ISO 9001:2015 - What does it mean for your organisation?

Cholid Bafagih

30 October 2014

Improving performance,
reducing risk
Venue safety and other arrangements

– Exits, alarms, breaks, phones etc.

Improving performance,
reducing risk
Introduction

Improving performance,
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What we do

World class assessment and training

services
– LRQA provides independent assurance
including assessment, certification,
validation, verification and training
across a broad spectrum of standards
and schemes.

– We deliver our services to companies

operating in all of the major sectors
worldwide.

– LRQA is represented on all of the major

ISO technical committees that are in the
process of shaping the revised standards.

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 Objectives of the day

This workshop will:

1. Introduce you to Annex SL, the new high level structure (HLS) of all
ISO Standards.

2. Help you identify the potential implications for your organisation

of the changes to ISO 9001.

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

organisation’s transition to ISO 9001:2015.

4. Provide you with a useful reference guide.

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Aim of ISO 9001

Over 1.2 million ISO 9001 certificates globally

Tangible Customer
Product/ improvements requirement
Continual Customer
service based on to tender –
improvement satisfaction
quality robust systems licence to
and processes trade

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 The current timescale to publication

June December April May March September Proposed

2012 2012 2013 2014 2015 2015 Transition
Period
Draft design Approved CD for ISO/DIS Proposed Proposed
spec. and design spec comment 9001:2014 FDIS ISO 3 years from
WDO and WD1 and ballot published publication 9001:2015 standard
for publication publication
comment
(3 months)

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Please note that these timescales are subject to change. reducing risk
What does ISO/DIS 9001:2014
mean for me and my
organisation?

Improving performance,
reducing risk
How significant are the changes to my organisation?

Dependent on
Implications for
your
your
organisation’s
organisation
circumstances

Improving performance,
reducing risk
ISO/DIS 9001:2014
Key areas of change to documented requirements

Clause No: Title Item Change

1: Scope Scope Now states “intended outcome(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 Context of the New requirements

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

Management Review Greater area of focus

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

9. Performance Evaluation
8. Measurement, Analysis &
Improvement 10.Improvement

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Management of Risk,
Opportunity and Change

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How does risk relate to ISO 9001 - the main objectives

– To provide confidence in the organisation’s 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

Improving performance,
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The ALARP approach to Risk Management

‘As Low as Reasonably Practical (ALARP)’ approach

Risk

Risk is justifiable only in

Unacceptable Region exceptional circumstances

Tolerable only when risk

Tolerable Region reduction is not practicable or
the cost exceeds the benefits

Generally Acceptable Region

Insignificant Risk Improving performance,

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What’s new?
The requirements of each clause

Improving performance,
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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 outcome(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 Context of the New requirements

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

Management Review Greater area of focus

10: Improvement Continual Improvement Clarification on approach and structure,Improving
removal performance,
of
preventive action reducing risk
What’s new? Clauses 1, 2, 3

Clause 1: Scope Now states “intended outcome(s)”

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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What’s 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

4. 5. 6. 7. 8. 9. 10.
CONTEXT OF LEADERSHIP PLANNING SUPPORT OPERATION PERFORMANCE IMPROVEMENT
THE EVALUATION
ORGANIZATION

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Changes required by
ISO/DIS 9001:2014

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Clause 4

PLAN

4.
5. 6. 7.
CONTEXT OF THE
LEADERSHIP PLANNING SUPPORT
ORGANIZATION

Understanding of Actions to address

Leadership and
the organization and risk and Resources
commitment
its context opportunities

Needs and Quality objectives

expectations of Quality policy & planning to Competence
interested parties achieve them

Roles,
Scope of Planning of
responsibilities and Awareness
management system changes
authorities

QMS and its

Communication
processes

Documented
information
Clause 5

PLAN

4.
5. 6. 7.
CONTEXT OF THE
LEADERSHIP PLANNING SUPPORT
ORGANIZATION

Understanding of Actions to address

Leadership and
the organization and risk and Resources
commitment
its context opportunities

Needs and Quality objectives

expectations of Quality policy & planning to Competence
interested parties achieve them

Roles,
Scope of Planning of
responsibilities and Awareness
management system changes
authorities

QMS and its

Communication
processes

Documented
information
Clause 6

PLAN

4.
5. 6. 7.
CONTEXT OF THE
LEADERSHIP PLANNING SUPPORT
ORGANIZATION

Understanding of Actions to address

Leadership and
the organization and risk and Resources
commitment
its context opportunities

