Understanding the changes to ISO 9001:2015

transition
successfully

ISO 9001:2015
How to Make a Smooth Transition to ISO 9001:2015
Understanding the changes to ISO 9001:2015

INTRODUCTION
ISO 9001 is an internationally recognised standard for Quality Management and one of the most widely used
management tools in the world today. The International Organisation for Standardization (ISO) has revised the ISO
9001:2008 standard and significant changes have been made to both its structure and its contents. The purpose of
this guide is to help quality professionals to understand the key aspects of the revised ISO 9001:2015.

WHY HAS THE ISO 9001 BEEN REVISED?

Much has changed in the world since 2000; the global economic recession, financial crisis, increasing global
competition and technological advancements in the workplace, is changing the environment facing most
companies today.

Companies have had to adapt in these challenging times; ISO standards have also had to adapt to address the
changes in the business world. The revisions in ISO 9001:2015 will

Bring a fresh perspective and approach to the standard

Place emphasis on risk-based thinking, change management and organisational knowledge
Maintain relevance within the complex business world organisations operate in
Integrate with other management systems, such as ISO 14001
Provide a consistent foundation for the next 10 years
Ensure the new standard reflects the needs of service providers
Enhance an organisations ability to satisfy its customers

WHAT ARE THE MOST SIGNIFICANT CHANGES?

The changes can be divided into two areas. First those related to the Annex SL introduction and second those
specifically related to the revision of ISO 9001 standard which includes:

Explicit requirement for Risk-Based thinking

Less emphasis on documents
Better application for services (vs products)
Boundary definition of the QMS
Emphasis on organisational context
Increased leadership requirements
More emphasis on customer satisfaction outcomes
Objectives must include reference to who, what, when
Change Management/planning of changes
Explicit reference to knowledge management
Operational planning includes addressing risks
Greater emphasis on processes achieving requirements for goods or services and customer satisfaction
Understanding the changes to ISO 9001:2015

ANNEX SL
The Annex SL follows the well know PDCA cycle and processes approach from section 4 to section 10, in an order
that is consistent with organisational planning and process management.

4 5 6 7 8 9 10

CONTEXT
PERFORMANCE
OF THE LEADERSHIP PLANNING SUPPORT OPERATION IMPROVEMENT
EVALUATION
ORGANISATION

Understanding Actions Monitoring,

Leadership Operational Non conformity
the to address measurement
and Resources planning & corrective
organisation risks and analysis
commitment & control actions
and its context opportunities & eval.

Needs & Determination

Quality
expectations of requirements Continuous
Quality policy objectives Competence Internal audit
of interested for prod. improvement
& planning
parties & services

Roles, Design & devel.

Scope Planning of Management
responsibilities Awareness of products
of the QMS changes review
& authorities & services

Control of
QMS & its externally
Communication
processes proc.prod. &
services

Production
Documented
& service
information
provision

Release of
products
ANNEX SL & services
The Annex SL defines the framework for a generic
Management System Standard. All new ISO
management system standards will adhere to this Non conforming
processes
framework and all current ISO management system prod.
standards will migrate at their next revision. & services

The Annex SL framework provides identical structure, text and common terms and definitions for management
system standards. This will ensure consistency among future and revised management system standards and make
integrated use simpler.

The number of sections has expanded to ten from the standards eight with additions for Performance Management
and Evaluation. The high level structure contains 3 introductory clauses and 7 basic clauses which will be common
to all management systems standards. Each ISO management system will require the addition of discipline-specific
requirements such as environmental, health and safety, service management, food safety, business continuity,
information security and energy management. Annex SL allows for discipline-specific requirements of each ISO
standard, to be detailed in clause 8 Operation.
Understanding the changes to ISO 9001:2015

ANNEX SL STRUCTURE
The revised ISO 9001 and ISO
14001, as well as the new ISO
45001 will all be based on Annex
SLs high level structure.
Clause 1 SCOPE

