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CQI & IRCA WEBINAR
July 12 2004
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 - 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 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.
5.
6.
7.
8.
9.
10.
Context of the organisation
Leadership
Planning
Support
Operation
Performance evaluation
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
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
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.
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
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
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
Definitions
Interested party
3.02 - person or organisation (3.01)
that can affect, be affected by, or
perceive themselves to be affected by a
decision or activity.
Parties
All parties
Parties
All parties
Interested parties
Parties
All parties
Interested 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
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
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).
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
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
6 Planning for the QMS
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
5.3 Organizational roles, responsibilities and
authorities
7.4 Communication
9.3 Management review
Possible* ISO 9001:2015
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
Top management
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.
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 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
6 Planning for the QMS
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
5.3 Organizational roles, responsibilities and
authorities
7.4 Communication
9.3 Management review
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
Definitions
Risk
3.09 – effect of uncertainty
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, 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.
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
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
6 Planning for the QMS
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
5.3 Organizational roles, responsibilities and
authorities
7.4 Communication
9.3 Management review
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
Possible* ISO 9001:2015
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 the
products and services
8.2.3 Review of the customer requirements
Possible* ISO 9001:2015
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 services
8.5.1
8.5.2
8.5.3
8.5.4
8.5.5
8.5.6
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
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
8.3 Control of nonconforming product
8.4 Analysis of data
9.2 Internal audit
9.3 Management review
8.7 Control of nonconforming process outputs,
products and services
9.1 Monitoring, measurement, analysis and evaluation
9.1 Monitoring, measurement, analysis and evaluation
10 Improvement
8.5 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
© Copyright CQI 2014
Chartered Quality Institute
2nd Floor North
Chancery Exchange
10 Furnival Street
London EC4A 1AB
Email: [email protected]
Tel: +44 (0)20 7245 6833
Fax: +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]