Welcome

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ISO9001:2015 Overview
Revisions & Impact
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 Joe Mansour
Lead Auditor/ISO9001:2015
Program Manager

DQS-UL Management Systems Solutions

760-458-3879 (office/cell)
[email protected]
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 www.ul-dqsusa.com

DQS-UL Management Systems Solutions

http://ul-dqsusa.com/iso-90012015/
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 Todays Presentation - ISO9001:2015

Highlight Changes since October 2014

Review Clause 0 of the Standard. Establish timeline for

three more webinars, each covering various sections of
the Standard

Overall structure of the Standard

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Provide UL DQSs transition plan for all registered clients

Provide UL DQSs Client Internal Auditor Training/

Certification Plan details.
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 Roadmap ISO 9001:2015

1987 1994 2000 2015

Initial Release:
based on
BS5750
Significant
Changes
1994: element
based - 20
sections.

2000: Radical

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Change:Process
Based

2008: Minor
Revisions
 Changes Since October 2014

Development is on track for FDIS in June/July 2015.

Standard to be published by September 2015.

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 High Level Structure

1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation

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10. Improvement
ISO 9001: Annex A-C Clarifications, Quality Management Principles, QMS family of standards; some
subclauses mandated as well.
Based on 7 Quality Management Principles

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 ISO9001:2008 vs. ISO/DIS 9001

ISO ISO ISO ISO

ISO/DIS 9001 ISO/DIS 9001 ISO/DIS 9001 ISO/DIS 9001
9001:2008 9001:2008 9001:2008 9001:2008

4 4 5.5.3 7.4 7.2.3 8.2.1 7.5.4 8.5.3

4.1 4.4 5.6 9.3 7.3 8.5 7.5.5 8.5.4

4.2 7.5 5.6.1 9.3.1 7.3.1 8.3, 8.3.1, 8.3.2 7.6 7.1.5

4.2.1 7.5.1 5.6.2 9.3.1 7.3.2 8.3.3 8 9.1

4.2.2 4.3, 7.5.1, 4.4 5.6.3 9.3.2 7.3.3 8.3.5 8.1 9.1.1

4.2.3 7.5.2, 7.5.3 6 7.1 7.3.4 8.3.4 8.2 9.1

4.2.4 7.5.2, 7.5.3 6.1 7.1.1, 7.1.2 7.3.5 8.3.4 8.2.1 9.1.2

5 5 6.2 7.2 7.3.6 8.3.4 8.2.2 9.2

5.1 5.1, 5.1.1 6.2.1 7.2 7.3.7 8.3.6 8.2.3 9.1.1

5.2 5.1.2 6.2.2 7.2 , 7.3 7.4 8.4 8.2.4 8.6

5.3 5.2 6.3 7.1.3 7.4.1 8.4.1,8.4.2 8.3 8.7

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5.4 6 6.4 7.1.4 7.4.2 8.4.3 8.4 9.1.3

5.4.1 6.2 7 8 7.4.3 8.6 8.5 10

5.4.2 6, 6.1, 6.3 7.1 8.1 7.5 8.5 8.5.1 10.1, 10.3

5.5 5 7.2 8.2 7.5.1 8.5.1, 8.5.5 8.5.2 10.2

5.5.1 5.3 7.2.1 8.2.2 7.5.2 8.5.1 8.5.3 Clause removed

5.5.2 5.3 7.2.2 8.2.3 7.5.3 8.5.2 see 6.1

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 Notable Changes

- Quality Manual

- Management Representative

- Preventive Action

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 Notable Changes

If a quality manual is currently written to reflect the ISO

9001:2008 standard, does it have to be re-written to
reflect the now 10 instead of 8 sections?

No, assuming that the Quality Manual does not provide any
contradictory information concerning the requirements of
ISO9001:2015. However, the requirements of the two
standards are significantly different. Upgrading the Quality
Manual to comply with the requirements of the new standard
may be a valuable effort to better identify the deficiencies

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within the organization and to have them addressed prior to
the upgrade audit. Renumbering of the pages and/or
sections is not essential as the new standard does not
even require that a Quality Manual be maintained.
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 Notable Changes

If a company has a manual based on standard

requirements, wont they need to update to reflect process
approach?

There is no requirement for a quality manual in the draft for

2015. The new standard also requires that the processes be
identified and that their interaction be defined. The internal
audit process must use the process approach. The process
approach requirement has not changed. However, although
the Process Approach was noted in the ISO9001:2008

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standard, the new standard explicitly requires the use of the
Process Approach when implementing the Quality
Management System.
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 Notable Changes

If a company has a manual based on standard

requirements, wont they need to update to reflect
process approach?