Introductory
Clause 2 NORMATIVE REFERENCES
clauses

Clause 3 TERMS AND DEFINITIONS

Clause 4 CONTEXT OF THE ORGANISATION

Clause 5 LEADERSHIP

Clause 6 PLANNING
Basic clauses,
common to all 7
Clause SUPPORT
management
systems standards
Clause 8 OPERATION

Clause 9 PERFORMANCE EVALUATION

Clause 10 IMPROVEMENT

As a result of the above amendments the new standard is easier to read, understand and arranged more logically.
Once a company has an understanding of the new terms and concepts it is a significant improvement on previous
versions.
Understanding the changes to ISO 9001:2015

Clause 4 CONTEXT OF THE ORGANISATION

Clause 4 is the most important element of the new standard as this section forms the building blocks of an
organisations entire Quality Management System.

A number of subsequent
Clause 4 consists of four sub-clauses: 4.3 requirements in the ISO
Determining
the scope of the 9001:2015 standard rely
management on the outputs from
system
4.1 4.2 clause 4.1 and 4.2.
Understanding Understanding 4.4
the organisation the needs and The
and its context expectations of management
interested system
parties

4.1 UNDERSTANDING THE ORGANISATION AND ITS CONTEXT (STRATEGIC PLANNING)

This clause requires the senior management team to develop a business strategy by starting with a complete
evaluation of the organisations current situation both internal and external, positive or negative, that are relevant to
its purpose and most importantly, that have the ability to impact the quality management systems intended result.

DIAGRAM OF STRATEGIC PLANNING

EXTERNAL ENVIRONMENT INTERNAL ENVIRONMENT

Values
Political

Culture
Economic

Strategic Knowledge

Cultural
Planning
Performance

Technological
Management

Competitive
Environment
HR
Understanding the changes to ISO 9001:2015

4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES

The concept of interested parties is a new clause in the standard. It is now a requirement for the senior management
team to consider and determine all interested parties and their requirements.

Examples of interested parties include:

MANAGER CUSTOMERS

INDUSTRY
SUPPLIERS
GROUPS

THE BUSINESS

OWNERS AND
GOVERNMENT
SHAREHOLDER

COMMUNITY EMPLOYEES

4.3 DETERMINING THE SCOPE OF THE MANAGEMENT SYSTEM

Determining the scope of the Quality Management System (QMS) has always been a critical requirement of ISO
9001. The difference now is when determining the scope the organisation needs to take into account its:

a. external and internal issues referred to in 4.1

b. requirements of relevant interested parties referred to in 4.2
c. products and services.

It is now also a specific requirement to document the scope of the quality management system (QMS) and to
include justifications where it is not possible to meet specific elements of ISO 9001.

4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES

Quality Management System - New Requirements

Needs to be Determine Risk Change to Documented

Processed Based & Opportunities Information

Existing standard operating procedures, work instructions, flowcharts and forms are still valid!

No longer a requirement for the ISO 9001 Quality Manual!

Understanding the changes to ISO 9001:2015

Clause 5 LEADERSHIP

Clause 5 consists of three sub-clauses:

New standard does not

5.3 require appointing a quality
5.1 Organisational
roles, management representative
Leadership and 5.2
commitment responsibilities
Policy and authorities

5.1.1 General

5.1 Leadership and commitment 5.1.2 Customer focus

5.2.1 Establishing the Quality Policy

5. LEADERSHIP 5.2 Policy
5.2 Communicating the Quality Policy

PLAN 5.3 Organisational roles, responsibilities and authorities

This clause is very much similar to Clause 5.1 in ISO 9001:2008 but many new requirements have been added. The
standard now requires the leadership team to have a great involvement in the QMS and to demonstrate leadership
and commitment to the QMS. Other leadership duties required by the standard are detailed below:

Quality Policy &

Strategy Objectives are developed QMS is used to Advocate Process
Accountable for QMS
& Vision and understood within manage business Approach
the company

