ISO 9001 2008 to ISO 9001 2015 Summary

ISO 9001: 2008 to ISO 9001: 2015 Summary of Changes ISO/TC 176/SC 2/N 1282 1

Purpose of presentation ISO/TC 176/SC 2/ N 1282 The intention of this presentation is to: § Provide a summary of notable changes from ISO 9001: 2008 to ISO 9001: 2015 2 Date: 2

Key perspectives ISO 9001 needs to change, to: § adapt to a changing world § reflect the increasingly complex environments in which organizations operate ISO/TC 176/SC 2/ N 1282 § provide a consistent foundation for the future § reflect the increasingly complex environments in which organizations operate § ensure the new standard reflects the needs of all relevant interested parties § Ensure alignment with other management system standards 3 Date: 3

ISO/TC 176/SC 2/ N 1282 Key feature changes § 10 -clause structure and core text for all Management System Standards (MSS) § More compatible with services and non-manufacturing users § Clearer understanding of the organization’s context is required “one size doesn’t fit all” § Process approach strengthened/more explicit § Concept of preventive action now addressed throughout the standard by risk identification and mitigation § The term documented information replaces the terms document and record § Control of externally provided products and services replaces purchasing/outsourcing § Increased emphasis on seeking opportunities for improvement 4 Date: 4

Beneficial changes to ISO 9001 § Enhanced leadership involvement in the management system § Risk-based thinking ISO/TC 176/SC 2/ N 1282 § Simplified language, common structure and terms § Aligning QMS policy and objectives with the strategy of the organization 5 Date: 5

ISO/TC 176/SC 2/ N 1282 Potential benefits to the user § Focus on achieving planned results § Flexibility for documented information § Improved risk control § Better process control leading to improved results § Improved customer satisfaction § Customer retention and loyalty § Improved image and reputation § Greater credibility 6 Date: 6

Key benefits of the common clause structure A new common format has been developed § All ISO management systems standards will look the same with the same structure (some deviations) ISO/TC 176/SC 2/ N 1282 § More efficient to address multiple management system requirements § Provides the option of integrating management systems § Standardized core definitions 7 Date: 7

Structure of ISO 9001: 2015 (1/3) ISO/TC 176/SC 2/ N 1282 1 Scope 2 Normative references 3 Terms and definitions 4 Context of the organization 4. 1 Understanding the organization and its context 4. 2 Understanding the needs and expectations of interested parties 4. 3 Determining the scope of the quality management system 4. 4 Quality management system and its processes 5 Leadership 5. 1 Leadership and commitment 5. 2 Policy 5. 3 Organizational roles, responsibilities and authorities 6 Planning 6. 1 Actions to address risks and opportunities 6. 2 Quality objectives and planning to achieve them 6. 3 Planning of changes 8 Date: 8

ISO/TC 176/SC 2/ N 1282 Structure of ISO 9001: 2015 (2/3) 7 Support 7. 1 Resources 7. 2 Competence 7. 3 Awareness 7. 4 Communication 7. 5 Documented information 8 Operation 8. 1 Operational planning and control 8. 2 Requirements for products and services 8. 3 Design and development of products and services 8. 4 Control of externally provided processes, products and services 8. 5 Production and service provision 8. 6 Release of products and services 8. 7 Control of nonconforming outputs 9 Date: 9

Structure of ISO 9001: 2015 (3/3) 9 Performance evaluation 9. 1 Monitoring, measurement, analysis and evaluation 9. 2 Internal audit 9. 3 Management review ISO/TC 176/SC 2/ N 1282 10 Improvement 10. 1 General 10. 2 Nonconformity and corrective action 10. 3 Continual improvement 10 Date: 10

