ISO 9001:2008 ISO 9001:2015 ISO 140001:2004 ISO 14001:2015

1. Presenter:
Amruta Balekundri
M.Pharm 1st semester,
Department of Pharmaceutical
Quality Assurance,
KLE College of Pharmacy,
Belagavi.
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2. Contents
• Introduction
• History
• Present scenario
• Benefits of ISO
• ISO 9001:2008
• ISO 9001:2015
• ISO 14001:2004
• ISO 14001:2015
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3. Introduction:
ISO-‘International Organization for Standardization’
• ISO is an independent, non-governmental international
organization with a membership of 162 national standards
bodies.
• Through its members, it brings together experts to share
knowledge and develop voluntary, consensus-based,
market relevant International Standards that support
innovation and provide solutions to global challenges.
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4. History:
• The ISO story began in 1946 when delegates from 25
countries met at the Institute of Civil Engineers in
London and decided to create a new international
organization ‘to facilitate the international
coordination and unification of industrial standards’.
• On 23 February 1947 the new organization, ISO,
officially began operations.
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5. Present Scenario:
• Today they have members from 162 countries and
784 technical committees and subcommittees to take
care of standards development.
• And more than 135 people work full time for ISO’s
Central Secretariat in Geneva, Switzerland.
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6. Benefits of ISO:
• 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.
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7. ISO 9000 series
• ISO 9000• Quality management systems
Fundamentals and vocabulary
• ISO 9001 Quality Management Systems Requirement
• ISO 9004 Managing for the sustained success of an
organization - A quality management approach
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8. ISO 9001:2008 Clauses:
1. Scope
2. Normative References
3. Terms & Definitions
4. Quality Management System
5. Management Responsibilities
6. Human Resources
7. Product Realization
8. Measurement, Analysis & Improvement
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9. 1. Scope
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10. 2. Normative References
• Normative references are other standards needed for
the complete implementation of ISO 9001:2008.
• Referenced documents are indispensable for the
application of this document.
• ISO 9001 Provides Common Ground Standards
which Normative reference ISO 9001 also require the
use of ISO 9000,example:ISO 13485:2003 Medical
devices-Requirements
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11. 3. Terms & Definitions
• This clause usually defines key terms and words used
in the standards.
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12. 4 .Quality Management System
4.1 General Requirements
4.2 Documentation requirements
 4.2.1 General Requirements
 4.2.2 Quality Manual
 4.2.3 Control of Documents
 4.2.4 Control of Records
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13. 5.Management Responsibility
5.1 Management Commitment Establish policy and
objectives (SMART) Communicate importance of
meeting customer and regulatory Requirements
Conducting Management Reviews Ensuring
availability of resources
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
 5.4.1 Quality Objectives
 5.4.2 QMS Planning
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14. 5.5 Responsibility, authority & communication
 5.5.1 Responsibility & authority
 5.5.2 Management Representative
 5.5.3 Internal Communication
5.6 Management Review
 5.6.1 General
 5.6.2 Review Input
 5.6.3 Review Output
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15. 6.Resource Management
6.1 Provision of Resources
6.2 Human Resources
 6.2.1 General
 6.2.2 Competence, training & awareness
6.3 Infrastructure
6.4 Work Environment
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16. 7.Product Realization
7.1 Planning of Product Realization
7.2 Customer Related processes
 7.2.1 Determination of requirements related to the
product
 7.2.2 Review of requirements related to the product
 7.2.3 Customer Communication
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17. 7.3 Design & Development
 7.3.1 Design & Development Planning
 7.3.2 Design & Development Inputs
 7.3.3 Design & Development Outputs
 7.3.4 Design & Development Review
 7.3.5 Design & Development Verification
 7.3.6 Design & Development Validation
 7.3.7 Control of Design & development Changes
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18. 7.4 Purchasing
 7.4.1 Purchasing process Vendor Selection & evaluation
 7.4.2 Purchasing Information
 7.4.3 Verification of Purchased product
7.5 Production & Service Provision
 7.5.1 Control of Production & Service Provision
 7.5.2 Validation of Production & Service Provision 7.5.3
Identification & Traceability
 7.5.4 Customer Property
 7.5.5 Preservation of Product
7.6 Control of Monitoring & Measuring Equipment
Calibration
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19. 8.Measurment Analysis & Improvement
8.1 General
8.2 Monitoring & Measurement
 8.2.1 Customer Satisfaction
 8.2.2 Internal Audit
 8.2.3 Monitoring & Measurement of Processes
 8.2.4 Monitoring & Measurement of Product
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20. 8.3 Control of Non-conforming Product
8.4 Analysis of Data Customer Satisfaction
Conformity to product requirements
8.5 Improvement
 8.5.1 Continual Improvement through policy,
objectives, audit results, analysis
 8.5.2 Corrective Action
 8.5.3 Preventive Action
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21. ISO 9001:2015
Main Objectives
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22. ISO 9001:2015 Timeline
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23. ISO 9001:2015 Certification Transition
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24. 24

25. 25

26. 26

27. Core Concepts of new standards
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• Process Approach
• Plan-Do-Check-Act Cycle (PDCA Cycle)
• Risk Based Thinking

28. 28

29. Plan-Do-Check-Act Cycle (PDCA Cycle)
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30. Risk Based Thinking
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31. 31

32. Clause 3 Terms and Definitions
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33. 33

34. 34

35. 35

36. 36

37. 37

38. 38

39. 39

40. Introduction to ISO 14001
• Environmental Management Systems: Requirements with
Guidance for use First published in 1996;
• second release in 2004 , One of the most successful
management system standards;
• Adopted by more than 270,000 certified users in 155
countries as of 2011
• All ISO standards are reviewed every 5 years to evaluate
if a revision is needed to make it current to the
marketplace.
• ISO 14001:2015 will adopt the latest trends to ensure
compatibility with other management system standards.
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41. 41

42. 42

43. Context of the Organization (Clause 4)
• To determine external and internal issues that could
affect the outcome of EMS
• To provide high level and conceptual understanding
on why and how to manage environmental
responsibilities;
• It is about EMS and its processes;
• Needs and expectations of interested parties; There is
no direct equivalent in current standard to this new
clause
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44. 44

45. 45

46. 46

47. 47

48. 48

49. Clause 10 – Improvement
• No clause in 2004 but implied as non-ending in the
structure;
• Improvement is a cycle in the new structure;
• Clause 4.5.3 „Nonconformity, corrective and
preventive action‟ was modified to clause 10.1
Nonconformity and corrective action‟ - preventive
action concept was removed since risk was added.
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50. References:
• https://www.iso.org/about-us.html
• Juran ‘s Quality Handbook, 5th edition,
--Joseph M.Juran
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