Leadership

Communicating the Ensuring that the QMS Assist management

Encourage improvement
Resources are available importance of conforming produces the expected team in showing QMS
activities
to QMS outcomes leadership
Understanding the changes to ISO 9001:2015

Clause 6 PLANNING

Clause 6 consists of three sub-clauses:

6.1
Actions to 6.2
address risks and Management
opportunities system objectives
and planning to
achieve them

6.3
Planning of
Changes

6.1 Actions to address risks and opportunities

6.PLANNING 6.2 Management system objectives and planning to achieve them

PLAN 6.3 Planning of Changes

6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES

The new ISO 9001:2015 has removed preventive action as a requirement and has incorporated an explicit requirement
for risk & opportunity management into a quality management system. The new standard expects companies to
identify and address business risks affecting product and service requirements and to address opportunities for
improvement based on the risk analysis. An effective risk management and compliance program will be critical for
successful certification to the new version. A formal risk management system approach such as ISO 31000 will not
be required for SMEs or low risk organisations.

6.2 MANAGEMENT SYSTEM OBJECTIVES AND PLANNING TO ACHIEVE THEM

No changes!

6.3 PLANNING OF CHANGES

The new version of the standard requires the organisation to take a planned approach to change. The process
involves considering the:

Potential
consequences of
the change
Purpose of the Availability of
change resources

Allocation of
responsibilities
Understanding the changes to ISO 9001:2015
Clause 7 SUPPORT
Clause 7 consists of five sub-clauses:
7.1 Resources
7.SUPPORT 7.2 Competence
PLAN 7.3 Awareness
7.4 Communication
7.5 Documented information
This clause requires an organisation to determine the
support needed to establish, implement, maintain and
continually improve their management system and to
meet their goals and objectives.
A lot of the requirements in the ISO 9001:2015
standard Clause 7 are similar to the ISO 9001:2008
clause requirements. The major differences are that an
organisation must consider;
Capabilities and constraints on its existing internal
resources as well as what needs to be sourced from
external providers.
Human factors when considering its environment for
the operation of its processes (social, psychological
and physical factors).
Provision of resources for monitoring and
measurement.
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the Operation of Processes
7.1.5 Monitoring and Measuring Resources
7.1.6 Organisational Knowledge
7.1.5.1 General
7.1.5.2 Measurement traceability
7.5.1 General
7.5.2 Creating and updating
7.1.3 Control of documented information
Organisational Knowledge is a new requirement of
the new standard. Its aim is to ensure an organisation
will take steps to capture and preserve knowledge and
learning, which is necessary for the effective operation
of their processes and for ensuring the conformity of
their products and services.
The new term Documented Information replaces
previously used terms such as documents, documentation
and records. This is to reflect current technology as
data, documentation and records are now frequently
processed electronically. Documents may be in any form
or type of medium, for example:
paper
magnetic
electronic or optical computer disc
photograph
master sample
Understanding the changes to ISO 9001:2015

Clause 8 OPERATION

8.1 Operational
Clause 8 consists of planning and
seven sub-clauses: control

8. OPERATION
8.2.1 Customer communication
8.2 Requirements
8.2.2 Determination of requirements
DO for products and
for products and services
services
8.2.3 Review of the requirements for
products and services
8.3.1 General
8.3 Design and
8.2.4 Changes to requirements for
8.3.2 Design and development
products and services
development planning of products and
services
8.3.3 Design and
development inputs 8.4.1 General
8.3.4 Design and 8.4 Control of
development controls externally provided 8.4.2 Type and extent of control
processes, products
8.3.5 Design and 8.4.3 Information for external
and services
development outputs providers
8.3.6 Design and
8.5.1 Control of production and service
development changes
provision
8.5 Production and
service provision 8.5.2 Identification and traceability

8.5.3 Property belonging to customers

or external providers
8.6 Release of
8.5.4 Preservation
products and
services 8.5.5 Post-delivery activities

