Changes to ISO9001/ISO14001

1
ISO9001:2015 /ISO14001:2015
Welcome
© DQS 2017 – All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any
means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission.

Presenters
Joe Mansour
ISO9001:2015 Program Manager
760--458-3879
Jawaid.Mansour@dqsus.com
Candace Orbaugh
856-728-5557
Candace.Orbaugh@dqsus.com
© DQS Inc.

© DQS Inc.
ISO9001:2015
ISO14001:2015
ANAB Accredited
Issued 9/15/2015

Previous 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
10. Improvement
4
… IS Webinar on July 29, 2015 .

ISO9001:2015/ISO14001:2015
© DQS Inc.
www.dqsus.com
ISO 9001:2015
ISO14001:2015

6
ISO
9001:2008
ISO 9001:2015
ISO
9001:2008
ISO 9001:2015
ISO
9001:2008
ISO 9001:2015
ISO
9001:2008
ISO 9001:2015
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
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
ISO9001:2008 vs. IS09001:2015

Notable Changes
Quality Manual
Management
Representative
Preventive
Action
© DQS Inc.

Notable Changes
PROCESSINPUT OUTPUT
P-D-C-A
ISO9001:2008 Preventive Action
© DQS Inc.

Notable Changes
PROCESSINPUT OUTPUT
P-D-C-A
ISO9001:2015
Risk Based Thinking
© DQS Inc.

ISO 9000:2015 – Terms & Definitions
3.4.1 – PROCESS
Set of interrelated or
interacting activities
which transforms inputs
into outputs.
11

Section 4 - Context Of The Organization
12
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

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.
© DQS Inc.

14
4.4 - QMS and its Processes

15
4.4 – QMS - and its Processes - Service

4.4 - QMS and its Processes
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The organization shall identify the processes and
shall determine:
The inputs
required and the
outputs expected
The sequence and
interaction of
these processes
The criteria,
methods, including
performance
indicators
The resources
needed
The assign of the
responsibilities
and authorities
The risks and
opportunities

4.4 – 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
Quality Objectives For The Stamping Process

4.4 – STAMPING Process Map
Quality Objectives For Support Process
Sales
• Revenue/Employee
• % Won
HR
• # of hires
• # of training hours
Cal
• # overdue
• # out of tolerance
Maint
• % On Time, MTTF
• Repair Time, Uptime

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PROCESS (DO)INPUT OUTPUT
Plan
Check
Act
PDCA Cycle

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 6 – Planning for QMS
21
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.
d) Considering Risk “qualitatively” to define the QMS,
processes and activities.
Risk is the effect of uncertainty on an
expected result.

6.1 – Actions – Risks & Opportunities
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Addressing Risks/Opportunities
Determine Risks
and Opportunities
per sections 4.1
and 4.2
Actions to Address
Risks
Establish Quality
Objectives
Manage QMS
Change

Section 6 – 7 R’s of Risk Management
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Recognition of Risks
Ranking or Evaluation of Risks
Responding to Significant Risks
Resourcing Controls
Reaction Planning
Reporting and Monitoring
Reviewing Framework

Section 6 – 4 T’s of Risk Management
25
Tolerate
Treat
Transfer
Terminate
RespondingTo
SignificantRisks

Section 6 – Planning for QMS
Identify The
Risks
Analyze &
Prioritize
Plan Actions
to address
Take Action
Check
Effectiveness
Learn &
Improve
26

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SEVERITY
1 No relevant effect
2 Very Minor, no damage
3 Minor, low damage
4 Moderate
5 Critical (loss of primary
function)
6 Catastrophic
OCCURANCE
1 Extremely Unlikely
2 Remote
3 Occasionally
4 Reasonably Possible
5 Frequent
DETECTION
1 Certain
2 Almost Certain
3 High
4 Moderate
5 Low
6 Undetectable
Risk Priority Number (RPN)
=
Severity * Occurance *
Detection
FMEA - RPN

Section 6 – Failure-Mode-And-Effect (FMEA)
28
RPN= Severity * Occurrence * Detection
RPN= Risk Priority Number

Candace Orbaugh
856-728-5557
Candace.Orbaugh@dqsus.com
 ISO14001:2015
© DQS Inc.

