ISO-DIS 9001 Seminar Handout Final PDF

ISO/DIS 9001:2014 and the shape of things to come
Presented by
Lloyds Register Quality Assurance (Singapore)

Improving performance,
reducing risk
Introduction
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What we do
Established in 1985 by Lloyds Register (LR).

1st Certification Body to gain UKAS
accreditation in 1986.
1986
LRQA held more than 50 Accreditations
globally.
Provides Certification,
Certification 2nd Party Audit and
Training to internationally recognised
management system standards.
1,100 assessors worldwide in 47 countries.
countries
LRQA offers CERTIFICATION & TRAINING services in the following management system standards:
ISO 9001, ISO 14001, OHSAS 18001, ISO 22000, FSSC 22000, HACCP, ISO/PAS 28007,
28007 ISO 28000,
28000 ISO 22301,
ISO 50001,
50001 ISO/TS 29001, ISO/TS 16949, ISO 13485, GDPMDS, BRC, ISO 14064,, ISO 29990,
29990 AS 91XX, TAPA,
etc.
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Objectives of the seminar

This seminar will:
1.
Introduce you to Annex SL, the new high level structure (HLS) of all
ISO Standards.
2.
Provide an overview of what is new to the standard and what has

changed from ISO 9001:2008.
3.
Help you identify the potential implications for your organisation

of the changes to ISO 9001.
4.
Help you identify what you need to do to plan for your

organisations transition to ISO 9001:2015.
5.
Provide you with a useful reference guide.

guide
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Disclaimer
Whilst every care has been taken to ensure that the
dates indicated in this presentation are correct,
timescales - that are out of our control - can change.
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The current timescale to publication
June
2012
December
2012
April
2013
May
2014
March
2015
September
2015
Draft design
spec. and
WDO
Approved
design spec
and WD1
CD for
comment
and ballot
ISO/DIS
9001:2014
published
for
comment
(3 months)
Proposed
FDIS
publication
Proposed
ISO
9001:2015
publication
Please note that these timescales are subject to change.
Proposed
Transition
Period
3 years from
standard
publication
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What does ISO/DIS 9001:2014

mean for me and my
organisation?
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How significant are the changes to my organisation?
Implications for
your
organisation
Dependent on
your
organisations
circumstances
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ISO/DIS 9001:2014
Key areas of change to documented requirements
Clause No: Title
Item
Change
1: Scope
Scope
Now states intended result(s)
2: Normative References
Normative References
Essentially these are requirements
3: Terms and Definitions
Terms and Definitions
Some amendments and clarifications
4: Context of the
organization
Context of the
organization
New requirements
5: Leadership
Leadership
Greater area of focus, integral to business processes and

accountability
6: Planning
Risks/Opportunities
Planning of changes
New requirement
Greater area of focus
7: Support
Knowledge
Documented
Information
New requirement
New requirement
8: Operation
Outsourcing
Design & Development
Post Delivery Activities
New requirement
Requirements made clearer
9: Performance Evaluation
Performance indicators
Management Review
Greater area of focus on risk(s) and performance

10: Improvement
Continual Improvement
Clarification on approach and structure, removal of

preventive action
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The role of Annex SL in the

ISO/DIS 9001:2014
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Annex SL - Implications
Annex SL is the structure for all new and revised ISO Standards.
Annex SL (previously ISO Guide 83) defines the framework for a generic
management system.
All new ISO management systems standards (MSS) will adhere to this
framework and all current MSS will migrate at their next revision.
Whilst the structure and terminology has changed, there is no

requirement to use these terms or to follow the numbering or structure
within your management system
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Annex SL - Every ISO standard now has to demonstrate
1. MARKET RELEVANCE
Have the needs of all users been considered?
2. COMPATIBILITY
Is it compatible with other standards and there is no overlap or conflict?
3. TOPIC COVERAGE
Is it sector specific, could a generic standard be used?
4. FLEXIBILITY
Will it allow an organisation to add to/ innovate for competitive advantage?
5. FREE TRADE
Could it form a technical barrier to global trade?
6. APPLICABILITY
How would an organisation prove conformity?
7. EXCLUSIONS
Is the purpose deliberately to exclude competitors?
8. EASE OF USE
Could the user of the standard easily implement the requirements?
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Annex SL - The standard clauses
ISO 9001:2008
ISO 9001: 2015
0. Introduction
0. Introduction
1. Scope
1. Scope
2. Normative Reference
2. Normative Reference
3. Terms and Definitions
3. Terms and Definitions
4. Quality Management Systems
4. Context of the organization

5. Leadership
5. Management Responsibility
6. Planning for the quality management system
6. Resource Management
7. Support
7. Product Realisation
8. Operation
8. Measurement, Analysis &

Improvement
9. Performance Evaluation
10.Improvement
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Management of Risk,
Opportunity and Change
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What is risk based thinking?
Risk-based thinking is something we all do automatically and often subconsciously.