The common structure and ISO 9001: 2015 additions 4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance Evaluation 4. 1 Understanding context 5. 1 Leadership and commitment 6. 1 Risks and opportunities 7. 1 Resources 8. 1 Operational planning and control 9. 1 Monitoring, measurement, analysis and evaluation 4. 2 Interested parties 5. 2 Policy 6. 2 Planning 4. 3 Scope 5. 3 Organizational roles, responsibilities and authorities 7. 2 Competence 7. 3 Awareness 10 Improvement 10. 1 General 9. 2 Internal audit 10. 2 Nonconformity and corrective action 9. 3 Management review 10. 3 Continual improvement 7. 4 Communication 4. 4 QMS ISO/TC 176/SC 2/ N 1282 7. 5 Documented information 11 Date: 11

The common structure and ISO 9001: 2015 additions 8 Operation ISO/TC 176/SC 2/ N 1282 8. 1 Operational planning and control 12 Date: 12

Plan 4 Context of organization 4. 1 Understanding context 4. 2 Interested parties 4. 3 Scope 4. 4 QMS Check Act 10 Improvement 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 5. 1 Leadership and commitment 6. 1 Actions to address risks and opportunities 7. 1 Resources 8. 1 Operational planning and control 9. 1 Monitoring, measurement, analysis and evaluation 5. 2 Policy 5. 3 Organizational roles, responsibilities and authorities 7. 1. 2 People 6. 2 Quality objectives and planning 7. 1. 3 Infrastructure 6. 3 Planning of changes 7. 1. 4 Environment for the operation of processes 7. 1. 5 Monitoring and measuring resources ISO/TC 176/SC 2/ N 1282 Do 7. 1. 6 Organizational knowledge See next slide 9. 1. 2 Customer satisfaction 9. 1. 3 Analysis and evaluation 10. 1 General 10. 2 Nonconformity and corrective action 10. 3 Continual improvement 9. 2 Internal audit 9. 3 Management review 7. 2 Competence 7. 3 Awareness 7. 4 Communication 7. 5 Documented information 13 Date: 13

4 Context of organization 4. 1 Understanding context Clause 4. 1 Determine what the relevant external and internal issues are for your organization, and that are relevant to its strategic direction 4. 2 Interested parties 4. 3 Scope ISO/TC 176/SC 2/ N 1282 4. 4 QMS 14 Date: 14

4 Context of organization Clause 4. 2 Identify the relevant interested parties and their relevant requirements 4. 1 Understanding context 4. 2 Interested parties 4. 3 Scope ISO/TC 176/SC 2/ N 1282 4. 4 QMS 15 Date: 15

4 Context of organization 4. 1 Understanding context 4. 2 Interested parties 4. 3 Scope ISO/TC 176/SC 2/ N 1282 4. 4 QMS Clause 4. 3 and 4. 4 The requirement for the scope is now better defined, must be documented and consider: § external and internal issues § requirements of relevant interested parties § the products and services covered (must also be stated in scope) § allowing applicability of specific requirements § justification for any case where a requirement cannot be applied (exclusion) 16 Date: 16

4 Context of organization 4. 1 Understanding context 4. 2 Interested parties 4. 3 Scope 4. 4 QMS 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 5. 1 Leadership and commitment 6. 1 Actions to address risks and opportunities 7. 1 Resources 8. 1 Operational planning and control 9. 1 Monitoring, measurement, analysis and evaluation 5. 2 Policy 5. 3 Organizational roles, responsibilities and authorities 7. 1. 2 People 6. 2 Objectives and planning 7. 1. 3 Infrastructure 6. 3 Planning of changes 7. 1. 4 Environment for the operation of processes ISO/TC 176/SC 2/ N 1282 7. 1. 5 Monitoring and measuring resources 7. 1. 6 Organizational knowledge See next slide 9. 1. 2 Customer satisfaction 9. 1. 3 Analysis and evaluation 10 Improvement 10. 1 General 10. 2 Nonconformity and corrective action 10. 3 Continual improvement 9. 2 Internal audit 9. 3 Management review 7. 2 Competence 7. 3 Awareness 7. 4 Communication 7. 5 Documented information 17 Date: 17

