ISO 9001:2015 DIS
16th October 2014
Mark Braham MSc, MCQI CQP
The AA, Quality Assurance Manager
The CQI, ISO9001:2015 Team Leader
Agenda
• Why now, reason for change?
• Annex SL.
• What has changed in the DIS?
• Next steps, be prepared.
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Why now?
Reason for change….
Reason for change
• Business evolution
• Quality/business management systems maturity
• Quality development - Service sectors, NHS etc.
• ISO process every 5 years
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Schedule
2014 (DIS Ballot)
Jan
Mar
Feb
May
Apr
Jul
Jun
Sep
Aug
Nov
Oct
Dec
2015 (FDIS Ballot)
Jan
Mar
Feb
May
Apr
Jul
Jun
Sep
Aug
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Nov
Oct
Dec
Annex SL
Future ISO standards
Annex SL
• What is annex SL?
• High Level Structure
• Identical Core Text
• Common Terms and Core Definitions
• We have no choice……..
• Main headings are mostly annex SL text
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ISO9001:2015
What has changed.
What has changed
1 of 5
ISO 9001:2008
ISO DIS 9001:2015
0 Introduction
0 Introduction
1 Scope Quote Goes here
2 Normative references
1 Scope
3 Terms and definitions
2 Normative references
Break
time
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
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What has changed
2 of 5
ISO 9001:2008
ISO DIS 9001:2015
5 Management responsibility
5 Leadership
5.1 Management
commitment
Quote Goes
here
5.1 Leadership and commitment
5.2 Customer focus
5.1.2 Customer focus
Break
time
5.2 Quality policy
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and
communication
5.6 Management review
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
5.3 Organizational roles, responsibilities and
authorities
7.4 Communication
9.3 Management review
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What has changed
3 of 5
ISO 9001:2008
ISO DIS 9001:2015
6 Resource management
Quote Goes here
7 Support
6.1 Provision of resources
7.1 Resources
Break 7.2
time
Competence
6.2 Human resources
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
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What has changed
4 of 5
ISO 9001:2008
ISO DIS 9001:2015
7 Product realization
Quote Goes here
7.1 Planning of product realization
8 Operation
8.1 Operational planning and control
8.2 Determination of requirements for
Break time
products and services
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
8.3 Design and Development of products
and services
8.4 Control of externally provided
products and services
8.5 Production and service provision
7.6 Control of monitoring and measuring 7.1.5 Monitoring and measuring
equipment
resources
8.6 Release of products and services
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What has changed
ISO 9001:2008
5 of 5
ISO DIS 9001:2015
8 Measurement, analysis and
improvement
Quote Goes here
8.1 General
9 Performance evaluation
9.1 Monitoring, measurement, analysis
and evaluation
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
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual Improvement
Break time
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
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Fail to prepare, prepare to fail
Next steps
Next steps
• Need to prepare
– Awareness and understanding of the changes
– Regularly check sources for data
– IAF – 3 years from publication
– Need to make changes, systems and people
– Triaster – number of process or processes = ?
Join the discussion at www.triaster.co.uk/connector
Call us on +44 (0)870 402 1234
Break time
Break time
Join the discussion at www.triaster.co.uk/connector
Call us on +44 (0)870 402 1234
Triaster Conference 2014
Coffee break!  until 15:00
Then at 11:05am:
Business Track: A roundup demonstration of the
most beneficial Triaster Solution functionality with
Carma Cooper and Victoria Glancy
Technical Track: A glimpse of the future with
Andrew Ridgeley and Chris Mawdsley
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