Welcome

Sections 1-5
Revisions & Impact
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DQS-UL Management Systems Solutions

DIS ISO9001:2015 Overview

Joe Mansour
ISO9001:2015 Program Manager
Lead Auditor
BSEE, MSEE, MBA

Jawaid.Mansour@us.dqs-ul.com
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760-458-3879 (office/cell)

http://ul-dqsusa.com/iso-90012015/
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DQS-UL Management Systems Solutions

www.ul-dqsusa.com

Todays Presentation ISO9001:2015

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
May 26, 2015

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

Final Webinar on July 29, 2015 .

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9. Performance evaluation

Questions?

Next Webinar: April 29, 2015

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Please send your questions to:

ISO9001_2015_Questions@us.dqs-ul.com

Questions From The Last Webinar

Q1 What is the current difference between

element approach and process approach?

Element-based standards just outline the

requirements.
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Explanation of Process Approach was included in

slides 30-49. ISO9001:2015 requires all Processes
(value-added activities of the organization) be
identified and managed as a process.

Questions From The Last Webinar

Q2 What do you mean by the standard now

requires min 17 "documented information"
Retain Documented Information appears 17
times in the Standard. Namely, in sections 4.4,
6.2.1, 7.1.5, 7.2, 8.1.e), 8.2.3, 8.3.5, 8.3.6, 8.4.1,
8.5.2, 8.5.6, 8.6, 8.7, 9.1.1, 9.2.2, 9.3.2 and
10.2.2.

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This is equivalent to the current Quality Records requirement,

where the information can be in any media or format. For
clarification, please note that Maintain documented information
is equivalent to the current Documented Procedure requirement.

Questions From The Last Webinar

Q3 What does PDCA stand for?
Slides 15-19.

Act

INPUT

Plan
PROCESS
(DO)

OUTPUT

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Check

Questions From The Last Webinar

Q4 How do I obtain training in Risk

Management? Will numbering align with
ISO14k and the OHSAS18k?
We will be covering Risk Management as part of
our April 20 Webinar.

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TS16949, AS9100, TL9000 have already

indicated that they will update .

Questions From The Last Webinar

Q6 What will be the deadline to update

documentation to the 2015 standard after release?
If we just got re-certified, will we have to do it
again, or can we do it at the next 3 year cycle?

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Please refer to slides 56-63 and FAQ question A5.

Questions From The Last Webinar

Q7

The ISO 176 link is no longer valid. Can

you supply the new link?

As of March 25, 2015, the link is still active.

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

Questions From The Last Webinar

Q8

Can you provide the FAQ

location again?

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http://ul-dqsusa.com/iso-90012015

Questions From The Last Webinar

Q12 You showed several examples of "not a

process map" and one bad process map. Could
you explain what a good process map looks
like, requires, etc.?

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ISO9001:2015 requires all processes to be

identified. Furthermore, clause 4.4b requires the
sequence and interaction of the process be
defined.

Questions From The Last Webinar

Q16 So we will
have to re-do our
internal auditor
certifications that
we currently have?

Not necessarily.
Please see FAQ
questions B1, B2 and
B3.
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Questions From The Last Webinar

Q17

Why change to ISO 9001:2015, just stay at ISO

9001:2008.

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ISO committee is made up of 163 member countries,

each with a single vote. All ISO standards are normally
reviewed every five years to assure that they are still
relevant and adequate in an ever changing world.

Questions From The Last Webinar

Q26 For family owned companies, involvement
of management is very rare and the real actions
are really limited to the doers in the company. I
am afraid that we will not be able to implement
the new requirements

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On the contrary, the new requirements have been

defined so as to make them easier to implement in
smaller organizations. With reduced need for
documentation, the ISO9001:2015 is less
prescriptive.

Sections 1-5

Scope

Normative References

Terms and Definitions

Context of the Organization

Leadership

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Sections 1-5

Scope
Normative References

Terms and Definitions

Context of the Organization

Leadership

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Section 1- Scope

This Standard
specified
requirements
for a quality
management
system where
an organization

Needs to demonstrate its ability to

meet customer/statutory/regulatory
requirements
Aims to enhance customer
satisfaction

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All requirements are generic and intended to be

applicable to all types of organizations, regardless
of type, size and product (or service) provided.