5 Leadership 5. 1 Leadership and commitment 5. 2 Policy ISO/TC 176/SC 2/ N 1282 5. 3 Organizational roles, responsibilities and authorities Clause 5. 1. 1 Leadership is required to ensure: § take accountability for the effectiveness of the quality management system § ensure the quality policy and quality objectives are compatible with the context and strategic direction of the organization § ensure the integration of the QMS requirements into the organization’s business processes § promote the use of the process approach and risk-based thinking § ensure that the QMS achieves its intended results § engage, direct and support persons to contribute to the effectiveness of the QMS § supporting relevant management roles § promotion of improvement Clause 5. 1. 2 Top management needs to ensure customer satisfaction through: § customer and applicable statutory and regulatory requirements being determined and met § risk and opportunities are being addressed § the focus on products and services meeting customers and 18 other requirements Date: 18

5 Leadership Clause 5. 2 Explicit requirement to apply the policy 5. 1 Leadership and commitment 5. 2 Policy ISO/TC 176/SC 2/ N 1282 5. 3 Organizational roles, responsibilities and authorities 19 Date: 19

5 Leadership 5. 1 Leadership and commitment 5. 2 Policy ISO/TC 176/SC 2/ N 1282 5. 3 Organizational roles, responsibilities and authorities Clause 5. 2 § Explicit requirement to apply the policy Clause 5. 3 § Explicit requirement for relevant roles to be assigned, communicated and understood § No requirement for a specific management representative and the responsibility now resides with top management to assign and manage § Requirement for defining responsibility and authority for ensuring processes are delivering their intended outputs 20 Date: 20

4 Context of organization 4. 1 Understanding context 4. 2 Interested parties 4. 3 Scope 4. 4 QMS 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 5. 1 Leadership and commitment 6. 1 Actions to address risks and opportunities 7. 1 Resources 8. 1 Operational planning and control 9. 1 Monitoring, measurement, analysis and evaluation 5. 2 Policy 5. 3 Organizational roles, responsibilities and authorities 7. 1. 2 People 6. 2 Quality objectives and planning 7. 1. 3 Infrastructure 6. 3 Planning of changes 7. 1. 4 Environment for the operation of processes ISO/TC 176/SC 2/ N 1282 7. 1. 5 Monitoring and measuring resources 7. 1. 6 Organizational knowledge See next slide 9. 1. 2 Customer satisfaction 9. 1. 3 Analysis and evaluation 10 Improvement 10. 1 General 10. 2 Nonconformity and corrective action 10. 3 Continual improvement 9. 2 Internal audit 9. 3 Management review 7. 2 Competence 7. 3 Awareness 7. 4 Communication 7. 5 Documented information 21 Date: 21

6 Planning 6. 1 Actions to address risks and opportunities 6. 2 Objectives and planning Clause 6. 1 § Considering the issues raised and relevant interested parties’ requirements identified (4. 1 and 4. 2), this clause requires the determination of risks and opportunities which need to be addressed, actions to be taken and evaluation of the effectiveness of these actions ISO/TC 176/SC 2/ N 1282 6. 3 Planning of changes 22 Date: 22

6 Planning Clause 6. 2 Objectives should be: 6. 1 Actions to address risks and opportunities 6. 2 Objectives and planning § established for processes relevant to the QMS § in line with customer requirements § in line with products and services conformity ISO/TC 176/SC 2/ N 1282 6. 3 Planning of changes § monitored, communicated & updated 23 Date: 23

