and predictable results are achieved more effectively and efficiently when
activities are understood and managed as interrelated processes that function as a coherent
system.

12. Key benefits
• Enhanced ability to focus effort on key processes and opportunities for improvement.
• Consistent and predictable outcomes through a system of aligned processes.
• Optimized performance through effective process management, efficient use of resources,
and reduced cross-functional barriers.
• Enabling the organization to provide confidence to interested parties as to its consistency,
effectiveness and efficiency.
QMP 5 – Improvement
Successful organizations have an ongoing focus on improvement.
Key benefits
• Improved process performance, organizational capabilities and customer satisfaction
• Enhanced focus on root-cause investigation and determination, followed by prevention and
corrective actions

13. • Enhanced ability to anticipate and react to internal and external risks and opportunities.
• Enhanced consideration of both incremental and breakthrough improvement.
• Improved use of learning for improvement.
• Enhanced drive for innovation.
QMP 6 – Evidence-based decision making
 Decisions based on the analysis and evaluation of data and information are more likely to
produce desired results.
Key benefits
• Improved decision-making processes ability to demonstrate the effectiveness of past decisions.
• Improved assessment of process performance and ability to achieve objectives.
• Improved operational effectiveness and efficiency.
• Increased ability to review, challenge and change opinions and decisions.

14. QMP 7 – Relationship management
For sustained success, an organization manages its relationships with interested parties, such as
suppliers.
Key benefits
• Enhanced performance of the organization and its interested parties through responding to the
opportunities and constraints related to each interested party.
• Common understanding of goals and values among interested parties.
• Increased capability to create value for interested parties by sharing resources and
competence and managing quality-related risks.
• A well-managed supply chain that provides a stable flow of goods and services.

15. ISO 9000 Series
ISO 9000
ISO 9001
ISO 9002
ISO 9003
ISO 9004
Explains fundamental quality concepts and provides guidelines for the
selection and application of each standard
Model for quality assurance in design, development, production, installation
and servicing.
Model for quality assurance in the production and installation of
manufacturing systems
Quality assurance in final inspection and testing.
Guidelines for the applications of standards in quality management and quality
systems
ISO 9000 and ISO 9004 are guidance standards. They describe what is necessary to
accomplish the requirements outlined in standards 9001,9002 or 9003.