ISO-14001:2015 Key Changes
ISO-14001:2015 ISO-14001:2004 Key changes
Introduction Introduction Background, Aim of Environmental system,
Success Factors, PDCA
1 Scope 1 Scope No significant change
2 Normative
References
2 Normative
Reference
No significant change
3 Terms and
Definitions
3 Terms and
Definitions
Definitions of a few new terms including
‘documented information, life cycle
perspective’
May 16, 2017© DQS Group 31

Life cycle
3.3.3
life cycle
consecutive and interlinked stages of a product (or service) system, from raw
material acquisition or generation from natural resources to final disposal.
Note 1 to entry: The life cycle stages include acquisition of raw materials,
design, production, transportation/ delivery, use, end-of-life treatment and final
disposal.
16.05.2017 32

 ISO 14001:2015 requires taking a life cycle perspective.
In Annex A6.1.2, a life cycle perspective is explained as
follows: “This does not require a detailed life cycle
assessment; thinking carefully about the life cycle stages
that can be controlled or influenced by the organization
is sufficient”. The life cycle stages of a product (or
service) include acquisition of raw materials, design,
production, transportation/delivery, use, end-of life
treatment and final disposal (3.3.3). In Clause 6.1.2, ISO
14001:2015 requires the organization to consider these
life cycle stages when determining the environmental
aspects that it can control or can influence.

4 Context of the organization
4.1 Understanding the
organization and its
context
New requirement for the
organization to determine
external and internal issues
that are relevant to its
purpose and that affect its
ability to achieve the
intended outcomes of its
environmental
management system.
4.2 Understanding the
needs & expectations of
interested parties
Interested parties is now a
requirement of the new
standard
4.3 Determining the scope 4.1 General Requirements Similar, but with added
detail and includes
interested parties

Context of organisaton
Determining the scope of the environmental management system (4.3)
The organization shall determine the boundaries and applicability of the
environmental management system to establish its scope.
(functional unit, boundaries, remote locations, temp. Sites..)

 How will the organization demonstrate that they have
considered life cycle when determining aspects (6.1.2)
and when planning and controlling operations, including
design through end of life?

4.4 Environmental
Management System
4.1 General Requirements In addition to previous
requirements, new
requirement to consider
context and achieving
intended outcomes

5.1 Leadership and
Commitment
New clause with expanded
requirements for top
management.
5.1 Leadership and commitment
Top management shall demonstrate leadership and commitment with respect to
the environmental management system by:
• taking accountability for the effectiveness of the environmental management
system;
• ensuring that the resources needed for the environmental management
system are available;
• ensuring that the environmental management system achieves its intended
outcomes;
• supporting other relevant management roles to demonstrate their leadership
as it applies to their areas of responsibility;

5.1 Leadership and
Commitment
New clause with expanded
requirements for top
management.
3.1.5 top management
person or group of people who directs and controls an organization (3.1.4) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within
theorganization.
Note 2 to entry: If the scope of the management system (3.1.1) covers only part of an organization, then top
management refers to those who direct and control that part of the organization.
Section A51 in Annex A of guidance
To demonstrate leadership and commitment, there are specific responsibilities related to the
environmental management system in which top management should be personally involved
or which top management should direct. Top management may delegate responsibility for
these actions to others, but it retains accountability for ensuring the actions are performed.

5.2 Environmental Policy 5.2 Environmental Policy Same basic requirements
5.3 Organizational roles,
responsibilities, and
authorities
4.4.1 – Resources, Roles,
responsibility, and
authority
New clause to split out
resources.

risks and opportunities
6.1 Actions to address risks
and opportunities
6.1 General
6.1.2 Environmental
aspects
New requirement relating
to risk
Risks and opportunities are defined as potential adverse effects (threats) or
beneficial effects (opportunities), which may result from environmental
aspects, compliance obligations, or from other issues and requirements
identified as part of the context of the organization. The intent is for the
organization to determine which risks or opportunities it considers to be
important to address within its EMS, in order to achieve the intended
outcomes of its EMS and support continual improvement.

