Updates on CD/ISO

9001:2015
Presented by Zainab Ibrahim, Senior Auditor,
TUV SUD PSB Pte Ltd
30th January 2014

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Corporate Presentation

Slide 1

Agenda

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About ISO 9001 & the Revision

Timeline

Annex SL - High Level Structure

3.

Significant Changes

What organization can do?

About SO 9000 Standard

ISO 9001 Quality Management System (QMS) Standard

Users over 1 million registered organizations
Aims of the QMS Standard

ISO 9000 Family of Standards

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Revision History

1987

Quality Assurance - 20 Elements

1st Released

1994

20 Elements
Minor Change

2000

Quality Management - Process Approach

Major Change

2008

Process Approach
Minor Change

2015

High Level Structure

Revision Planned - Major Change

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ISO 9001:2015 Timeline

2013

2014

2015

May 2013 CD
(Committee Draft)

+ Transition period
for certification

February 2014 DIS

(Draft International
Standard)

February 2015 FDIS

(Final Draft International Standard)

September 2015 Published IS

(International Standard)
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Reasons For The Changes

Demand for a Common Format and Language that is aligned

between those standards
Decrease the emphasis on Documentation
Increase the emphasis on Achieving Value for the Organization
and its customers
Increase emphasis on Risk Management to achieve objectives

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ISO 9001:2015 Revision

Annex SL - High Level Structure

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ISO /IEC Directives, Part 1

The ISO/IEC Directives define the

basic procedures to be followed in the
development of International Standards
and other publications
Mandated by ISOs Technical
Management Board (TMB)

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Annex SL

Annex SL
High level structure, identical core text and common terms and
core definitions for use in all Management System Standards
Enhance the consistency and alignment of different management
system standards

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Annex SL

Organizations who implement a single system addressing multiple

standards (e.g. QMS, EMS, ISMS etc) will see the most potential benefit

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Applying Annex SL to ISO 9001:2015

The objective is to develop the revised ISO 9001 standard using the
new structure as the foundation.
TC 176/SC2 plays an active role in ISOs Joint Technical Coordination
Group that is responsible for the development of Annex SL and any
difficulties in applying Annex SL will be referred back to this group and
to ISO/TMB.

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Annex SL

The high level structure and common text without ISO 9001:2015
management specific text is public information
It can be found at www.iso.org/directives

Please note that Annex SL on its own should not be used to make changes to your management
system

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ISO 9001: 2015?

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Abteilung:

13

High Level Structure (HLS)

1.
2.
3.
4.

Scope
Normative references
Terms and definitions
Context of the organization
Understanding the organization and
its context
Needs and requirements
Scope
Management System
5. Leadership
General
Management commitment
Policy
Roles, responsibility and authority
6. Planning
Actions to address risks &
opportunities
Objectives and plans to achieve
them
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7. Support
Resources
Competence
Awareness
Communication
Documented information
8. Operation
Operational planning and control
9. Performance evaluation
Monitoring, measurement, analysis
& evaluation
Internal audit
Management review
10. Improvement
Non conformity and corrective action
Continual Improvement

Annex SL High Level Structure Some Examples

Clause 4.1 Understanding the organization and its context

The organization shall determine external and internal issues
that are relevant to its purpose and that affects its ability to
achieve the intended outcome(s) of its XXX management
system.
Note: XXX = quality, environmental, information security
etc

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Annex SL High Level Structure Some Examples

Clause 4.4 XXX management system

The organization shall determine establish, implement,
maintain and continually improve an XXX management
system, including the processes needed and their interactions,
in accordance with the requirements of this International
Standard.
(Note: This is key to maintaining the process approach,
which will now be embedded in ALL ISO management system
standards)
(Current clause 4.1 of ISO 9001:2008 likely to be incorporated
into this clause).
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Annex SL High Level Structure Some Examples