The concept of risk has always been implicit in ISO 9001 this revision
makes it more explicit and builds it into the whole management system.
Risk-based thinking is already part of the process approach.
Risk-based thinking makes preventive action part of the routine.
Risk is often thought of only in the negative sense. However, risk-based
thinking can also help to identify opportunities. This can be considered to
be the positive side of risk.
Source - ISO/TC 176/SC 2/WG23 N065
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How does risk relate to ISO 9001 - the main objectives
To provide confidence in the organisations ability to consistently provide

customers with conforming goods and services.
To enhance customer satisfaction.
The concept of risk in the context of ISO 9001 relates to

the uncertainty in achieving these objectives
Source - ISO/TC 176/SC 2/WG23 N065
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Risks & Opportunities A simple example
Neighbour
Customer
Regulator
Town
Council
Government
Sustainable
Happiness
Employer
Supplier
Community at
large
Family
members
Sustainable
Business
Competitor
Interest Group
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Risks & Opportunities A simple example
Risk
Inconsiderate Neighbour
Town Council
Opportunities
Move house (rent out/
buy new)
Soft talk
Engage town council /
police
Sustainable
Happiness
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Risks & Opportunities a simple example
Risk
Increase in price
materials by supplier
of
raw
Customer
Opportunities
Use alternative materials
Obtain from alternative sources
Bulk purchase
Revise the design to eliminate
material needs
Terminate product
Sustainable
Business
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Whats new?
The requirements of each clause
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ISO/DIS 9001:2014
Key areas of change to documented requirements
Clause No: Title
Item
Change
1: Scope
Scope
2: Normative References
Normative References
Essentially these are requirements
3: Terms and Definitions
Terms and Definitions
Some amendments and clarifications
4: Context of the
organization
Context of the
organization
New requirements
5: Leadership
Leadership
Greater area of focus, integral to business processes and

accountability
6: Planning
Risks/Opportunities
Planning of changes
New requirement
7: Support
Knowledge
Documented
Information
New requirement
New requirement
8: Operation
Outsourcing
Design & Development
Post Delivery Activities
New requirement
Requirements made clearer
9: Performance Evaluation
Performance indicators
Management Review
Greater area of focus on risk(s) and performance

10: Improvement
Continual Improvement
Clarification on approach and structure, removal of

preventive action
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Whats new? Clauses 1, 2, 3
Clause 1: Scope
Clause 2: Normative references
No substantive change
Clause 3: Terms and definitions
Terms and definitions are still

under active discussion and are not
finalised
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Whats new? - Clause 4 onwards becomes the HLS
The High Level Structure (HLS) - Annex SL - provides a set

of core elements that will be in all ISO management
systems standards.
PLAN
DO
CHECK
ACT
9.
PERFORMANCE
EVALUATION
10.
IMPROVEMENT
4.
5.
6.
7.
8.
CONTEXT OF
THE
ORGANIZATION
LEADERSHIP
PLANNING
SUPPORT
OPERATION
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Whats new? - Clauses 4 onwards becomes the HLS

PLAN
4.
CONTEXT OF
THE
ORGANIZATION
5.
LEADERSHIP
6.
PLANNING
7.
SUPPORT
DO
CHECK
ACT
8.
OPERATION
9.
PERFORMANCE
EVALUATION
10.
IMPROVEMENT
Operational planning and

control
Understanding
of the
organization
and its context
Leadership and
commitment
Actions to
address risk
and
opportunities
Needs and
expectations of
interested
parties
Quality policy
Quality
objectives &
planning to
achieve them
Competence
Scope of
management
system
Roles,
responsibilities
and authorities
Planning of
changes
Awareness
Resources
Determination of
requirements for products
and services
Design and development of
products and services
Monitoring,
measurement,
analysis and
evaluation
Nonconformity
and corrective
action
Control of externally
provided products and
services
Internal audit
Production and service
provision
Continual
improvement
Release of products and

services
QMS and its
processes
General
Communication
Control of nonconforming
process outputs, products and
services
Management
review
Documented
information
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Model of a process-based quality management system (Ref: ISO/DIS9001:2014)
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Schematic Presentation of a Single Process (Ref: ISO/DIS 9001:2014)
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Implications
How will these changes affect my
organisation?
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Annex SL - Implications
Annex SL will drive management systems standards
(MSS) integration, thereby delivering increased benefits
and efficiencies while providing a more complete view
of an organisation often spanning multiple sites,
geographies and suppliers.
As organisations begin to understand and appreciate
the value of different management systems all
speaking a common language, it will be organisations
and - and in turn the consumer - who stand to be the
true beneficiaries.
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Implications: Organizational context

