1. CQI & IRCA WEBINAR
July

2. Purpose
To provide CQI and IRCA members with an update on the contents of the Draft International Standard (DIS)
To advise CQI and IRCA members on how they can provide comment on the DIS if they believe changes are required.

3. Key Messages
ISO 9001 is the world’s most adopted management system standard
It is currently being revised with the new edition scheduled for publication in September 2015
Although it is still not finalised, we already know much of what it will contain
The changes will be significant for all sizes of business - quality professionals, audit professionals, senior management
These groups need to begin assessing the impacts of the changes now
Because CQI is a Category A Liaison to ISO/TC 176 there is an opportunity to provide input on the Draft International Standard
ISO is expected to be published about the same time

4. Drivers for change Evolution of the ‘business environment’
Evolution of management systems
Evolution of quality
ISO scheduled review

5. Timeline
2014 (DIS Ballot)
2015 (FDIS Ballot)

6. What we know so far Adoption of Annex SL High-level structure
Identical core text
Common terms and core definitions
ISO 9001:2008 text
Changes made for the Committee Draft (CD)
Changes made for the Draft International Standard (DIS)

7. Annex SL (High-level structure)
Introduction
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organisation
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
Appendix
Bibliography

8. Comparison (1 of 5) ISO 9001:2008 ISO DIS 9001:2015 0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
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
4.1 General requirements
4.4 Quality management system and its processes
4.2 Documentation requirements
7.5 Documented information

9. Possible* ISO 9001:2015 4. Context of the organisation
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

10. Definitions
Orginisations
3.01 – person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives (3.08)
Note 1 to entry: The concept of organization includes, but is not limited to sole-trader, company, corporation, firm, enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated or not, public or private.

11. Possible* ISO 9001:2015 4. Context of the organisation
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

12. Organisational context
Purpose: Clothing manufacturer
Intended outcome: Production of men’s 3 piece suits
Internal issues
Automation
Workforce
Design secrets
Capacity
Company culture
Innovation
External issues
Customers
Fashion
New markets
Deadlines
Competition
Regulators
Utilities
(Relevant) interested parties
Consumers
Employees
Owners/shareholders
Society
Suppliers and partners

13. Possible* ISO 9001:2015 4. Context of the organisation
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

14. Definitions
Interested party
person or organisation (3.01) that can affect, be affected by, or perceive themselves to be affected by a decision or activity.

15. Parties
All parties

16. Parties
All parties
Interested parties

17. Parties
All parties
Interested parties
Relevant Interested parties

18. Parties All parties Interested parties Relevant Interested parties
Relevant Requirements

19. Comparison (1 of 5) ISO 9001:2008 ISO DIS 9001:2015 0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
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
4.1 General requirements
4.4 Quality management system and its processes
4.2 Documentation requirements
7.5 Documented information

20. Definitions
Documented information
3.11 – information required to be controlled and maintained by an organization (3.01) and the medium on which it is contained.
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to:
the management system (3.04), including related processes (3.12);
information created in order for the organization to operate (documentation);
evidence of results achieved (records).

21. Comparison (1 of 5) ISO 9001:2008 ISO DIS 9001:2015 0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
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
4.1 General requirements
4.4 Quality management system and its processes
4.2 Documentation requirements
7.5 Documented information

22. Comparison (2 of 5) ISO 9001:2008 ISO DIS 9001:2015
5 Management responsibility
5 Leadership
5.1 Management commitment
5.1 Leadership and commitment
5.2 Customer focus
5.1.2 Customer focus
5.3 Quality policy
5.2 Quality policy
5.4 Planning
6 Planning for the QMS
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
5.5 Responsibility, authority and communication
5.3 Organizational roles, responsibilities and authorities
7.4 Communication
5.6 Management review
9.3 Management review

23. Possible* ISO 9001:2015 5. Leadership 5.1 Leadership and commitment
Leadership and commitment to the quality
management system
Customer focus
5.2 Quality policy
5.3 Organisation roles, responsibilities and
authorities

24. Leadership changes 5.1 Leadership and commitment
Top management shall demonstrate leadership and commitment …by:
Ensuring (i.e. someone else can do it)
the quality policy and quality objectives are established for the quality management system and are compatible with the strategic direction and the context of the organization;
the quality policy is communicated, understood and applied within the organization;
integration of the quality management system requirements into the organization’s business processes;
the resources needed for the quality management system are available;
the quality management system achieves its intended results;
Doing (i.e. they must do it themselves)
taking accountability of the effectiveness of the quality management system;
promoting awareness of the process approach;
communicating the importance of effective quality management and of conforming to the quality management system requirements;
engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;
promoting continual improvement and innovation;
supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility;

25. Definitions
Top management
person or group of people who directs and controls an organization (3.01) at the highest level.
Note 1: Top management has the power to delegate authority and provide resources within the organization.
Note 2: If the scope of the management system (3.04) covers only part of an organization then top management refers to those who direct and control that part of the organization.

