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ISO 9001:2015 Just around the corner
ASQ Ottawa Chapter – June 30, 2015
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Participant Objectives
What would you like to find out in the next hour?
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July 2015Draft FDIS
August 2015FDIS for
ballot
September 2015
Published
August 2014Comments
closed
May 2014DIS for
comment and ballot
The 'Structured Layer' design of the new Standard
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1.Scope2.Normative references3.Terms and definitions (0)4.Quality Management System5.Management Responsibility6.Resources7.Product Realization8.Measurement, Analysis and
Improvement
9001:2008
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1.Scope2.Normative references3.Terms and definitions (69)4.Context of the organization5.Leadership6.Planning7.Support8.Operation9.Performance evaluation10.Improvement
9001:2015 DIS
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Quality Management Principles
Were 8: Now 7:
Customer focus Customer focus
Leadership Leadership
Involvement of people Engagement of people
Process approach Process approach
System approach to management
(Included in the process approach)
Continual improvement Improvement
Factual approach to decision making
Evidence based decision making
Mutually beneficial supplier relationships
Relationship management
ISO/DIS 9001:2015 Requirements
The Clauses
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5 Leadership
6 Planning
7 Support
9 Performance Evaluation
10 Improvement
4 Context of the organization
8 Operation
productsservices
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4.1 a)-f)
4.1, 4.4.1, 4.4.2
4.24.3
You’ll want to review:4.2 – Understanding needs and
expectations of customers
4 Context of the organization
8 Operation
productsservices
2008
2015
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5.15.1.1
5.25.1.2 5.3
5.25.5.15.3
5 Leadership
8 Operation
productsservices
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Leadership, policy and responsibilities are linked in a number of ways…
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5.15.1.1
5.25.1.2
5.35.2
5.5.15.3
5 Leadership
Leadership and commitment
Customer Focus
Quality Policy
Organizational Roles, Responsibilities and Authorities
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“Leaders establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.”
ISO 9001:2015 B3 QMP2
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“Creation of unity of purpose and direction and engagement of people enable an organization to align its strategies, policies, processes and resources to achieve its objectives.”
ISO 9001:2015 B3 QMP2
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Leaders lead by example whether they want to or not
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Leaders have to demonstrate commitment…
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Discussion:
Based on what you see in the handout, how will you explain these requirements to Management at your organization?
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5.46.2
You’ll want to review:6.1 – Actions to address risks and opportunities , 6.3 – Planning of changes
6 Planning
8 Operation
productsservices
There is no requirement for a formal risk management methodology
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Exercise
1. In teams, explain how you currently identify risks – use the sticky notes provided
2. The other teams: Explain how you currently manage change (create an explanation that your team can present)
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6.37.1.3
6.2.17.1.5
6.2.27.1.2, 7.2, 7.3
5.5.37.4
4.2.17.5, 7.5.1
4.2.3/47.5.2 7.6
7.1.4
7 Support
6.47.1.4
8 Operation
productsservices
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7.18.1
7.5.1/28.5.1/2
7.2 8.2.2, 8.2.3
7.38.3.1 - 8.3.6
7.48.4.1,
8.4.2, 8.4.3
8.38.7
7.2.38.2.1
7.5.38.5.2
7.5.48.5.3
7.5.58.5.4, 8.5.5
8 Operation
productsservices
You’ll want to review:8.5.6 Control of changes
8.6 Release of…
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8.19.1.1
8.2.19.1.2
8.49.1.3
8.2.29.2
5.69.3
8.2.39.1.3 e)
8.2.49.1.3 a)
9 Performance Evaluation
8 Operation
productsservices
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Exercise
1. In teams, create a list of the kinds of processes and products and/or service delivery that you measure now.
2. Identify whether you’ll have to develop any additional measurements
3. Be ready to present your findings.
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8.5.2/310.2
8.5.110.3
10 Improvement
8 Operation
productsservices
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Improvement
Corrective Actions
Preventive Actions
ClientsInternalExternal
AuditsInternalExternal
Management Review
Metrics-measurements
ReactiveProactive
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Now that you’ve seen an overview of the changes, where do you think your organization will need to do the most work?
Exercise
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5 Leadership
6 Planning
7 Support
9 Performance Evaluation
10 Improvement
4 Context of the organization
8 Operation
productsservices
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Session Summary:
• You now understand the 'Structured Layer' design if the new Standard
• You have learned about the new requirements for Management Involvement and the Leadership requirements linked to it.
• You understand new the requirements for Risk Management and Change Management
• You understand the application of requirements to Operations• You have learned about the requirements for activities that
support Operations including Improvements• You now recognize the benefits of employee engagement and
related requirements• You have seen the link between the QMS, EMS and OHSAS
requirements• You have a framework for migrating from your existing system
to ISO 9001:2015 and you can begin any time
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Thank You for Participating!
Transition to ISO 9001:2015