6 Planning 6. 1 Actions to address risk and opportunity 6. 2 Objectives and planning 6. 3 Planning of changes Clause 6. 3 §Changes to the QMS should be carried out in a planned manner §The standard has evolved to enable organizations to adapt to changing environments or circumstances Note: It is important to know that change is addressed in the following clauses: § Clause 6. 3 - Planning/implementing changes to the QMS ISO/TC 176/SC 2/ N 1282 § Clause 7. 1. 6 - Organizational knowledge - for addressing changing needs and trends, with respect to knowledge § Clause 8. 1 - Controlling operational changes, planned and unintentional § Clause 8. 5. 6 - Addressing changes affecting products & services 24 Date: 24

4 Context of organization 4. 1 Understanding context 4. 2 Interested parties 4. 3 Scope 4. 4 QMS 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 5. 1 Leadership and commitment 6. 1 Actions to address risks and opportunities 7. 1 Resources 8. 1 Operational planning and control 9. 1 Monitoring, measurement, analysis and evaluation 5. 2 Policy 5. 3 Organizational roles, responsibilities and authorities 7. 1. 2 People 6. 2 Objectives and planning 7. 1. 3 Infrastructure 6. 3 Planning of changes 7. 1. 4 Environment for the operation of processes ISO/TC 176/SC 2/ N 1282 7. 1. 5 Monitoring and measuring resources 7. 1. 6 Organizational knowledge See next slide 9. 1. 2 Customer satisfaction 9. 1. 3 Analysis and evaluation 10 Improvement 10. 1 General 10. 2 Nonconformity and corrective action 10. 3 Continual improvement 9. 2 Internal audit 9. 3 Management review 7. 2 Competence 7. 3 Awareness 7. 4 Communication 7. 5 Documented information 25 Date: 25

7 Support 7. 1 Resources 7. 1. 2 People 7. 1. 3 Infrastructure 7. 1. 4 Environment for the operation of processes ISO/TC 176/SC 2/ N 1282 7. 1. 5 Monitoring and measuring resources 7. 1. 6 Organizational knowledge Clause 7. 1 There should be adequate resources to ensure effectiveness of the QMS. Resource considerations now include: § internal resources § external providers § people § monitoring and measuring resources § organizational knowledge required to ensure the processes provide conforming products and services § external communication 7. 2 Competence 7. 3 Awareness 7. 4 Communication . 7. 5 Documented information 26 Date: 26

7 Support 7. 1 Resources 7. 1. 2 People Clause 7. 3 and 7. 4 Relevant persons doing work under the organization’s control need to have awareness and communication (internal and external) of the QMS and benefits of improving performance 7. 1. 3 Infrastructure 7. 1. 4 Environment for the operation of processes ISO/TC 176/SC 2/ N 1282 7. 1. 5 Monitoring and measuring resources 7. 1. 6 Organizational knowledge 7. 2 Competence 7. 3 Awareness 7. 4 Communication 7. 5 Documented information 27 Date: 27

7 Support 7. 1 Resources 7. 1. 2 People 7. 1. 3 Infrastructure 7. 1. 4 Environment for operation of processes ISO/TC 176/SC 2/ N 1282 7. 1. 5 Monitoring and measuring resources 7. 1. 6 Organizational knowledge 7. 2 Competence 7. 3 Awareness Clause 7. 5. 1 Requirements that used to be required for a quality manual have been enhanced and made more flexible to allow for the use of documented information needed for the quality management system Clause 7. 5. 2 Enhanced requirement for the creation and updating of documented information, e. g. description, format & suitability Clause 7. 5. 3 Control of documented information – now explicitly includes confidentiality, integrity and access 7. 4 Communication 7. 5 Documented information 28 Date: 28