Sections 1-5

Scope

Normative References
Terms and Definitions

Context of the Organization

Leadership

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Section 2

Normative References.

There are no normative references for DIS

ISO9001:2015.

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This section is included to maintain clause

numbering alignment with other ISO
management system standards.

Sections 1-5

Scope

Normative References

Terms and Definitions

Context of the Organization

Leadership

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Section 3 Terms & Definitions

3.02 INTERESTED PARTY

Person or organization (3.01) that can affect, be
affected by, or perceive themselves to be affected
by a decision or activity.

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3.01 person or group of people that has its own

functions (3.25) with responsibilities, authorities
and relationships to achieve its objectives (3.08)

Section 3 Terms & Definitions

3.06 - EFFECTIVENESS

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Extent to which planned activities are

realized and planned results achieved.

Section 3 Terms & Definitions

3.08
OBJECTIVE

Result to be
achieved.
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Section 3 Terms & Definitions

3.09 - RISK

Effect of
uncertainty on
an expected
result.

The effect can

be positive or
negative
consequence

- Risk is
characterized
by potential
events and
consequences.
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Section 3 Terms & Definitions

3.11 DOCUMENTED
INFORMATION

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Information (3.50) required to

be controlled and maintained
by an organization (3.01) and
the medium on which it is
contained.

Section 3 Terms & Definitions

3.12 PROCESS

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Set of interrelated or
interacting activities
which transforms
inputs into outputs
(3.46).

Section 3 Terms & Definitions

3.20 CORRECTIVE ACTION

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Action to eliminate the cause of a nonconformity

(3.19) and to prevent recurrence.

Section 3 Terms & Definitions

3.24 CONTEXT
OF THE
ORGANIZATION
(Business
Environment)

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- Business
Environment,
organizational
environment or
ecosystem of an
organization.

Combination of
internal and
external factors and
conditions that can
have an effect on
an organizations
approach to its
products, services
and investments,
and interested
parties.

Section 4 - Context Of The Organization

4.1 Understanding the Organization

and Its Context
4.2 Understanding The Needs And
Expectations Of Interested Parties

4.4 Quality Management System

And Its Processes
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4.3 Determining The Scope of The

Quality Management System

Section 4 - Context Of The Organization

4.1
Understanding the Organization and
Its Context
4.2 Understanding The Needs And
Expectations Of Interested Parties

4.4 Quality Management System

And Its Processes
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4.3 Determining The Scope of The

Quality Management System

4.1 Understanding-Organization-Context

UL DQS : Mission and values

We want to be the preferred partner for certification,
auditing, and assessments of management systems.
Values Our corporate values drive common attitudes:
Success -

Respect
We treat people with respect, always.

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We like to be successful, just like our customers.

4.1 Understanding-Organization-Context
Customer orientation
Customer needs come first generate value for customers.
Employee orientation
Our employees, auditors, are our greatest success factor.
Mutual trust
Mutual trust enables cooperation in achieving goals.
Responsibility
Take responsibility for results and behavior
Independence, competence and attitude to ensure integrity.
Reliability
Keep our promises. Trust us!

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Integrity / credibility

4.1 Understanding-Organization-Context

The vision drives the development of UL DQS. It

reflects the expectations of the essential stakeholders:
Preferred partner for certification, auditing, and
assessments;
Recognized for our competence in

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Supporting business success and organizational

health of our customers.

4.1 Understanding-Organization-Context
Other Internal Factors May Include
Management
Strategy

Employee
Satisfaction

Business
Continuity
Work
Environment
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Overall
Compensation

4.1 Understanding-Organization-Context

4.1 The organization shall determine external and

internal issues that are relevant to its purpose and
its strategic decision and that affect its ability to
achieve the intended results.

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The organization shall monitor and review the

information about these external and internal
issues.

4.1 Understanding-Organization-Context

Society

External
Environment

Suppliers

Internal
Environment
Customers

Government

Owners
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Financial

4.1 Understanding-Organization-Context

Politic
al
Cultur
al

Internal
Environment
Customers

Government

Owners
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Financial

Growth
Factors

Social

External
Environment

Suppliers

Demographic

Society

Section 4 - Context Of The Organization

4.1 Understanding the Organization

and Its Context
4.2 Understanding The Needs And Expectations
Of Interested Parties

4.4 Quality Management System

And Its Processes
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4.3 Determining The Scope of The

Quality Management System

4.2 Understanding Needs and Expectations

Due to impact on
organizations ability to meet
customer, statutory and
regulatory requirements, the
organization shall

Identify the requirements of

these interested parties

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Organization to monitor and

review the information about
these interested parties and
their relevant requirements.

