IRCA and CQI Webinar Slides

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CQI & IRCA WEBINAR

June 20 2014



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.



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 - qualityprofessionals, 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 14001 is expected to be published about the same time



Drivers for change

• Evolution of the ‘business environment’

• Evolution of management systems

• Evolution of quality

• ISO scheduled review



Timeline

2014 (DIS Ballot)

2015 (FDIS Ballot)



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)



Annex SL (High-level structure)

Introduction

1. Scope

2. Normative references

3. Terms and definitions

Appendix

Bibliography

4. Context of the organisation

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement



Comparison (1 of 5)

ISO 9001:2008 ISO DIS 9001:2015

0 Introduction 0 Introduction

1 Scope 1 Scope

2 Normative references 2 Normative references

3 Terms and definitions 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



Possible* ISO 9001:2015




interested parties

4.3 Determining the scope of the quality

management system

4.4 Quality management system and its

processes



Definitions

3.01 – person or group of people that

has its own functions with responsibilities,

authorities and relationships to achieveits 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.

Organisations







interested parties

4.3 Determining the scope of the qualitymanagement system


processes



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







interested parties

4.3 Determining the scope of the qualitymanagement system


processes



Definitions

3.02 - person or organisation (3.01)

that can affect, be affected by, or

perceive themselves to be affected by adecision or activity.

Interested party



Parties

All parties



Parties

Interested parties

All parties



Parties

Interested parties

All parties

Relevant Interested parties



Parties

All parties

Interested parties

Relevant Interested parties

Relevant Interested Parties

Relevant Requirements



Comparison (1 of 5)

ISO 9001:2008 ISO DIS 9001:2015


1 Scope 1 Scope



4 Quality management system 4 Context of the organization 4.1 Understanding the organization and its context


interested parties


system





Definitions

3.11 – information required to be

controlled and maintained by an

organization (3.01) and the medium onwhich 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).

Documented information



Comparison (1 of 5)

ISO 9001:2008 ISO DIS 9001:2015


1 Scope 1 Scope



4 Quality management system 4 Context of the organization 4.1 Understanding the organization and its context


interested parties


system





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 QMS6.1 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




5. Leadership

5.1 Leadership and commitment

5.1.1 Leadership and commitment to the quality

management system

5.1.2 Customer focus

5.2 Quality policy

5.3 Organisation roles, responsibilities and

authorities



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;



Definitions

3.05 - 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.

Top management



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?



Comparison (2 of 5)

ISO 9001:2008 ISO DIS 9001:2015





5.4 Planning






authorities

7.4 Communication





6. Planning for the quality managementsystem

6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve

them




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 orknowledge of, an event, its consequence, or likelihood.

Note 3 to entry: Risk is often characterized by reference to potential events (ISO Guide 73, 3.5.1.3) and

consequences (ISO Guide 73, 3.6.1.3), 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, 3.6.1.1) of occurrence.




6. Planning for the quality managementsystem

6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve

them




Comparison (2 of 5)

ISO 9001:2008 ISO DIS 9001:2015





5.4 Planning






authorities

7.4 Communication




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



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




8. Operation

8.1 Operation planning and control

8.2 Determination of customer requirements

8.2.1 Customer communication

8.2.2 Review of requirements related to theproducts and services

8.2.3 Review of the customer requirements




8. Operation

8.4 Control of externally provided products and services

8.4.1 General

8.4.2 Type and extent of control of external provision

8.4.3 Documented information for external providers

8.5 Realisation and provision of products and of services8.5.1 Control of the realization and provision of products and services

8.5.2 Identification and traceability

8.5.3 Property belonging to customers or external providers

8.5.4 Preservation

8.5.5 Post delivery activities

8.5.6 Control of changes



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



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

9.1 Monitoring, measurement, analysis and evaluation

8.4 Analysis of data 9.1 Monitoring, measurement, analysis and evaluation

8.5 Improvement

10 Improvement 10.1 General

10.2 Nonconformity and corrective action

10.3 Continual improvement



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!



Thank you



© 2014 Duncan MacNee Limited & The CQI.

2nd Floor North

Chancery Exchange

10 Furnival Street

London EC4A 1AB

Email: [email protected]

Tel: +44 (0)20 7245 6833Fax: +44 (0)20 7245 6755

If you wish to reproduce any of this presentation, please contact

Neil Everett, IRCA Business Development Manager at [email protected]

mailto:[email protected]

mailto:[email protected]

IRCA and CQI Webinar Slides

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