Organisations will need to determine the external and
internal factors that are relevant to their purpose and
that affect their ability to achieve the intended results
of the management system.
This may have implications for the design of the
management system and the alignment of strategy and
structure within organisations.
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Implications: Leadership
There are now more areas where top management need
to demonstrate their involvement and engagement with
the quality management system, such as:
Ensuring integration of QMS requirements into the
organisations processes.
Promoting awareness of the process approach.
Assuring the QMS achieves its intended results.
Supporting other relevant management roles to
demonstrate their leadership.
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Implications: Risk
Organisations need to identify risks to ensure that

policy and objectives can be achieved. For significant
risks measures need to be put in place to manage them.
This is an extension of the current planning
requirements. This strengthens the need for
organisations to look ahead so that the management
system delivers for the future as well as the present.
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Implications: Change
The organisation will need to manage change through

the management system and also maintain the system
while the organisation changes itself.
This is recognition that the management system is both
the controlling mechanism of the organisation and part
of it at the same time.
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Implications: Performance
Performance requirements include the preparation of

performance analysis as a significant input into the
management review process.
This will strengthen the link between management
system performance and the quality of product/service
delivery.
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Implications: Integration
The introduction of high level common text and
structure for all management systems standards
through the adoption of Annex SL will help
organisations using more than one standard to align
aspects and/or integrate elements or the whole of their
management system.
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ISO 9001:2015 Certification Transition Timeline
2015
2016
2017
2018
September 2015
Published ISO 9001
Standard
September 2015 start of a probable 3 years

transition period to September 2018 (rules &
guidance tbc)
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What next?
How significant are the changes for me and
my organisation?
What should my organisation be doing
next?
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How significant are the changes to my organisation?
Level of
involvement
of top
management
Maturity of
your QMS
Dependent
on your
organisations
circumstances
Implications
for your
organisation
Approach to
risk
management
Use of a
process based
approach
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Questions
What areas represent the
biggest change for your
organisation?
What do you see as the
biggest challenge in your
organisation for transition
to ISO 9001:2015?
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Defining your requirements

Now you have an overview of the changes,
which pieces are missing in your organisation?
Knowledge
management
process
Top management
engaged and
Involved in the QMS
Risk management
process
Context of
your
organisation
Integrated
management
system
Process-based
approach
Systematic
change
management
Developing your transition plan with LRQA

LRQA's experienced sector experts will develop a bespoke training
package for your organisation.
Competency
Development
Knowledge
Development
LRQA Training Solutions
ISO/DIS 9001:2014 Appreciation and Interpretation

(2 Days)
Understanding
ISO/DIS 9001:2014
for Management
(1 Day)
Understanding
ISO/DIS 9001:2014
for Procurement &
Logistics
(2 Days)
ISO 9001:2015 TrainingTraining-Led

Transition Programme
(Training & Facilitated
Workshop)
10 Days, 4 Modules,
delivered over 3 months.**
ISO 9001:2015
QMS Internal
Auditor
Refresher
Training **
(1 Day)
Understanding
ISO/DIS 9001:2014
for Human
Resource
Management
(2 Days)
ISO 9001:2015
QMS Internal
Auditor
Training **
(2 Days)
** Under development, be available upon approval from Global Training, UK