Identify the interested parties

that are relevant to the quality
management system.

4.2 Understanding Needs and Expectations

Corporate
Policies of UL
DQS governed by

Customers
Employees and
Auditors
External Auditors,
Business Partners
Shareholders
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4.2 Understanding Needs and Expectations

Employee expectations

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UL DQS employees expect above-average working conditions and

jobs that provide learning opportunities in the long term. They also
expect an income commensurate with their performance, recognition
for their achievements, and support for attractive professional
development.

4.2 Understanding Needs and Expectations

Employee Policy - Example

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Employee commitment and competence is an essential principle of

success for business activities. With attractive working conditions,
performance-oriented culture, and respectful interaction with each
other, the goal is to be an organization preferred by employees..

Section 4 - Context Of The Organization

4.1 Understanding the Organization

and Its Context
4.2 Understanding The Needs And
Expectations Of Interested Parties

4.4 Quality Management System

And Its Processes
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4.3 Determining The Scope of The Quality

Management System

4.3 - Determining Scope of QMS

Products and
services covered by
the quality
management
system
Justification for any
instance where a
requirement of this
international
standard cannot be
applied. .

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The scope
shall be
available and
be maintained
as a
documented
information
stating the:

Section 4 - Context Of The Organization

4.1 Understanding the Organization

and Its Context
4.2 Understanding The Needs And
Expectations Of Interested Parties

4.4 Quality Management System And Its

Processes
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4.3 Determining The Scope of The

Quality Management System

4.4 - QMS and its Processes

The organization shall identify the processes

and shall determine:
The risks and
opportunities

The resources
needed

The sequence
and interaction of
these processes

The criteria,
methods, including
performance
indicators
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The assign of the

responsibilities
and authorities

The inputs
required and the
outputs expected

4.4 - QMS and its Processes

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)
Customer Processes (sales, customer satisfaction)
Service Processes (Bank- deposit, withdrawal, loan
processing, mortgage application, monthly statements)
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Support Processes (maintenance, warehouse, purchasing)

4.4 - QMS and its Processes

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4.4 QMS - and its Processes - Service

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4.4 - QMS and its Processes

STAMPING

Act

INPUT

Plan
PROCESS
(DO)

OUTPUT

Machine Up Time

Check

Parts Per Hour

Cost of Quality rework
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Parts Per Million

4.4 STAMPING Process Map

Inputs/Needs

Work Order
Material
identified with
tag

Process
Operations

Outputs/Results

Responsibility

Verify Schedule

Supervisor

Set up for
Production

Set Up Lead

Run First off

Inspect

Set Up Lead

Update NCMR
database

Q.C. Inspector

Y
Resume Full
Production

Operator

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Adjust setup

4.4 STAMPING Process Map

Quality Objectives For The Stamping Process
ACTUAL

GOAL

ACTION

PPM

25

50

Continue to
Monitor

Machine Up Time

82 %

95%

Increase PM, have

spare parts
available, staffing

Parts Per Hour

235

215

Continue to
Monitor

Cost of Rework

$496

<$500 per month

Continue to
Monitor/consider
risk

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OBJECTIVE

4.4 - QMS and its Processes

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4.4 - QMS and its Processes

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Sections 1-5

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5 - Leadership

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5 - Leadership

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Leadership

Leadership and Commitment

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Leadership

Leadership and Commitment

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Leadership

Leadership and Commitment

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5 - Leadership

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5 - Leadership

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5 - Leadership

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5 - Leadership

Quality Policy

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5 - Leadership

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5 - Leadership
Organizational Roles and
Responsibilities

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Maintain
Integrity

Questions?

Next Webinar: April 29, 2015

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Please send your questions to:

ISO9001_2015_Questions@us.dqs-ul.com

Questions?
Contact me:
Joe Mansour
ISO9001:2015 Program Manager

Next Webinar: April 29, 2015

70

DQS-UL Management Systems Solutions

Please send your questions to:

ISO9001_2015_Questions@us.dqs-ul.com