4 Context of organization 4. 1 Understanding context 4. 2 Interested parties 4. 3 Scope 4. 4 QMS 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 5. 1 Leadership and commitment 6. 1 Actions to address risks and opportunities 7. 1 Resources 8. 1 Operational planning and control 9. 1 Monitoring, measurement, analysis and evaluation 5. 2 Policy 5. 3 Organizational roles, responsibilities and authorities 7. 1. 2 People 6. 2 Objectives and planning 7. 1. 3 Infrastructure 6. 3 Planning of changes 7. 1. 4 Environment for operation of processes ISO/TC 176/SC 2/ N 1282 7. 1. 5 Monitoring and measuring resources 7. 1. 6 Organizational knowledge See next slide 9. 1. 2 Customer satisfaction 9. 1. 3 Analysis and evaluation 10 Improvement 10. 1 General 10. 2 Nonconformity and corrective action 10. 3 Continual improvement 9. 2 Internal audit 9. 3 Management review 7. 2 Competence 7. 3 Awareness 7. 4 Communication 7. 5 Documented information 29 Date: 29

ISO/TC 176/SC 2/ N 1282 4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 8. 1 Operational planning and control 8. 3 Design and development of products and services 8. 4 Control of externally provided processes, products and services 8. 5 Production and service provision 8. 2 Requirements for products and services 8. 3. 1 General 8. 4. 1 General 8. 5. 1 Control of production and service provision 8. 2. 1 Customer communication 8. 3. 2 Design and development planning 8. 4. 2 Type and extent of control 8. 5. 2 Identification and traceability 8. 2. 2 Determination of requirements related to products and services 8. 3. 3 Design and development Inputs 8. 4. 3 Information for external providers 8. 5. 3 Property belonging to customers or external providers 8. 2. 3 Review of requirements related to products and services 8. 3. 4 Design and development controls 8. 2. 4 Changes to requirements for products and services 8. 3. 5 Design and development outputs 8. 3. 6 Design and development changes 10 Improvement 8. 6 Release of products and services 8. 7 Control of nonconforming process outputs 8. 5. 4 Preservation 8. 5. 5 Post-delivery activities 8. 5. 6 Control of changes 30 Date: 30

8 Operation Clause 8. 1. b § explicit requirement for establishing criteria for processes 8. 1 Operational planning and control 8. 2 Requirements for products and services 8. 2. 1 Customer communication ISO/TC 176/SC 2/ N 1282 8. 2. 2 Determination of requirements related to products and services 8. 2. 3 Review of requirements related to products and services Clause 8. 2. 1 § explicit considerations are now linked to: customer communications; customer property, and contingency actions Clause 8. 2. 2 § Determination of requirements; this requires a process and is explicit with regard to substantiating claims for products and services being offered 8. 2. 4 Changes to requirements for products and services 31 Date: 31

8 Operation Clause 8. 3 This section on design and development of products and services has substantively changed and simplified: 8. 3 Design and development of products and services 8. 3. 1 General 8. 3. 2 Design and development planning 8. 3. 3 Design and development inputs ISO/TC 176/SC 2/ N 1282 8. 3. 4 Design and development controls 8. 3. 5 Design and development outputs 8. 3. 6 Design and development changes Clause 8. 3. 2 § Design and development has been restructured to allow for a more process orientated approach § Involvement of customers and users as part of design planning to be considered Clause 8. 3. 3 § Design and development inputs – explicit requirements for internal and external resource needs, potential consequences of failure, level of control expected by customers Clause 8. 3. 4 § Design and development controls – new clause combining Reviews, Verification & Validation 32 Date: 32

8 Operation 8. 4 Control of externally provided processes products and services Clause 8. 4 § The terms which previously referred to purchasing and ‘outsourcing’ is now ‘Control of externally provided processes, products and services’ Clause 8. 4. 1 General 8. 4. 2 Type and extent of control 8. 4. 3 Information for external providers § Conditions are applied when controls are required for externally provided processes, products and service § Terminology has changed from ‘supplier’ to ‘external provider’ ISO/TC 176/SC 2/ N 1282 Clause 8. 4. 2 § Type and extent of control of external provision previous notes in 4. 1 (ISO 9001: 2008) now turned into requirements Clause 8. 4. 3 § Information for external providers are now more detailed and explicit 33 Date: 33

