Webinar March 2015 Final

Welcome
DQS-UL Management Systems Solutions

DIS ISO9001:2015 Overview
Sections 1-5
Revisions & Impact
1
Joe Mansour
ISO9001:2015 Program Manager
Lead Auditor
BSEE, MSEE, MBA

760-458-3879 (office/cell)
Jawaid.Mansour@us.dqs-ul.com
2
www.ul-dqsusa.com

http://ul-dqsusa.com/iso-90012015/
3
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
9. Performance evaluation May 26, 2015

10. Improvement
ISO 9001: Annex A-C Clarifications, Quality Management Principles, QMS family of standards.
Final Webinar on July 29, 2015 .

4
Questions?
Please send your questions to:

ISO9001_2015_Questions@us.dqs-ul.com
Next Webinar: April 29, 2015

5
Questions From The Last Webinar
Q1 What is the current

difference between element
approach and process approach?
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.

Element-based standards just outline
the requirements.
6
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.

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.
7
Q3 What does PDCA stand for?

Slides 15-19.
Act Plan
INPUT
PROCESS OUTPUT
(DO)

Check
8
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.

TS16949, AS9100, TL9000 have already
indicated that they will update .
9
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?

Please refer to slides 56-63 and FAQ question A5.
10
Q7 The ISO 176 link is no longer valid.

Can you supply the new link?

http://isotc.iso.org/livelink/livelink/open/tc176SC2public.
As of March 25, 2015, the link is still active.
11
Q8 Can you provide the FAQ

location again?
http://ul-dqsusa.com/iso-90012015/

12
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.?
ISO9001:2015 requires all processes to be

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

defined.
13
Q16 So we will
have to re-do our Not necessarily.
internal auditor Please see FAQ
certifications that questions B1, B2 and
we currently have? B3.

14
Q17 Why change to ISO 9001:2015, just stay at

ISO 9001:2008.

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.
15
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
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.
16
Sections 1-5
1 Scope
2 Normative References
3 Terms and Definitions
4 Context of the Organization

5 Leadership
17
Sections 1-5
1 Scope

5 Leadership
18
Section 1- Scope
This Standard
specified Needs to demonstrate its ability to
requirements meet customer/statutory/regulatory
for a quality requirements
management Aims to enhance customer
system where satisfaction
an organization

All requirements are generic and intended to be
applicable to all types of organizations, regardless
of type, size and product (or service) provided.
19
Sections 1-5
1 Scope

5 Leadership
20
Section 2
2 Normative References.
There are no normative references for DIS

ISO9001:2015.
This section is included to maintain clause
numbering alignment with other ISO
management system standards.

21
Sections 1-5
1 Scope


5 Leadership
22
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.
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)
23
3.06 - EFFECTIVENESS
Extent to which planned activities are

realized and planned results achieved.

24
3.08 Result to be
OBJECTIVE achieved.

25
- Risk is
Effect of The effect can
characterized
uncertainty on be positive or
3.09 - RISK by potential
an expected negative
events and
result. consequence
consequences.

26
3.11 DOCUMENTED
INFORMATION
Information (3.50) required to

be controlled and maintained
by an organization (3.01) and

the medium on which it is
contained.
27
3.12 PROCESS
Set of interrelated or

interacting activities
which transforms
inputs into outputs
(3.46).
28
3.20 CORRECTIVE ACTION
Action to eliminate the cause of a nonconformity

(3.19) and to prevent recurrence.

29
3.24 CONTEXT
OF THE
ORGANIZATION
(Business
Environment)
Combination of
internal and
external factors and
- Business
conditions that can

Environment,
have an effect on
organizational
an organizations
environment or
approach to its
ecosystem of an
products, services
organization.
and investments,
and interested
parties.
30
Section 4 - Context Of The Organization
4.1 Understanding the

Organization and Its Context
4.2 Understanding The Needs And

Expectations Of Interested Parties
4.3 Determining The Scope of The

Quality Management System

4.4 Quality Management System
And Its Processes
31
4.1 Understanding the Organization

and Its Context



And Its Processes
32
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 -
We like to be successful, just like our customers.

Respect
We treat people with respect, always.

33
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

Integrity / credibility
Independence, competence and attitude to ensure integrity.
Reliability
Keep our promises. Trust us! 34
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

Supporting business success and organizational
health of our customers.
35
Other Internal Factors May Include
Overall Management
Compensation Strategy
Employee Business

Satisfaction Continuity
Work
Environment
36
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.
The organization shall monitor and review the

information about these external and internal
issues.

37
Society
External
Suppliers
Environment
Internal
Environment
Customers Government

Financial Owners
38
Demographic
Society
Political
External
Suppliers
Environment
Cultural
Internal
Environment
Growth Factors
Customers Government

Social
Financial Owners
39

4.2 Understanding The Needs And Expectations

Of Interested Parties


And Its Processes
40
4.2 Understanding Needs and Expectations
Identify the interested parties

that are relevant to the quality
Due to impact on management system.
organizations ability to meet
customer, statutory and
regulatory requirements, the
organization shall Identify the requirements of
these interested parties
Organization to monitor and
review the information about
these interested parties and

their relevant requirements.
41
Corporate
Policies of UL
DQS governed by
Customers
Employees and
Auditors
External Auditors,
Business Partners
Shareholders