.. Furthermore, the new standard requires the top

management to demonstrate leadership and commitment by
promoting awareness of the Process Approach within the
organization. Since a Quality Manual is no longer required,

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the documented information required by the standard may
be in any media or format.

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 Notable Changes

- Quality Manual

- Management Representative

- Preventive Action

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 Notable Changes

You mentioned that a management representative is

not required any more. How about MRM?

Although the requirement for having a management

representative has been removed, the new standard
now allows for multiple individuals to be responsible for
different aspects of the quality management system
(Process owners, instead of just one person for the
entire system). Management is now required to identify

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the responsibility and authority of the personnel affecting
quality. Section 9.3 of the Standard clearly defines the
requirements for the Management Review Process. It is
an essential part of the PDCA cycle for performance
evaluation.
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 Notable Changes

- Quality Manual

- Management Representative

- Preventive Action

DQS-UL Management Systems Solutions

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 DQS-UL Management Systems Solutions
Notable Changes

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 Notable Changes

P-D-C-A
ISO9001:2008 Preventive
Action

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INPUT PROCESS OUTPUT

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 Notable Changes

P-D-C-A
ISO9001:2015
Risk Based Thinking

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INPUT PROCESS OUTPUT

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 Notable Changes

P-D-C-A
ISO9001:2015
Risk Based Thinking

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INPUT PROCESS OUTPUT

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 Notable Changes

- New additions:

- Documented Information = Documented Procedure

(appears 17 times)

- Documented Evidence = Quality Records

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 Notable Changes

- New additions:

- The explicit need to have the QMS use the Process

Approach (implement, maintain and audit the value-
added activities as a process)

- Managing the processes using the Plan-Do-Check-

Act cycle Using Risk-based thinking for

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establishment, implementation, maintenance and
continual improvement of the quality management
system,

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 Notable Changes

- New additions:

- Understanding the needs of the organization and

expectations of their interested parties and
stakeholders.

- Actions to address Risks and Opportunities. A formal

Risk Based program, such as the one defined in

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ISO31000 may be suitable for some organizations,
but not mandated.

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 Notable Changes

- New additions:

The overall emphasis on the stakeholders is

to ensure long term business success.
Internally, organizations can benefit from
these requirements as well by considering

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the guidance set forth in ISO 9004.

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 Upcoming Webinars

1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership March 25, 2015
6. Planning
7. Support April 29, 2015
8. Operation
9. Performance evaluation May 26, 2015

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10. Improvement
ISO 9001: Annex A-C Clarifications, Quality Management Principles, QMS family of standards.

And, one more after FDIS is issued to discuss the changes. .

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 Introduction Forward Section

- 0.1 General
-
- 0.2 The ISO Standards for Quality Management

- 0.3 Process Approach

- 0.4 Plan-Do-Check-Act Cycle (PDCA)

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- 0.5 Risk-Based Thinking

- 0.6 Compatibility with other management system

standards.
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 Introduction

0.1 General

The adoption of a quality

management system ought to be a

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strategic decision for an
organization.
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 0.1 General

Design & Implementation of QMS is influenced by the

context of the organization
a) its specific objectives
b) the risks associated with its context and
objectives
c) the needs and expectations of its customers and
other relevant interested parties
d) the products and services it provides
e) the complexity of processes it employs and
their interactions

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f) the competence of persons within or working on
behalf of the organization
g) its size and organizational structure
Determine the issues and requirements that can impact on the planning of
the Quality Management System. 27
 0.2 - Additional Sections

0.2 The ISO standards for quality management

ISO9001:2015 Standard (one of the 3 core standards)

ISO9000 Fundamentals and vocabulary

ISO9004 Managing for the sustained success of an

organization (lead to continual

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improvement of the organization)

- ISO10000 numbered standards

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 0.2 - ISO 10000 numbered standards

0.2 GUIDELINES
ISO10001 Customer Satisfaction ISO10012 Management of
Guidelines measurement processes
ISO10002 Customer Satisfaction ISO10013 QMS Documentation
handling complaints
ISO10003 Customer Satisfaction ISO10014 Realizing financial and
External Dispute economic benefits
ISO10004 Monitoring and Measuring
Customer Satisfaction
. ISO10015 Guidelines for Training