8.5.6 Control of changes

8.7 Control of
nonconforming
outputs

This section is the largest section of the ISO 9001:2015 standard and is the core of the management system requirements.
Important changes are as follows:

Establish criteria for the processes

Implement control of the processes, in accordance with the criteria
Keep documented information to the extent necessary to have confidence that the processes have been carried
out as planned
Control planned changes and review the consequences of unintended changes, taking action to mitigate any
adverse effects
Ensuring outsourced processes are controlled.
Understanding the changes to ISO 9001:2015

Clause 9 PERFORMANCE EVALUATION

Clause 9 consists of three sub-clauses:

9.1 9.3
Monitoring, 9.2 Management
measurement, Internal review
analysis and audit
evaluation 9.1.1 General

9.1.2 Customer satisfaction

9.1.3 Analysis and evaluation

9.1 Monitoring, measurement, analysis and evaluation

9. PERFORMANCE EVALUATION 9.2 Internal audit

9.3 Management review

CHECK
9.3.1 General

9.3.2 Management review input

9.3.3 Management review output

In clause 9 organisations must identify what, when, and the method of monitoring and measurement. Documented
information must be retained as evidence of results.

Internal audits are also part of this process to ensure the management system conforms to the requirements of the QMS.

The final step, management review, looks at whether the management system is suitable, adequate and effective.
One of the new requirements is the requirement of the management team to incorporate a review of the strategic
direction of the business, operating environment and interested parties.

Clause 10 IMPROVEMENT 10.2

Nonconformity 10.3
10.1 and corrective Continual
Clause 10 consists of three clauses: General action improvement

10.1 General

10. IMPROVEMENT 10.2 Nonconformity and corrective action

10.3 Continual improvement

ACT

Clause 10 addresses nonconformity, corrective action and continual improvement

of an organisation. This enables an organisation to continually improve the
suitability, adequacy and effectiveness of its management system.

The requirements here are very much similar to the ISO 9001:2008 version. The
main difference is the removal of preventive action as this has been replaced by
risk management.
Understanding the changes to ISO 9001:2015

MANAGING YOUR TRANSITION TO ISO 9001:2015

Those businesses currently registered to ISO 9001:2008 have 3 years to make the transition. You can decide when
to transition, but we would recommend that you transition at the time of your three year surveillance audit. The
deadline to move to ISO 2015 Certification is by September 2018. This means that, after the end of September 2018,
an ISO 9001:2008 certificate will no longer be valid.

2015 2016 2017 2018

September 2015 Expected transition
New ISO publication Between 2-3 years

September 2015
Start of three year transition period to September 2018

COMPANIES USING ISO 9001:2008 ARE RECOMMENDED TO TAKE THE FOLLOWING ACTIONS TO
ENSURE A SMOOTH TRANSITION:

1 Purchase the new ISO 6 Provide appropriate training

9001:2015 standard and awareness for your core
team (Quality Managers,
Internal Auditors)

2 Set up a project team 7 Update the existing quality

management system (QMS)
and make changes to your
documentation to reflect the
new structure (as necessary)

Identify organisational gaps Highlight the changes as

3 8
which need to be addressed to opportunities for improvement
meet new requirements

Develop an implementation Conduct an internal audit

4 9
plan

Implement the new Where applicable, liaise with

5 10
requirements on leadership, your Certification Body for
risk and context of the transition arrangements
organisation
Understanding the changes to ISO 9001:2015