42
Employee expectations
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.

43
Employee Policy - Example
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..

44


4.3 Determining The Scope of The Quality

Management System

And Its Processes
45
4.3 - Determining Scope of QMS
The scope Products and

services covered by
shall be the quality
available and management
system
be maintained Justification for any
as a instance where a
documented requirement of this
international
information

standard cannot be
stating the: applied. .
46




4.4 Quality Management System And Its
Processes
47
4.4 - QMS and its Processes
The organization shall identify the processes

and shall determine:
The inputs
The risks and
required and the
opportunities
outputs expected
The assign of the The sequence

responsibilities and interaction of
and authorities these processes

The criteria,
The resources methods, including
needed performance
indicators
48
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)

Support Processes (maintenance, warehouse, purchasing)
Customer Processes (sales, customer satisfaction)
Service Processes (Bank- deposit, withdrawal, loan
processing, mortgage application, monthly statements)
49
50
4.4 QMS - and its Processes - Service

51
STAMPING
Act Plan
INPUT
PROCESS OUTPUT
(DO)

Parts Per Million
Machine Up Time
Check Parts Per Hour
Cost of Quality -
rework
52
4.4 STAMPING Process Map
Inputs/Needs Process Outputs/Results Responsibility

Operations
Work Order
Verify Schedule Supervisor
Material
identified with Set up for
Set Up Lead
tag Production
Run First off Adjust setup Set Up Lead

N
Update NCMR
Inspect Q.C. Inspector
database
Y
Resume Full
Operator 53
Production
4.4 STAMPING Process Map
Quality Objectives For The Stamping Process
OBJECTIVE 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
55
The organization shall maintain

documented information to the
extent necessary to support the
operation of processes and
retain documented information to
the extent necessary to have
confidence that the processes

are being carried out as planned.
56
Sections 1-5
1 Scope

5 Leadership
57
5 - Leadership
5.1 Leadership and Commitment
5.1.1 Leadership and commitment for the QMS

5.1.2 Customer Focus
5.2 Quality Policy

5.3 Organizational roles, responsibilities
and authorities
58
5 - Leadership

5.2 Quality Policy

and authorities
59
Leadership
Leadership and Commitment
Taking Ensure Quality

accountability Policy &
of Objectives in
Effectiveness place

Ensure QP is Integration of
communicated QMS with
and business
understood processes
60
Leadership
Promoting
awareness Availability of
/Process Resources
Approach

Communicate Ensure QMS
the achieves
importance of intended
effective QMS results
61
Leadership
Engaging, Promoting
directing and Continual
supporting Improvement

Support
other
management
roles
62
5 - Leadership

5.2 Quality Policy

and authorities
63
5 - Leadership

5.2 Quality Policy

and authorities
64
5 - Leadership

5.2 Quality Policy

and authorities
65
5 - Leadership
Quality Policy is appropriate to the

purpose and context of
the organization
Provides a framework for
setting and reviewing
quality objectives
Includes a commitment
to continual improvement
of the quality
management

Includes a commitment
to satisfy applicable
requirements
66
5 - Leadership
5.1 Leadership and

Commitment
5.1.1 Leadership and commitment for
the QMS
5.2 Quality Policy

5.3 Organizational roles,
responsibilities / authorities
67
5 - Leadership
Organizational Roles and

Responsibilities
system
all processes
conforms to
are delivering
the
their intended
requirements
results
of ISO
reporting on promotion of

the customer
performance focus
Maintain
Integrity
68
Questions?


69
Questions?
Contact me:
Joe Mansour
ISO9001:2015 Program Manager


70

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Welcome

DQS-UL Management Systems Solutions

DQS-UL Management Systems Solutions

DQS-UL Management Systems Solutions

DQS-UL Management Systems Solutions

Final Webinar on July 29, 2015 .

Please send your questions to:

DQS-UL Management Systems Solutions

Next Webinar: April 29, 2015

Q1 What is the current

DQS-UL Management Systems Solutions

Q2 What do you mean by the standard

Retain Documented Information appears 17

DQS-UL Management Systems Solutions

Q3 What does PDCA stand for?

DQS-UL Management Systems Solutions

Q4 How do I obtain training in Risk

We will be covering Risk Management as part of

DQS-UL Management Systems Solutions

Q6 What will be the deadline to update

DQS-UL Management Systems Solutions

Q7 The ISO 176 link is no longer valid.

DQS-UL Management Systems Solutions

Q8 Can you provide the FAQ

DQS-UL Management Systems Solutions

Q12 You showed several examples of "not a

ISO9001:2015 requires all processes to be

DQS-UL Management Systems Solutions

DQS-UL Management Systems Solutions

Q17 Why change to ISO 9001:2015, just stay at

DQS-UL Management Systems Solutions

Q26 For family owned companies, involvement

On the contrary, the new requirements have been

DQS-UL Management Systems Solutions

3 Terms and Definitions

4 Context of the Organization

DQS-UL Management Systems Solutions

3 Terms and Definitions

4 Context of the Organization

DQS-UL Management Systems Solutions

DQS-UL Management Systems Solutions

4 Context of the Organization

DQS-UL Management Systems Solutions

There are no normative references for DIS

DQS-UL Management Systems Solutions

3 Terms and Definitions

DQS-UL Management Systems Solutions

3.02 INTERESTED PARTY

Person or organization (3.01) that can affect, be

3.01 person or group of people that has its own

DQS-UL Management Systems Solutions

Extent to which planned activities are

DQS-UL Management Systems Solutions

DQS-UL Management Systems Solutions

DQS-UL Management Systems Solutions

Information (3.50) required to

DQS-UL Management Systems Solutions

DQS-UL Management Systems Solutions

3.20 CORRECTIVE ACTION

Action to eliminate the cause of a nonconformity

DQS-UL Management Systems Solutions

DQS-UL Management Systems Solutions

4.1 Understanding the

4.2 Understanding The Needs And