26. Implications of Leadership and commitment for:
Organisations - internal audit must include top management
Implementers - helping top management provide objective evidence of
compliance; changing meeting agendas/minutes,
creating/updating communication channels/methods
Quality professionals - making top management aware of their responsibilities;
communicating, coaching, training
Top management - being audited as a matter of routine. ‘Do’ not ‘delegate’.
Auditors - auditing top management (as opposed to the management
representative) is now compulsory.
What objective evidence would an auditor seek to demonstrate
conformance?
Will an auditor need new personal skills to deal with top management?

27. Comparison (2 of 5) ISO 9001:2008 ISO DIS 9001:2015
5 Management responsibility
5 Leadership
5.1 Management commitment
5.1 Leadership and commitment
5.2 Customer focus
5.1.2 Customer focus
5.3 Quality policy
5.2 Quality policy
5.4 Planning
6 Planning for the QMS
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
5.5 Responsibility, authority and communication
5.3 Organizational roles, responsibilities and authorities
7.4 Communication
5.6 Management review
9.3 Management review

28. Possible* ISO 9001:2015 6. Planning for the quality management system
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve
them
6.3 Planning of changes

29. Definitions 3.09 – effect of uncertainty Risk
Note 1 to entry: An effect is a deviation from the expected — positive or negative.
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or knowledge of, an event, its consequence, or likelihood.
Note 3 to entry: Risk is often characterized by reference to potential events (ISO Guide 73, ) and consequences (ISO Guide 73, ), or a combination of these.
Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes in circumstances) and the associated likelihood (ISO Guide 73, ) of occurrence.

30. Possible* ISO 9001:2015 6. Planning for the quality management system
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve
them
6.3 Planning of changes

31. Comparison (2 of 5) ISO 9001:2008 ISO DIS 9001:2015
5 Management responsibility
5 Leadership
5.1 Management commitment
5.1 Leadership and commitment
5.2 Customer focus
5.1.2 Customer focus
5.3 Quality policy
5.2 Quality policy
5.4 Planning
6 Planning for the QMS
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
5.5 Responsibility, authority and communication
5.3 Organizational roles, responsibilities and authorities
7.4 Communication
5.6 Management review
9.3 Management review

32. Comparison (3 of 5) ISO 9001:2008 ISO DIS 9001:2015
6 Resource management
7 Support
6.1 Provision of resources
7.1 Resources
6.2 Human resources
7.2 Competence
7.3 Awareness
7.4 Communication
6.3 Infrastructure
7.1.3 Infrastructure
6.4 Work environment
7.1.4 Environment for the operation of processes

33. Comparison (4 of 5) ISO 9001:2008 ISO DIS 9001:2015
7 Product realization
8 Operation
7.1 Planning of product realization
8.1 Operational planning and control
7.2 Customer-related processes
8.2 Determination of requirements
for products and services
7.3 Design and development
8.3 Design and Development of products and services
7.4 Purchasing
8.4 Control of externally provided products and services
7.5 Production and service provision
8.5 Production and service provision
7.6 Control of monitoring and measuring equipment
7.1.5 Monitoring and measuring resources
8.6 Release of products and services

34. Possible* ISO 9001:2015 8. Operation
8.1 Operation planning and control
8.2 Determination of customer requirements
Customer communication
Review of requirements related to the
products and services
Review of the customer requirements

35. Possible* ISO 9001:2015 8. Operation
8.4 Control of externally provided products and services
General
Type and extent of control of external provision
Documented information for external providers
8.5 Realisation and provision of products and of services
Control of the realization and provision of products and services
Identification and traceability
Property belonging to customers or external providers
Preservation
Post delivery activities
Control of changes

36. Comparison (4 of 5) ISO 9001:2008 ISO DIS 9001:2015
7 Product realization
8 Operation
7.1 Planning of product realization
8.1 Operational planning and control
7.2 Customer-related processes
8.2 Determination of requirements
for products and services
7.3 Design and development
8.3 Design and Development of products and services
7.4 Purchasing
8.4 Control of externally provided products and services
7.5 Production and service provision
8.5 Production and service provision
7.6 Control of monitoring and measuring equipment
7.1.5 Monitoring and measuring resources
8.6 Release of products and services

37. Comparison (5 of 5) ISO 9001:2008 ISO DIS 9001:2015
8 Measurement, analysis and improvement
9 Performance evaluation
8.1 General
9.1 Monitoring, measurement, analysis and evaluation
8.2 Monitoring and measurement
9.2 Internal audit
9.3 Management review
8.3 Control of nonconforming product
8.7 Control of nonconforming process outputs, products and services
8.4 Analysis of data
8.5 Improvement
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement

38. What should you be doing next?
Increase awareness and understanding of the changes and communicate and educate within their organisation
Regularly check CQI/IRCA websites
for
- Schedule
- Articles
- Opinion pieces
- Hints and tips
Need to make changes
- System and people
You should start now!

39. Thank you

40. © Copyright CQI 2014 Chartered Quality Institute 2nd Floor North Chancery Exchange 10 Furnival Street London EC4A 1AB Tel: +44 (0) Fax: +44 (0)   If you wish to reproduce any of this presentation, please contact Neil Everett, IRCA Business Development Manager at