ISO10005 Guidelines for Quality Plans ISO10017 Guidance on Statistical

Techniques
ISO10006 Guidelines for Quality ISO10018 Guidance on People

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Management in Projects Involvement & Competence
ISO10007 Guidelines for Configuration ISO10019 Guidelines for the selection
Management of QMS consultants
ISO10008 Guidelines Electronic ISO19011 Guidelines for auditing
Commerce management systems
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 0.3 Process Approach

set of interrelated or interacting

activities which transforms inputs
into outputs

Document: ISO/TC 176/SC 2/N544R3

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Guidance on the Concept and Use of the Process Approach

(http://www.iso.org/iso/04_concept_and_use_of_the_pr
ocess_approach_for_management_systems.pdf )
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 0.3 - Benefits of Process Approach

Benefits of the process approach are:

Integration and alignment of processes to enable achievement of

desired outcomes
Ability to focus effort on process effectiveness and efficiency.
Provision of confidence to customers, and other interested
parties, about the consistent performance of the organization.
Transparency of operations within the organization.
Lower costs and creation of shorter cycle times, through the
effective use of resources.
Improved, consistent and predictable results.

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Provision of opportunities for focused and prioritized
improvement initiatives.
Encouragement of the involvement of people and the clarification
of their responsibilities.
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 0.3 - Definition of Process

INPUT PROCESS OUTPUT

set of interrelated or interacting

activities which transforms inputs into
outputs
Production Processes (stamping, welding, painting)
Management Processes (administration, audits, CAR, HR)

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Support Processes (maintenance, warehouse, purchasing)
Customer Processes (sales, customer satisfaction)

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0.3 - Identification/Interaction of Processes

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 DQS-UL Management Systems Solutions
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0.3 - Process Map - Example
 DQS-UL Management Systems Solutions
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0.3 - Process Map - Example
 DQS-UL Management Systems Solutions
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0.3 - Process Map - Example
 DQS-UL Management Systems Solutions
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0.3 - Process Map - Example
 DQS-UL Management Systems Solutions
0.3 - NOT A PROCESS MAP

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 DQS-UL Management Systems Solutions
0.3 - NOT A PROCESS MAP

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 DQS-UL Management Systems Solutions
0.3 - NOT A PROCESS MAP

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 DQS-UL Management Systems Solutions
0.3 - NOT A PROCESS MAP

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 0.3 - Definition of Process

INPUT PROCESS OUTPUT

set of interrelated or interacting

activities which transforms inputs into
outputs
Production Processes (stamping, welding, painting)
Management Processes (administration, audits, CAR, HR)

DQS-UL Management Systems Solutions

Support Processes (maintenance, warehouse, purchasing)
Customer Processes (sales, customer satisfaction)

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 0.3 - Process Approach

From Section 0.3:

This International Standard promotes

the adoption of a process approach
when developing, implementing and
improving the effectiveness of a quality
management system, to enhance

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customer satisfaction by meeting
customer requirements.

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 0.4 Plan-Do-Check-Act Cycle

P-D-C-A
INPUT PROCESS OUTPUT

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 0.4 Plan-Do-Check-Act Cycle

STAMPING

Plan

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 0.4 Plan-Do-Check-Act Cycle

STAMPING

Plan

INPUT
PROCESS OUTPUT
(DO)

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 0.4 Plan-Do-Check-Act Cycle
Internal Process
STAMPING Efficiency

Plan
Internal Process Process
Efficiency Effectiveness

INPUT
PROCESS OUTPUT
(DO)

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Parts Per Million
Machine Up Time
Check Parts Per Hour
Cost of Quality -
Internal Process rework
Efficiency 47
 0.4 Plan-Do-Check-Act Cycle

Act Plan

INPUT
PROCESS OUTPUT
(DO)

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Parts Per Million
Machine Up Time
Check Parts Per Hour
Cost of Quality -
rework
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 0.4 Plan-Do-Check-Act Cycle

Act Plan

INPUT
PROCESS OUTPUT
(DO)

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Check
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 0.5 Risk Based Thinking

0.5 Risk-based thinking

- concept has always been implicit

in ISO9001:2008

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- ISO9001:2015 makes it more
explicit

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 Notable Changes

P-D-C-A

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INPUT PROCESS OUTPUT

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 0.5 Risk Based Thinking

Risk is the effect of uncertainty on

an expected result.

a) Incorporated in requirements for the

establishment, implementation, maintenance and
continual improvement of the QMS.
b) May Use ISO31000 - but not required.
c) Not all processes represent the same level of risk.