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Actions to address risks and opportunities
4.1 external
and internal
issues
4.2 interested
parties
6.1.3 Compliance
obligations
6.1.2
Environmental
aspects
4.3 scope of the
environmental
management
system
determine risks and
opportunities
Risks and Opportunities

6.1.3 Compliance obligations 4.3.2 Legal and Other
Requirements
Basically the same
requirement, new clause
number
6.1.4 Planning Action Specifically requires the
organization to take action
with regards to significant
environmental aspects and
compliance obligations.

6.2 Environmental
objectives and planning
4.3.3 Objectives, targets,
and programs
Requirements are the
same, but additional detail
added
7.1 Resources 4.4.1 – Resources, Roles,
responsibility, and
authority
Same requirements, but a
separate clause
7.2 Competence 4.4.2 Competence,
training, and awareness
Same requirement,
highlighted by separating
the clauses
7.3 Awareness 4.4.2 Competence,
training, and awareness
Same requirement,
highlighted by separating
the clauses

7.4 Communication
7.4.1 General
7.4.2 Internal communication
7.4.3 External Communication
4.4.3 Communication Same basic requirements.
Internal and external
communications separated
out to demonstrate equal
importance
7.5 Documented information 4.4.4 Documentation
4.4.5 Control of
documents
4.5.4 Control of
records
Documents and records
included in same clause.
Basic requirements of both
remain the same

8.1 Operational planning
and control
4.4.6 Operational
control
Includes a few additional items,
including control of outsourced
processes, change management,
lifecycle during purchasing and
design.

 ISO 14001:2015 defines “outsource” as “make an arrangement
where an external organization performs part of an organization’s
function or process”. A process or service obtained from an external
provider is not necessarily an outsourced process. Outsourced
processes can be viewed as a subset of these externally provided
processes or services.
 Criteria that an organization can use to distinguish outsourced
processes from other processes and services are described in
Annex A.8.1, which states that an outsourced process is one that
fulfils all of the following:
 it is within the scope of the environmental management system;
 it is integral to the organization’s functioning;
 it is needed for the environmental management system to achieve its
intended outcome;
 liability for conforming to requirements is retained by the organization;
 the organization and the external provider have a relationship where the
process is perceived by interested parties as being carried out by the
organization.

8.2 Emergency Preparedness &
response
4.4.7 Emergency
Preparedness &
response
Same basic requirements

9.1 Monitoring, measurement,
analysis & evaluation
9.1.1 General
4.5.1 Includes requirements for
monitoring and
measurement related to
aspects, compliance
obligations, operational
controls, etc
9.1.2 Evaluation of compliance 4.5.2 Evaluation of
compliance
Same requirements
9.2 Internal Audit 4.5.5 Internal Audits Same basic requirements

9.3 Management Review 4.6 Management
Review
Same input requirements.
Output must include
opportunities to improve
integration of the EMS with
other business processes
and any implications for
the strategic direction of
the organization.
10.1 Improvement Organization must
determine opportunities
for improvement
10.2 Nonconformity and
Corrective action
4.5.3 Nonconformity,
corrective action and
preventive action
Basically equivalent, the
specific term preventive
action was removed

10.3 Continual Improvement The organization shall
continually improve the
suitability, adequacy and
effectiveness of the
environmental
management system to
enhance environmental
performance.

© DQS Inc.
TOP 10
Context of the organization – requires an understanding of the
external and internal factors that could impact the
organization’s ability to meet its objectives.
Identification of Stakeholders and Interested Parties –
Although self-evident, the revised standards enlarge the
group of stakeholders and interested parties beyond
customers and owners / shareholders of the organization.
#1
#2

© DQS Inc.
TOP 10
Risk-based Thinking – An added dimension to decision making
at all levels within the organization and encourages the
consideration of risks and opportunities with achieving the
desired objectives.
Process Approach – A challenge even before the 2015 revisions.
Organizations continue to address their management systems
on the obsolete clause basis and are in the journey of thinking
along business processes.
#3
#4

