What changes will ISO 9001:2015 bring?

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Derek Pope
8 years ago
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1 What changes will ISO 9001:2015 bring? 1

2 Introduction This presentation will cover the following topics: The ISO 9001 Revision Process Key Inputs to ISO 9001:2015 The High Level Structure Key Changes in ISO 9001:2015 Implementation of the HLS in ISO 9001:2015 2

Inputs to ISO 9001:2015 The High Level Structure Key

3 ISO 9001 revision process 3

4 Key Inputs to ISO 9001:2015 ISO Mission Develop high quality voluntary International Standards: Facilitate international exchange of goods & services Support sustainable and equitable economic growth Promote innovation Protect health, safety and environment 4

exchange of goods & services Support sustainable and equitable

5 ISO Mission Develop, maintain and support products* that enable organizations worldwide to improve their performance by establishing generic QMS requirements providing guidance and support. * ISO 9000, ISO 9001, ISO 9004 & other guidance documents 5

establishing generic QMS requirements providing guidance and

6 Worldwide ISO 9001 survey A worldwide ISO 9001 survey was conducted. The survey questioned what the most important concepts were to follow for a successful QMS. The results were based on 6,299 answers and the top 6 concepts are as followed: 1. Integration of Risk Management 2. Resource Management 3. Systematic problem solving and learning 4. Voice of the customer 5. Knowledge management 6. Measures (examples are performance, satisfaction and ROI.) 6

The results were based on 6,299 answers and the top 6 concepts are as followed: 1.

7 Key Inputs Set of stable requirements to last 10 years, 2015 until Incentivate process approach and effective process management. INPUT Process OUTPUT Changes in practices to QMS and technology. Facilitate implementation in any organisation. Effective verification by first, second and third party organizations. Simplified language and text Quality Management Principles Process approach include concept of system Simpler language for better understanding. 7

INPUT Process OUTPUT Changes in practices to QMS and technology. Facilitate implementation in any organisation.

8 High Level Structure Alignment of management systems standards Identical titles and core text Generic basic vocabulary High-Level Structure Annex SL Common main structure, common sub-clauses common terms and definitions New Structure for Management Systems Standards 8

Structure Annex SL Common main structure, common sub-clauses

9 High Level Structure 9

10 High Level Structure 10

11 High Level Structure 11

12 Key Changes in ISO 9001:2015 Exclusions No text for possible exclusions of requirements Intent remains as per clause 1.2 of present standard Leadership Role of Management Representative eliminated Quality policy / objectives compatible with strategic direction Integration of QMS requirements into business processes Goods and services product goods and services New term to make the standard more generic and more applicable to service organizations 12

2 of present standard Leadership Role of Management Representative eliminated Quality policy / objectives

13 Key changes Reduction of the prescriptive nature of some Requirements Monitoring and measuring equipment Evidence of fitness for purpose Development of goods and services Processes for the development Control of development processes Development transfer Necessary documented information Context of the organization Two new clauses: 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 13

processes Development transfer Necessary documented information Context of the organization Two new clauses: 4.

14 Key changes Significant changes Process approach New clause: Process approach Determination of risk to conformity of goods and services and to customer satisfaction Knowledge as a resource Determine the knowledge necessary for the operation of the QMS and its processes Knowledge shall be maintained, protected and made available as necessary Foresee the need for changes in knowledge and the risk of not acquiring it in a planned and timely manner. 14

necessary for the operation of the QMS and its processes Knowledge shall be maintained, protected and made

15 Key changes Documented information No mention of a Quality Manual Outsourcing of goods and services Control of external provision of goods and services Risk-based approach to determine type and scope of controls Risk and preventive action Key purpose of a management system is to act as preventive tool Risk-based thinking introduced in all clauses * Risk = effect of uncertainty 15

type and scope of controls Risk and preventive action Key purpose of a management system is to

16 What is risk-based thinking? Something we all do automatically and often Subconsciously Concept of risk > always implicit in ISO 9001 Risk-based thinking already part of process approach makes preventive action part of the routine Risk often seen as negative Risk-based thinking can also help identify opportunities = positive risk 16

implicit in ISO 9001 Risk-based thinking already part of process approach makes

17 Where is risk addressed in ISO 9001:2015? Main objectives of ISO 9001: To provide confidence in the organization s ability to consistently provide customers with conforming goods and services To enhance customer satisfaction The concept of risk relates to the uncertainty in achieving those objectives 17

ability to consistently provide customers with conforming goods and

18 Where is risk addressed in ISO 9001:2015? In Clause 4 > the organization is required to determine risks that can affect its ability to meet objectives In Clause 5 > top management are required to commit to ensuring Clause 4 is followed In Clause 6 > the organization is required to plan and take action to address risks and opportunities In Clause 8 > the organization is required to have processes which identify and address risk in its operations In Clause 9 > the organization is required to consider risks and opportunities when determining what needs to be monitored, measured, analyzed and evaluated In Clause 10 > the organization is required to improve by responding to changes in risk and opportunities 18

Clause 4 is followed In Clause 6 > the organization is required to plan and take action to address risks and opportunities In Clause 8 > the organization is required to have

19 What should you do? 19

20 Implementation of the High-Level Structure 20

21 Implementation of the High-Level Structure 21

22 Implementation of the High-Level Structure 22

23 Implementation of the High-Level Structure 23

24 Implementation of the High-Level Structure 24

25 Model of a process-based QMS 25

26 Single process within the system 26

27 ISO 9001:2015 High Level Structure 27

28 Leadership 28

29 Leadership 29

30 ISO 9001:2015 High Level Structure 30

31 Planning 31

32 Planning 32

33 ISO 9001:2015 High Level Structure 33

34 Support 34

35 Support 35

36 Support 36

37 Support 37

38 ISO 9001:2015 High Level Structure 38

39 Operation 39

40 Operation 40

41 Operation 41

42 Operation 42

43 Operation 43

44 Operation 44

45 Operation 45

46 ISO 9001:2015 High Level Structure 46

47 Performance evaluation 47

48 Performance evaluation 48

49 ISO 9001:2015 High Level Structure 49

50 ISO 9001:2015 High Level Structure 50

51 ISO 9001:2015 High Level Structure 51

52 Conclusions More leadership and commitment from top management Process approach as a requirement Risk definition and management Quality objectives at relevant functions, levels and Processes Organizational knowledge as a resource Documented information Planned and controlled operation Performance evaluation 52

53 It is not yet September 2015 This is not the final version... Some things can change... Hopefully the new standard will come out right 53

ISO 9001 and the Supply Chain

ISO 9001 and the Supply Chain John DiMaria; CSSBB, HISP, MHISP, AMBCI Sr. Product Manager, Systems Certification - Americas Provide insight into understanding of Clause 4. Context of the Organization Discuss