iso 9001:2015 just around the corner asq ottawa chapter – june 30, 2015

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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Contact Information

Jim Moran:jim@simplifyISO.com

Thank You for Participating!

Transition to ISO 9001:2015