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d) Considering Risk qualitatively to define the
QMS, processes and activities.

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 0.5 Risk Based Thinking

Document N1222 published by ISO/TC 176/SC2.

Document:ISO/TC176/SC2/N1222
Guidance on the Concept and Use of the Process
Approach

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http://isotc.iso.org/livelink/livelink/open/tc176SC2public

Look for presentation on ISO9001 and Risk at the end of

section 7. Also, article N1221 in section 1.
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 0.6 Compatibility

- ISO/IEC Directives, Part 1, Consolidated ISO

supplement, 2013, Annex SL,

High level structure and common text is public information and can be
found in Annex SL of the www.iso.org/directives

Organizations implementing multiple management

systems (e.g. quality, environmental, information
security) can achieve better integration and easier

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implementation

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 High Level Structure

1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation

DQS-UL Management Systems Solutions

10. Improvement
ISO 9001: Annex A-C Clarifications, Quality Management Principles, QMS family of standards; some
subclauses mandated as well.
Based on 7 Quality Management Principles

55
 Transition Plan

UL DQS
TRANSITION
PLAN

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ISO9001:2008 TO ISO9001:2015
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 Transition Plan

2015 2016 2017 2018

September 2015:
Published
International Standard

September 2015:

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Start of 3 years transition period to September 2018
 Transition Plan

An organization may be upgraded to

ISO9001:2015
- as part of its scheduled Recertification
Audit;
- in a planned manner through the
Continuous Assessment process with

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additional audit time, or
- through a Special Transition Audit.

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 2008 to 2015 Transition

The most cost-effective way is to

upgrade during the normally
scheduled Recertification Audit.

Upgrade audits done as part of the

Continuous Assessment and Special
audits will be carried out for the same

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number of days as a recertification
audit (including Stage 1 and Stage 2)
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 2008 to 2015 Transition

Topics to be verified during readiness review:

(in addition to verification of fulfillment of changed requirements)

Resonsibilities / actions

Knowledge about the changed requirements

Identification of gaps and action needs
Action plan / responsible persons
Awareness building in the organization

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Focus:
Context of the organization, leadership, and planning

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 2008 to 2015 Transition

Is a complete MR and internal audit expected

before certification against ISO 9001:2015?

Yes; Management review and internal audit on the

basis of ISO 9001:2015 have to be completed before
a certificate on ISO 9001:2015 can be issued. Stage
1 (readiness review) can be carried out before

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management review and a complete audit but the
need to complete it before stage 2 will be addressed
in the audit report.

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 2008 to 2015 Transition

Stage 1 Stage 2

Newly Implemented
< 3 years
On Site
On Site
Maintained / Monitored

On Site On Site

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Effective / Mature
(including Process Approach and
Risk-Based Thinking)
Off Site On Site

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 2008 to 2015 Transition

Please let your Customer Service

Representative know well in advance
of your audit when you are ready to
upgrade.

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Client Internal Auditor Training Plan

ISO9001:2008 to ISO 9001:2015

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 On Site Overview

Webinar

Client Internal Auditor Certification

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Program

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 On Site Overview

One Day on-site presentation

Provide Overview of the Standard

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No Certificate Issued

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 Webinars:

Done By Cindy Soltis - October 2014

February 18 2015 (provide update,

announce the transition plan, the

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Internal Auditor Certification program
and section 0 of the Standard)

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 Webinars: In-depth review of the
requirements

March 25, 2015 Sections 1-6

April 29, 2015 Sections 7-8

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May 26, 2015 Sections 9-10
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 Internal Auditor Certification Program

Internal Auditor Certification

Program

Partner up with the clients

Let you know what we know!

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Complete the UL DQS on line training
module and test.
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 Internal Auditor Certification Program

Client Certification

Attend a 2 day Training Session in

person (locations to be determined)
and participate in case studies.

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Get a Certificate of Training.

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 2008 to 2015 Transition

Please let your Customer Service

Representative know well in advance
if you are interested in receiving
Internal Auditor Training from

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UL DQS
http://ul-dqsusa.com/iso-90012015-training

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 Questions?

Please send your questions to:

DQS-UL Management Systems Solutions

[email protected]

Next Webinar: March 25, 2015

72
 Questions?

Contact me:

Joe Mansour
ISO9001:2015 Program Manager

Please send your questions to:

DQS-UL Management Systems Solutions

[email protected]

Next Webinar: March 25, 2015

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