How to manage

the transition
successfully

ISO 9001:2015
TOP MANAGEMENT - QUALITY MANAGERS
TECHNICAL GUIDE

Move Forward with Confidence

2 ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS
TECHNICAL GUIDE

WHAT ARE THE MAIN CHANGES

IN ISO 9001?
PLAN DO CHECK ACT
4
5

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

Actions
Understanding Leadership Resources Operational Monitoring, Non conformity
to address
the and planning measurement & corrective
risks and
organization commitment & control analysis actions
opportunities
and its context & eval.
Competence

Quality policy Quality Determination

Needs & objectives of requirements Internal audit
Awareness
expectations & planning for prod.
of interested & services
parties Roles, Management Continuous
responsibilities Planning of Communication review inprovement
& authorities changes
Scope Design & devel.
of the QMS of products
Documented
& services
information
QMS & its
processes The new model is similar to the previous
Control of one. Although the intention is not to
externally recommend the sequence of
proc.prod. & activities that an organization follows
services in the implementation of a management
system, each organization is free
to interpret the model as it
Production sees fit.
& service
provision

Release of
Clause 1 SCOPE
products
Introductory & services
Clause 2 NORMATIVE REFERENCES
clauses

Clause 3 TERMS AND DEFINITIONS

Non conforming
processes
prod.
Clause 4 CONTEXT OF THE ORGANIZATION & services

Clause 5 LEADERSHIP

Clause 6 PLANNING The high-level structure proposed in Annex SL for all ISO
Basic clauses,
management systems includes, in addition to the usual 3
common to all
management Clause 7 SUPPORT introductory clauses, 7 basic clauses common
systems standards to all management system standards. They are:
Clause 8 OPERATION context of the organization, leadership, planning, support,
operation, performance evaluation and improvement. For
Clause 9 PERFORMANCE EVALUATION
ISO 9001, they will replace current clauses 4, 5, 6, 7 and
8. It follows the well known PDCA cycle and the process
approach from section 4 to 10, in an order that is consistent
Clause 10 IMPROVEMENT
with organizational planning and process management.
 ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS 3
3 TERMS AND DEFINITIONS TECHNICAL GUIDE

Clause 4 CONTEXT OF THE ORGANIZATION

5 LEADERSHIP
4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT
Annex SL has introduced two new clauses related to the context resources, and other issues which could have an impact on the
of the organization:
6 PLANNING Both clauses
FOR require
THE QMSthe organization to objectives of the organization.
determine issues and requirements that may have an impact on the
planning of the QMS and can serve as input for the development of the The context of the organization refers to the business
system. Although reference is made to the determination of requirements environment it is operating in. To do this, it must first decide what
of relevant 8 OPERATION
stakeholders, there are no additional requirements to ensure are the intended results of its QMS and then determine the
that goods and services meet the needs and expectations of external relevant internal and external issues that affect its ability to
entities other than those already identified in ISO 9001:2008. The achieve those results.
organizations top management must be involved directly and actively Understanding the external context can be facilitated by considering
7 SUPPORT
in the clarification of its mission and vision, considering both the internal issues arising from legal, technological, competitive,
and external issues that may affect its ability to achieve the desired market, cultural, social, and economic environments, whether
results. The requirements include the consideration of changes international, national, regional or local. Understanding the internal
and trends, relationships, perceptions and values of
9 PERFORMANCE context can be facilitated by considering issues related to values,
EVALUATION
stakeholders, strategic priorities, the availability of culture, knowledge and performance of the organization.

10 IMPROVEMENT
BUSINESS ENVIRONMENT

EXTERNAL ISSUES

INTERNAL ISSUES
TECHNOLOGICAL
ECONOMIC CULTURE VALUES CULTURAL
INTENDED LEGAL
MARKET
R E S U LT S SOCIAL
COMPETITIVE KNOWLEDGE PERFORMANCE

Note : The concept of context of the organization is equally applicable to not-for-profit or public service
organizations as it is to those seeking profits.

