International organisation for Standardization

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

1. Presenter: Amruta Balekundri M.Pharm 1 st semester, Department of Pharmaceutical Quality Assurance, KLE College of Pharmacy, Belagavi. 1

2. Contents Introduction History Present scenario Benefits of ISO ISO 9001:2008 ISO 9001:2015 ISO 14001:2004 ISO 14001:2015 2

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. 3

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. 4

5. Present Scenario: Today they have  members  from 162 countries and 784  technical committees and subcommittees  to take care of standards development. And m ore than 135 people work full time for ISO’s Central Secretariat in Geneva, Switzerland. 5

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. 6

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 7

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 8

9. 1. Scope 9

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 10

11. 3. Terms & Definitions This clause usually defines key terms and words used in the standards. 11

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  12

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 13

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  14

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 15

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  16

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 17

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 18

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 19

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 20

21. ISO 9001:2015 Main Objectives 21

22. ISO 9001:2015 Timeline 22

23. ISO 9001:2015 Certification Transition 23

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

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29. Plan-Do-Check-Act Cycle (PDCA Cycle) 29

30. Risk Based Thinking 30

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32. Clause 3 Terms and Definitions 32

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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. 40

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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 43

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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. 49

50. References: https://www.iso.org/about-us.html Juran ‘s Quality Handbook, 5 th edition, --Joseph M.Juran 50