WHAT BENEFITS WILL ISO 9001:2015

BRING TO ORGANISATIONS?
Improves customer
confidence and
satisfaction in
your products and
Prevention and
services
improvement
Defined criteria
will become the
for company
mainstays instead
objectives and their
of continual
fulfillment Work in a more efficient
problem solving way as all your processes
Greater and resolution You have greater will be aligned and
accountability & understood by everyone
flexibility in the
involvement in in the business - this
way to implement increases productivity
the QMS by your
the standard Highlights non- and efficiency,
leadership team Quality bringing internal costs
conformances &
Management down
reduce errors in
and continuous
product quality
improvement will
and services while
be at the very core The revision
ensuring customer
Your QMS will of your business You chose the highlights the
satisfaction
be aligned and amount and importance of
integrated with nature of the efficient risk
your business Identification of documentation that management
strategy interested parties & is required! of outsourced
their requirements Improve activities
will ensure you operational
consistently
meet their needs performance and
and may lead to increase profits
Identification further business Provides the tools
and management opportunities necessary to
of business risks anticipate and deal
ensures compliance with future changes
and operational The new common from a risk-based
efficiency structure and core perspective
text makes it easier Establishes a
to implement company culture of
multiple, integrated Minimising improvement
Identification management documentation
systems also makes it easier Stronger measuring
of business
for individual and monitoring
opportunities
employees to absorb requirements will
will contribute and understand increase business
to bottom line requirements, which efficiency
improvements Fewer ultimately ensures
recommended their use Addresses supply
requirements to chain management
implement the more effectively
standard
The focus on risks
Provide the tools
& opportunities
to satisfy customer
will establish a
requirements
proactive culture
Understanding the changes to ISO 9001:2015

HOW CAN CGBC SUPPORT YOU IN YOUR TRANSITION?

ISO 9001:2015 GAP ANALYSIS TOOL AND GAP ANALYSIS ON SITE

Our gap analysis tool will allow you to compare your organisations current practices and processes with the new
ISO 9001 standard. This comparison will identify the gaps (the areas that fall short of the standard). Once you know
where to focus your attention, you can begin to make the changes that are needed to comply with the new ISO
9001 2015 standard.

AWARENESS SEMINARS AND WORKSHOPS

This course will help you find out what you need to know about transitioning to the new ISO 9001:2015 standard.
You will discover more about the changes and how these will affect your organisation so you can start putting
transition arrangements in place.

INTERNAL AUDITOR TRAINING

This course will help you stay at the forefront of QMS strategy. By attending you will transform your existing
auditor skills to ISO 9001:2015.
Building on your knowledge you will develop the skills to audit against the changing landscape of ISO 9001:2015
Quality Management System (QMS).Youll gain the practical knowledge needed to build your auditing skills.
A series of deep dive workshops, which focus on auditing risk, leadership, external provision and facilitated
action are also available for you to attend.

REVISED 2015 STANDARDS TRAINING RISK MANAGEMENT TRAINING

Understanding the changes to ISO 9001:2015

KEY STEPS FOR A SUCCESSFUL TRANSITION

Dont delay start working on your transition today

1 Talk to CGBC Irelands Leading ISO Consultant

Discuss your challenges and timelines
Review the latest videos and guidance documents on the CGBC website for background information

2 Attend a CGBC Training Course

Understand the new requirements faster and in greater detail by attending our training courses; from
introduction through to deep dive modules which explain the new areas in greater depth

3 Communicate with your organisation

Talk to your leadership team about the new requirements
Communicate the revision to your wider organisation to gain buy in
Send regular updates on progress

4 Set up an Internal Project Team

Download CGBC transition toolkit which will guide you through the transition
Conduct a GAP analysis against your current system
Create an implementation plan and monitor progress
Take a fresh look at your QMS/EMS/QEHS
Implement the new requirements on leadership, risk and context of the organisation
Change your documentation to reflect the new structure

5 Gap Analysis
CGBC can conduct a GAP analysis to help you Identify organisational gaps which need to be addressed to meet
new requirements
CGBC will develop an implementation plan

6 CGBC will assist you to implement the new requirements on leadership, risk and context of the organisation

7 Provide appropriate training and awareness

8 CGBC will update the existing quality management system (QMS) and make changes to your documentation to
reflect the new structure (as necessary)

9 CGBC will conduct internal audits cycle

10 CGBC will attend the certification audit to support you on your ISO certification 2015 journey
Understanding the changes to ISO 9001:2015

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