8 Operation Clause 8. 5. 1 This clause specifically considers: 8. 5 Production and service provision 8. 5. 1 Control of production and service provision 8. 5. 2 Identification and traceability 8. 5. 3 Property belonging to customers or external providers ISO/TC 176/SC 2/ N 1282 8. 5. 4 Preservation § monitoring and measurement activities will ensure the control of processes and output (clauses 8. 2. 3 and 8. 2. 4 of ISO 9001: 2008 have been moved to 8. 5. 1) § acceptance criteria for products and services are met § the use, and control of suitable infrastructure and process environment § suitable monitoring and measuring resources § Requires competent persons 8. 5. 5 Post-delivery activities 8. 5. 6 Control of changes 34 Date: 34

8 Operation 8. 5 Production and service provision 8. 5. 1 Control of production and service provision 8. 5. 2 Identification and traceability 8. 5. 3 Property belonging to customers or external providers ISO/TC 176/SC 2/ N 1282 8. 5. 4 Preservation 8. 5. 5 Post-delivery activities 8. 5. 6 Control of changes Clause 8. 5. 2 § The identification and traceability now focus on ‘outputs’ rather than on ‘product’ (includes intermediate products and services) rather than on ‘product’ Clause 8. 5. 3 § Customer property has been expanded to include external providers’ property Clause 8. 5. 4 § Preservation of product has been changed to preservation of the output Clause 8. 5. 5 § Post-delivery activities is a new clause Clause 8. 5. 6 § A new requirement for the control of changes is addressed in the slide introducing the concept of change 35 Date: 35

8 Operation Clause 8. 6 § The release of products and services is now part of the operational requirements 8. 6 Release of products and services 8. 7 Control of nonconforming outputs Clause 8. 7 § The control of nonconforming output is more explicit; it now considers the options to apply correction and corrective action ISO/TC 176/SC 2/ N 1282 § Nonconforming product changed to nonconforming output 36 Date: 36

4 Context of organization 4. 1 Understanding context 4. 2 Interested parties 4. 3 Scope 4. 4 QMS 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance evaluation 5. 1 Leadership and commitment 6. 1 Actions to address risks and opportunities 7. 1 Resources 8. 1 Operational planning and control 9. 1 Monitoring, measurement, analysis and evaluation 5. 2 Policy 5. 3 Organizational roles, responsibilities and authorities 7. 1. 2 People 6. 2 Quality objectives and planning 7. 1. 3 Infrastructure 6. 3 Planning of changes 7. 1. 4 Environment for the operation of processes ISO/TC 176/SC 2/ N 1282 7. 1. 5 Monitoring and measuring resources 7. 1. 6 Organizational knowledge See next slide 9. 1. 2 Customer satisfaction 9. 1. 3 Analysis and evaluation 10 Improvement 10. 1 General 10. 2 Nonconformity and corrective action 10. 3 Continual improvement 9. 2 Internal audit 9. 3 Management review 7. 2 Competence 7. 3 Awareness 7. 4 Communication 7. 5 Documented information 37 Date: 37

9 Performance evaluation 9. 1 Monitoring, measurement, analysis and evaluation 9. 1. 1 General 9. 1. 2 Customer satisfaction ISO/TC 176/SC 2/ N 1282 9. 1. 3 Analysis and evaluation 9. 2 Internal audit Clause 9. 1. 1 § In 8. 1 ISO 9001: 2008 (clause 8. 1) there was a requirement for planning. This is replaced with identifying what needs monitoring and measuring, and the methods to be used Clause 9. 1. 3 § There are specific requirements for analysis and evaluation when using results as inputs to management review § Effective implementation of planning and actions to address risks and opportunities are new requirements in this clause 9. 3 Management review 38 Date: 38