Clause 4.4 XXX management system

The organization shall determine establish, implement,
maintain and continually improve an XXX management
system, including the processes needed and their interactions,
in accordance with the requirements of this International
Standard.
(Note: This is key to maintaining the process approach,
which will now be embedded in ALL ISO management system
standards)
(Current clause 4.1 of ISO 9001:2008 likely to be incorporated
into this clause).
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Slide 17

CD/ISO 9001:2015
Significant Changes
Please note that since the
contents are under development, there may be further changes

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Quality Management Principles - from 8 to 7 QMP

8 QMP

7 QMP

1. Customer focused
organization
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to
management
6. Continual Improvement
7. Factual approach to decision
making
8. Mutually beneficial supplier
relationship

1.
2.
3.
4.
5.
6.

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Customer focus
Leadership
Engagement of people
Process Approach
Improvement
Evidence based Decision
Making
7. Relationship Management

Slide 19

Significant Changes

a) Redrafting to make the standard more generic and more

easily applicable by service industries.
Explicit reference to goods and services
Revision on measurement equipment and design and
development

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Significant Changes

b) Context of the organization

HLS introduced
Clause 4.1 Understanding the organization and its
context and
Clause 4.2 Understanding the needs and expectations of
interested parties

Identify impacts on planning the quality system

In 9001:2015 the scope is unchanged
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Significant Changes

c) Process Approach
More explicit
Clause 4.4.2 Process approach specifying requirements
considered essential to the adoption of a process approach.

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Significant Changes
Clause 4.4.2 Process Approach
The organization shall apply a process approach
a)Determine the processes
b)Determine the inputs & outputs from each process
c)Determine their sequence and interaction
d)Determine the risks to conformity and customer satisfaction if unintended outputs are
delivered or process interaction is ineffective
e)Determine criteria, methods, measurements and related performance indicators needed
to ensure that both the operation and control of these processes are effective
f) Determine the resources and ensure availability
g) Assign responsibilities and authorities
h) Implement actions required to achieve results
i) Monitor, analyzethese processes ensuring they continue to deliver the intended
outputs
j) Ensure improvement of these processes.

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Significant Changes

d) Risk and Preventive Action

Risk Analysis concepts are introduced
Preventive Action is no longer a clause (8.5.3)

Preventive Action concepts are deployed throughout the

Standard (e.g. New clauses 4.1 and 6.1)
No requirement for formal risk management

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Significant Changes

Clause 6.1 Address Risks and Opportunities

Determine Risks and opportunities that need to be addressed
to:
a.) Assure the QMS can achieve its intended outcomes
b.) achieve conformity & customer satisfaction
c.) Prevent or reduce undesired effects
The organization shall plan actions to address these Risks &
Opportunities and integrate actions into the QMS and
evaluating the effective of actions
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Significant Changes

e) Documented information
HLS adopted without significant change and addition
Document and record replaced by documented information.

No specific requirement for Quality Manual or 6 mandatory

documented procedures.

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Significant Changes

f) Control of external provision of goods and services

Addresses all forms of external provision
Risk based approach to determine type and extent of control

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ISO 9001:2015 Revision

What organizations can do

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I need to ensure my Organization . . .

Knows what is going on and is ready to implement the

new requirements

Takes full advantage of the revision of ISO 9001 to

improve business performance
Remember, dont make any changes yet!

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Organizational Opportunities

Integrate their activities within the scope of multiple

Management System Standards
Decrease the emphasis on documentation when this is not
mandated or does not add value

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Transition Period

The new version is expected to be published by the

September 2015.
A transition period (usually two years) before ISO 9001:2008
officially becomes out of date.

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Slide 31

Stay Tuned!
Additional updates and information will be made available as the
change process proceeds

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Thank you for your attention!

Ms Zainab Ibrahim
TV SD PSB Pte Ltd
Email: [email protected]
Hotline: +65 9366 8611

www.tuv-sud-psb.sg
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