Needs and Quality objectives

expectations of Quality policy & planning to Competence
interested parties achieve them

Roles,
Scope of Planning of
responsibilities and Awareness
management system changes
authorities

QMS and its

Communication
processes

Documented
information
Clause 7

PLAN

4.
5. 6. 7.
CONTEXT OF THE
LEADERSHIP PLANNING SUPPORT
ORGANIZATION

Understanding of Actions to address

Leadership and
the organization and risk and Resources
commitment
its context opportunities

Needs and Quality objectives

expectations of Quality policy & planning to Competence
interested parties achieve them

Roles,
Scope of Planning of
responsibilities and Awareness
management system changes
authorities

QMS and its

Communication
processes

Documented
information
Changes required by
ISO/DIS 9001:2014
Clause 8: Operation

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Clause 8…

DO 8.
OPERATION

Operational planning and control

Determination of requirements for

products and services

Design and development of

products and services

Control of externally provided

products and services

Production and service provision

Release of products and services

Control of nonconforming process

outputs, products and services

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Changes required by
ISO/DIS 9001:2014

Clause 9: Performance evaluation

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Clause 9

CHECK
9. PERFORMANCE
EVALUATION

Monitoring,
measurement, analysis
and evaluation

Internal audit

Management review

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Changes required by
ISO/DIS 9001:2014
Clause 10: Improvement

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Clause 10…

ACT 10.
IMPROVEMENT

General

Nonconformity
and corrective
action

Continual
improvement

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What next?
How significant are the changes for me
and my organisation?
What should my organisation be doing
next?

Improving performance,
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How significant are the changes to my organisation?

Level of
involvement
of top
management
Approach to
Maturity of
risk
your QMS
management

Dependent
Implications Use of a
on your for your process based
organisation’s organisation approach
circumstances

Improving performance,
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How can LRQA help me?

Not sure where to Need help engaging Need help to get

start? your leadership your colleagues up
team? to speed?

• Training will help • A bespoke • Our in-house or

you identify the training course public training
key areas of for your top courses for
change that are management will Internal Auditors
relevant to you help ensure that will give them
• A gap analysis your organisation the knowledge
will look at your is meeting the and skills they
existing QMS in explicit strategic need to perform
terms of how it requirements of effective internal
meets the ISO/DIS ISO/DIS 9001:2014 audits that meet
9001:2014 the requirements
requirements of ISO/DIS
9001:2014

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Slide 35

c3 "Next Steps" slide added.

covslj, 20/01/2011
Summary

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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 and needs to be designed 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.

Improving performance,
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LRQA at a glance
Independence
First Ever:
LRQA holds United Kingdom
Accreditation Service (UKAS)
accreditation number 001 as
the first ever certification
body for both ISO 9001
(quality) and ISO 14001
(environmental) services
Recognition
Recognised by 50+
accreditation bodies
worldwide
Technical Excellence
Shaping the Industry:
Chair of the IIOC
Chair of the FFSC
Board Member of IETA
Vice President of DIA
Member of ISO and GFSI
Technical Committees
Verification Partner of CDP
Best in Class
BT has won top accolades
from ACCA (Association of
Chartered Certified
Accountants) for their LRQA
verified Sustainability
Reporting
Innovation
We build and deliver
customised audit
programmes for
organisations like Mars to
add an additional level of
assurance against client-
specific criteria
Public Benefit
A Greener Planet
LRQA has verified around
1bn tonnes of CO2 under the
EU ETS. Assuring
organisations’ emissions are
appropriately monitored and
reported thereby enables
their management and
reduction
Adding Value to Society
LRQA verified South Asia’s
first certified emission
reductions under the United
Nation’s PoA framework,
providing 57000 stoves to
Bangladeshi families
First Ever
In the early 1990’s, LRQA
delivered the first ever
Environmental Assurance
Statement to Norsk Hydro
Scale
Global Reach - Local Focus
45000+ clients in
120+ countries
60000+ certificates issued
From Farm to Fork
5000+ food sector
organisations from the
world’s best known brands,
to the smallest suppliers
choose LRQA for their food
safety assurance services
Size of Savings
LRQA’s environmental insight
saved Shanghai Shipbuilding
£1.27m
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

Improving performance,
reducing risk
 Cholid Bafagih
Climate Change and Sustainability Manager
E: cholid.bafagih@lr.org
T: +62 21 5760868
F: +62 21 5760861

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