9 Performance Evaluation 9. 1 Monitoring, measurement, analysis and evaluation 9. 1. 2 Customer satisfaction 9. 1. 3 Analysis and evaluation ISO/TC 176/SC 2/ N 1282 9. 2 Internal audit 9. 3 Management review 9. 3. 1 General 9. 3. 2 Management review input 9. 3. 3 Management review output Clause 9. 2 § Internal audit program now has explicit considerations for: quality objectives, customer feedback and changes impacting the organization; management responsibility for action is now implicit whereas previously this was explicit § An auditor is now required to be impartial versus in the previous version they could not audit their own work Clause 9. 3 § There are now additional requirements for management review. These include: § changes in external and internal issues (such as strategic direction) § performance concerning external providers § adequacy of resources for effective QMS and effectiveness of actions taken addressing risks & opportunities Clause 9. 3. 1 § Management reviews should be aligned to the strategic direction of the organization Clause 9. 3. 3 § Management review outputs have been enhanced to include many of the new areas of focus 39 Date: 39

4 Context of organization 4. 1 Understanding context 4. 2 Interested parties 4. 3 Scope 4. 4 QMS 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance Evaluation 5. 1 Leadership and commitment 6. 1 Actions to address risks and opportunities 7. 1 Resources 8. 1 Operational planning and control 9. 1 Monitoring, measurement, analysis and evaluation See next slide 9. 1. 2 Customer satisfaction 10. 2 Nonconformity and corrective action 9. 1. 3 Analysis and evaluation 10. 3 Continual improvement 5. 2 Policy 5. 3 Organizational roles, responsibilities and authorities 7. 1. 2 People 6. 2 Objectives and planning 7. 1. 3 Infrastructure 6. 3 Planning of changes 7. 1. 4 Environment for the operation of processes ISO/TC 176/SC 2/ N 1282 7. 1. 5 Monitoring and measuring resources 7. 1. 6 Organizational knowledge 10 Improvement 10. 1 General 9. 2 Internal audit 9. 3 Management review 7. 2 Competence 7. 3 Awareness 7. 4 Communication 7. 5 Documented information 40 Date: 40

10 Improvement 10. 1 General 10. 2 Nonconformity and corrective action ISO/TC 176/SC 2/ N 1282 10. 3 Continual improvement Clause 10. 1 § This clause is new, it addresses more comprehensive opportunities for improvement; not only continual improvement § Addresses improvement of products and services and future needs and expectations § Emphasis is now on improving processes to prevent nonconformities and improving products and services Clause 10. 2 § The nonconformity referred to in this clause concerns the entire QMS and not specifically the products or services which are addressed under clause 8. 7 Clause 10. 2. 1 § New emphasis is placed on nonconformity and corrective action § Consequences are now included thus actions taken now recognize the potential occurrence of a similar nonconformity elsewhere § Risks and opportunities now need to be updated when required following a nonconformity Clause 10. 2. 2 § Documented information is now required on the nature of the nonconformity and subsequent actions taken Clause 10. 3 § Opportunities shall be addressed as part of continual improvement 41 Date: 41

Summary § Determining the organizational context enables a more effective implementation of the quality management system § Greater emphasis on processes being managed to achieve planned results § Alignment with strategic direction § Integration of the QMS into organization’s business processes ISO/TC 176/SC 2/ N 1282 § Determining risks and opportunities increase the effectiveness of the organization’s QMS § Change management has been expanded to add emphasis that the QMS should be carried out in a planned manner § The concept of organizational knowledge introduced to ensure the organization acquires and maintains the necessary knowledge § Communication expanded to include external 42 Date: 42

ISO 9001: 2015 Certification Transition Timeline 2015 2016 2017 2018 ISO/TC 176/SC 2/ N 1282 September 2015 Published International Standard September 2015 start of 3 years transition period to September 2018 Certifications to ISO 9001: 2008 will no longer be valid after September 2018 43 Date: 43

More information Further information is available at ISO/TC 176/SC 2/ N 1282 www. iso. org/tc 176/sc 02/public 44 Date: 44