© DQS Inc.
TOP 10
Out-sourced Processes – The applicability of these requirements
has not changed and yet the type of control to be exercised
over outsourced processes includes consideration of the
environmental aspects and impacts over the life cycle of the
product or service.
Leadership and Commitment – The requirement to
demonstrate commitment
#5
#6

© DQS Inc.
TOP 10
Multi-Site Coordination – Larger organizations have an
increased level of complexity with multiple locations and
assuring consistent roll-out of business processes across the
locations.
Timing – In many large organizations, the timing decision on
planning and implementing upgrades to the 2015 revision is
made at a corporate or divisional level. While global or
corporate processes are more conducive for changes with a
short lead-time,
#7
#8

© DQS Inc.
TOP 10
Terminology – The revised standards indeed include new
terminology for business concepts currently in place
Outcomes and Performance – One of the significant changes is
the focus on “output matters” and “performance”.
#9
#10

Upgrade Audits
Options
QM08
to
QM15
UM to
UM15

Transition Plan
September 2015:
Start of 3 years transition period to September 2018
September 2015:
Published International
Standard

Upgrade Audits
Available on www.dqsus.com, under
ISO9001:2015 Informational Sessions

During a scheduled Recertification Audit; with minimal
additional days, if needed
In a Planned Manner During A Surveillance Audit as
“Stage 2 Upgrade Assessment”/Days same as TRI
In a Planned Manner During A Surveillance Audit
with additional Days as “Surveillance Upgrade
Assessment”
Through a Special Transition Audit with performing a
“Stage 2 Upgrade Assessment”.
Transition Plan
An Organization may be upgraded to
ISO9001:2015 or ISO14001:2015
© DQS Inc.

During a scheduled Recertification Audit; with minimal
additional days, if needed – Stage 2 Upgrade Assessment
Stage 1
Stage 2 – number of days for a recertification audit, with
no reductions
New Certificate Issued. New Certification cycle. Good for
3 years.
Upgrade during a normal recert audit
© DQS Inc.

In a Planned Manner During A Surveillance Audit as
“Stage 2 Upgrade Assessment”/Days same as TRI
Stage 1
Stage 2 – number of days for a recertification audit,
with no reductions
New Certificate Issued. New Certification cycle.
Good for 3 years.
Stage 2 upgrade during a surveillance
© DQS Inc.

In a Planned Manner During A Surveillance Audit with additional
Days as “Surveillance Upgrade Assessment”.
Stage 1
Stage 2 – number of days for Surveillance audit, with additional
days (~35%) for a Surveillance Upgrade Assessment.
New Certificate Issued. Does not reset the certification cycle. No
change in certificate expiration date.
Surveillance Upgrade Assessment
© DQS Inc.

Through a Special Transition Audit with performing
a “Stage 2 Upgrade Assessment”.
Stage 1
Stage 2 – number of days for a recertification audit,
with no reductions
New Certificate Issued. New Certification cycle.
Good for 3 years.
Stage 2 upgrade audit at Special visit
© DQS Inc.

2008 to 2015 Transition
•Stage 1 upgrade
assessment
•Stage 2 upgrade
assessment
© DQS Inc.
ForUpgrades
All Upgrade Options Require Stage 1.

66
Identification of Interested Parties and their
requirements.
Identification of Gaps and actions needed
Identification of Risks and Opportunities
Identification of Processes
Context of the Organization and Leadership
Requirements

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Review of one round of process-based Internal
Audits to ISO9001:2015
At least one management review after the
completion of the audits.
Ensure Understanding of the Requirements
Deployment of Process-based Management
System
Stage 1 to be done about 2-3 months prior to
Stage 2.
Develop the Stage 2/Upgrade Assessment agenda
Review of QF-0900-9 / confirmation of Stage 2 Assessment days

69
ISO9001/ISO14001:2015 Transition
Process and Requirements
Availability of Gap
Assessments
ISO9001/14001:2015 Available Services

Please let your
Customer Service
Representative
know should be
interested in these
services and your
Upgrade Plans.
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Changes to ISO9001/ISO14001

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