6th sem b pharma QC,QA pharmaceutical quality assurance Quality Management System Introduction to ISO 9000 Eight Quality Management Principles ISO 9000 Series Advantages Clauses Introduction to ISO 14000 Standards under ISO 14000 series NABL accreditation ( National Accreditation Board for Testing and Calibration Laboratories) Function of NABL Process of NABL

1. ISO 9000 AND 14000
NABL ACCREDITATION
Himanshu Kamboj
Assistant Professor

2. Contents
• Quality Management System
• Introduction to ISO 9000
• Eight Quality Management Principles
• ISO 9000 Series
• Advantages
• Clauses
• Introduction to ISO 14000
• Standards under ISO 14000 series
• NABL accreditation ( National Accreditation Board for
Testing and Calibration Laboratories)
• Function of NABL
• Process of NABL

3. Quality Management
System
• A quality management system (QMS) defines and
establishes an organization's quality policy and objectives.
• It also allows an organization to document and implement the
procedures needed to attain these goals.
• 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.
• 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

4. Introduction to 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 eight
management principles on which the family of
standards is based.

5. • Originally published in 1987 by the International
Organization for Standardization (ISO), a specialized
international agency for standardization composed of
the national standards bodies of 90 countries.
• ISO 9000 is a series of Quality Management System
(QMS) standards, provide guidance and tools for
companies and organizations, to ensure that their
products and services consistently meet customer’s
requirements, and for consistent improvement in
quality.

6. Eight Quality Management Principles
Customer
focus
Leadership Involvement
of people
Process
approach
System
approach to
management
Continual
improvement
Factual
approach to
decision-
making
Mutually
beneficial
supplier
relationships

7. Customer focus
• Organizations depend on their customers and
therefore should understand current and future
customer needs, should meet customer
requirements, strive to exceed customer
expectations, assess customer satisfaction and
customer relationships

8. Leadership
• Leaders establish unity of purpose and direction of
the organization. They should create and maintain
the internal environment within the organization.
• Establish a vision and direction for the organization
• Set demanding goals
• Model organizational values
• Establish trust
• Train and empower employees
• Identify employee contributions

9. Involvement of people
• People at all levels are the essence of an
organization and their full involvement enables their
abilities to be used for the organization's benefit.
• Ensure that people’s skills are used and valued
• Make people responsible
• Enable participation in continual improvement
• Evaluate individual performance
• Facilitate learning and sharing of knowledge
• Enable open discussion of problems and constraints

10. Process approach
• A desired result is achieved more efficiently when
activities and related resources are managed as a
process.
• Supervise activities as processes
• Assess the capability of activities
• Identify linkages between activities
• Prioritize improvement opportunities
• Organize resources effectively

11. Improvement
• Improvement of the organization's overall
performance should be a permanent objective of
the organization.
• Develop organizational performance and capabilities
• Align advanced activities
• Empower people to make improvements
• Measure improvement consistently
• Celebrate the improvements

12. Evidence-based decision making
• Effective decisions are based on the analysis of data
and information.
• Guarantee the accessibility of accurate and
consistent data
• Use suitable methods to analyze data
• Make decisions based on analysis
• Balance data analysis with practical experience

13. Relationship management
• An organization and its external providers are
interdependent and a mutually beneficial relationship
enhances the ability of both to create value.
• Identify and select suppliers to manage costs, optimize
resources, and create value
• Establish relationships considering both the short and long
term
• Share expertise, resources, information, and plans with
partners
• Collaborate on improvement and development activities
• Recognize supplier successes.

14. • These standards provide guidance.
• Tools to ensure products and services meet customer’s
requirements.
• Quality is consistently improved.

15. ISO 9000 Series
• Explains fundamental quality concepts
and provides guidelines for the selection
and application of each standard
ISO 9000
• Model for quality assurance in design,
development, production, installation
and servicing.
ISO 9001
• Model for quality assurance in the
production and installation of
manufacturing systems
ISO 9002

16. • Quality assurance in final
inspection and testing.
ISO
9003
• Guidelines for the applications of
standards in quality management
and quality systems.
ISO
9004
ISO 9000 and ISO 9004 are guidance standards.
They describe what is necessary to accomplish
the requirements outlined in standards 9001,
9002 or 9003.

17. Advantages
 Quality is maintained,
 ISO registration also has a significant bearing on market credibility as well.
 Opportunity to compete with larger companies
 More time spent on customer focus,
 Confirmation that your company is comitted to quality,
 May facilitate trade and increased market opportunities,
 can increase customer confidence and satisfaction.

18. • Quality Management System
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement
Clause 4
Clause 5
Clause 6
Clause 7
Clause 8
Clauses
The requirements of the standard are specified in following
clauses of the standard:

19. • Quality Management Clause
▫ General requirements
▫ Documentation requirement
▫ Quality manual
▫ Control of records and documents
• Management responsibility clause
▫ Customer focus
▫ Quality objective
▫ Quality policy
▫ Quality management system planning
▫ Management representative
▫ Internal communication

20. • Resource management requirement clause
▫ Competence, awareness and training
▫ Infrastructure
▫ Work environment
• Product realization requirement clause
▫ Planning of product realization
▫ Customer related process
▫ Customer communication
• Measurement, analysis and improvement clause
▫ General requirements
▫ Monitoring and measurement
customer satisfaction
Internal audit
▫ Analysis of data
▫ Continual improvement

28. ISO 14000
• Environmental management
• Help organizations to work within healthy
environment
• Help to meet the challenge of climate change
• Develop 570 international standards

29. Standards under ISO 14000 series
• ISO 14001: Set criteria for EMS
• ISO 14010: Standards about auditing
• ISO 14020: Standards about environmental labeling
• ISO 14030: Standards on environmental
performance evaluation
• ISO 14040: Standards on environmental life cycle
assessment

30. Advantages
 Creates a more efficient, effective operation
 Increases customer satisfaction and retention
 Reduces audits
 Enhances marketing
 Improves employee motivation, awareness, and morale.
 Promotes international trade
 Increases profit
 Reduces waste and increases productivity
 Common tool for standardization
 Enables to meet the requirements of an internationally uniform quality system.
 Motivates the employees and develops pride in them for achieving excellence.

31. THANK YOU