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LRQA Training Information
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Gap Analysis
Which gap analysis is best for me and my organisation?
Gap Analysis Light
Identify areas for improvement

relating specifically to the
changes in the DIS.
Giving you a gap analysis report
to support your transition.
Full Gap Analysis
Looks at your management

system in terms of Annex SL and
all of the changes relating to the
DIS.
The resulting analysis report will
make you an expert on the
implications of the revisions for
your organisation.
Achievements
Final outcomes for your organisation
UNDERSTAND
An in-depth understanding
of what your organisation
needs to address to meet the
new
and
enhanced
requirements
of
ISO
9001:2015.
TRANSITION
A transition plan and process

that takes you and your
organisation to being LRQA
certified
against
ISO
9001:2015.
ADVANTAGE
You and your organisation

have the opportunity to be
pioneers in implementing
ISO 9001:2015 and to gain
competitive
advantage
through
improved
performance.
Summary
Much of your existing system will, no doubt, meet large parts of the
new standard so you will not be starting from scratch.
You have three years to transition to the new standard from the
publication date.
Remember, it is your QMS that needs to be upgraded to deliver

tangible benefits to your organisation.
The whole concept of having a QMS is to take preventive action to

manage the risk to the on-going success of your organisation in an
ever changing world.
If you would like additional help such as a Gap Analysis against the
new standard, on site training of your existing auditors, or want us to
deliver a management briefing, LRQA is here to help.
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Join the discussion
@LRQA
www.linkedin.com/company/lrqa
www.lrqa.com/isostandardsupdate
enquiries@lrqa.com
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Useful external resources
www.iso.org
International Organization for Standardization
www.iioc.org
International Independent Organisation for

Certification
www.irca.org
International Register of Certified Auditors
www.thecqi.org
Chartered Quality Institute
www.iaf.nu
International Accreditation Forum
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We can help with our unique service offerings

Business Assurance from LRQA helps you to
manage your systems and risks to improve and
protect the current and future performance of
your organisation
Contact LRQA through our website for more information and
professional support to successfully move into this new era for ISO
9001 and other management system standards with clarity and
ease.
www.lrqa.com.sg
reducing risk
Foong Wai Kiong

Business Centre Manager
LRQA Singapore
T +65 6891 7288 E wai-kiong.foong@lr.org
www.lrqa.com.sg
LRQA Singapore
460 Alexandra Road, #28-01/02, PSA Building, Singapore 119963
reducing risk
Lloyds Register and variants of it are trading names of Lloyds Register Group Limited, its subsidiaries and affiliates.
Copyright Lloyds Register Quality Assurance Limited 2014. A member of the Lloyds Register group.

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ISO/DIS 9001:2014 and the shape of things to come

Lloyds Register Quality Assurance (Singapore)

Established in 1985 by Lloyds Register (LR).

Objectives of the seminar

Provide an overview of what is new to the standard and what has

Help you identify the potential implications for your organisation

Help you identify what you need to do to plan for your

Provide you with a useful reference guide.

The current timescale to publication

Please note that these timescales are subject to change.

What does ISO/DIS 9001:2014

How significant are the changes to my organisation?

Now states intended result(s)

Essentially these are requirements

3: Terms and Definitions

Terms and Definitions

Some amendments and clarifications

Greater area of focus, integral to business processes and

Greater area of focus on risk(s) and performance

Clarification on approach and structure, removal of

The role of Annex SL in the

Whilst the structure and terminology has changed, there is no

Annex SL - Every ISO standard now has to demonstrate

Annex SL - The standard clauses

ISO 9001: 2015

3. Terms and Definitions

3. Terms and Definitions

4. Quality Management Systems

4. Context of the organization

6. Planning for the quality management system

8. Measurement, Analysis &

What is risk based thinking?

Risk-based thinking is something we all do automatically and often subconsciously.

How does risk relate to ISO 9001 - the main objectives

To provide confidence in the organisations ability to consistently provide

To enhance customer satisfaction.

The concept of risk in the context of ISO 9001 relates to

Source - ISO/TC 176/SC 2/WG23 N065

Risks & Opportunities A simple example

Risks & Opportunities A simple example

Risks & Opportunities a simple example

Now states intended result(s)

Essentially these are requirements

3: Terms and Definitions

Terms and Definitions

Some amendments and clarifications

Greater area of focus, integral to business processes and

Greater area of focus on risk(s) and performance

Clarification on approach and structure, removal of

Whats new? Clauses 1, 2, 3

Now states intended result(s)

Clause 2: Normative references

Clause 3: Terms and definitions

Terms and definitions are still

Whats new? - Clause 4 onwards becomes the HLS

The High Level Structure (HLS) - Annex SL - provides a set

Whats new? - Clauses 4 onwards becomes the HLS

Operational planning and

Release of products and

Whats new? - Clauses 4 onwards becomes the HLS

Whats new? - Clauses 4 onwards becomes the HLS

Schematic Presentation of a Single Process (Ref: ISO/DIS 9001:2014)