4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES

This requirement goes beyond what is covered by current clause 7.2,
because it does not include only the direct customers but also the end-
users, suppliers, distributors, retailers and others involved in
the supply chain, regulators and any other relevant interested party.
The intention is also to anticipate current and future needs, EMPLOYEES
because it could lead to the identification of opportunities for
improvement and innovation. The organization is required to monitor
GOVERNMENT
and review the information about these interested parties and their
relevant requirements. COMMUNITY

BUSINESS
4.3 DETERMINING THE SCOPE OF THE QMS STAKEHOLDERS
DESCRIBED IN TERMS OF: INVESTORS
products and services
main processes involved PARTNERS
sites where processes are operated

EXCLUSIONS
CUSTOMERS
This term is not used in ISO 9001:2015. However, the organization
EMPLOYEES
must review the standard requirements and decide which, if not
addressed, would affect their ability to achieve conformity of products
FAMILIES
and services.
4 ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS
TECHNICAL GUIDE
RIBBONS BANNERS
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1 SCOPE
4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES
NEW REQUIREMENT:
2 NORMATIVE REFERENCES
Determination of risks and opportunities
Plan & implement actions to address them
Change to documented information lets the organization
3 TERMS
decide necessity, AND
type and DEFINITIONS
media. But previous terms, such as quality
manual, procedure, record can still be used if the organization RIBBONS BANNERS
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prefers them rutrum mattis mauris nec mollis.

4 CONTEXT OF THE ORGANIZATION

Clause 5 LEADERSHIP

NEW DESCRIPTION
6 PLANNING
5.1 LEADERSHIP FOR THE
AND COMMITMENT
ORIGAMI QMS
BANNERS OF RESPONSABILITIES
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This clause replaces the current clause on management responsibilities.
8 ofOPERATION
The elimination the role of management representative now requires
a more proactive leadership role and greater involvement
IMPORTANT CHANGES:
of top management in identifying risks that can affect the
conformity of products, services, customer satisfaction and integrating Top management to establish, implement and maintain
7 SUPPORT
QMS requirements into its business processes. quality policy
Top-level commitment and empowerment of senior Appropriate
RIBBONStoBANNERS to the purpose and context of the organization
management has been raised up by the new standard, which Available relevant interested parties, as appropriate
means that the responsibility will not RIBBONSlie on one BANNERS person. The quality
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Commitment
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to improve the QMS
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9 PERFORMANCE EVALUATION
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policy must include a commitment to improve rutrum mattisallmaurisrelevant
nec mollis. aspects of the Communicated, understood and applied within the
QMS, not just its effectiveness, and it must provide a framework organization
(that is, a process) for setting the quality objectives. Maintained as documented information
10 IMPROVEMENT

TOP MANAGEMENT
INVOLVED IN:

clarification of mission and

vision
consideration of changes
and trends
relationships, perceptions and
values of stakeholders
strategic priorities and
availability of appropriate
resources
 ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS 5
TECHNICAL GUIDE
5 LEADERSHIP
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COULD INCLUDE ORIGAMI BANNERS
AVOIDANCE, MITIGATION,
Clause 6 PLANNING FOR THE QMS ELIMINATION OR
ACCEPTANCE

8 OPERATION
6.1 ACTIONS TO ADDRESS RISKS
1 SCOPE
AND OPPORTUNITIES

2 SUPPORT
The clause 7on Planning is much broader than the current one. In clause
6.1 the emphasisNORMATIVE REFERENCES
is on the planning of actions to address
risks identified as per clauses 4.1 and 4.2 . In a note, it is suggested
that the options to address these risks may include avoidance of risk,
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3 inPERFORMANCE EVALUATION
9
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taking the risk order to pursue an opportunity, eliminating the source
TERMS AND DEFINITIONS RIBBONS BANNERS
of risk, changing the likelihood or consequences of risk or acceptance
of risk by informed decision. Reference to preventive actions is
now removed from the standard.
10 IMPROVEMENT
4 CONTEXT OF THE ORGANIZATION

6.3 PLANNING OF CHANGES

5 LEADERSHIP
Undertake changes in a planned and systematic manner
by considering:

PLANNING
Potential6consequences FOR THE QMS
of change
Integrity of the QMS
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Availability of resources RIBBONS BANNERS
Allocation or reallocation of responsibilities and authorities
8 OPERATION

Clause 7 SUPPORT

7.1.1 GENERAL Management of all resources is covered under the Support clause.
9 PERFORMANCE EVALUATION It extends what is covered by the current clause with the same title
7.1.2 PEOPLE by adding outsourced products and services, monitoring
7.1.3 INFRASTRUCTURE and measuring equipment and, very important, people and
10 IMPROVEMENT organizational knowledge as a resource. The organization
7.1.4 ENVIRONMENT FOR THE shall provide the necessary manpower for the effective operation of
OPERATION OF PROCESSES the QMS and its processes. When addressing changing needs and
7.1.5 MONITORING AND MEASURING trends it shall consider current knowledge and how to acquire or
access additional necessary knowledge.
RESOURCES It also makes clear that considerations of work environment is limited
7.1.6 ORGANIZATIONAL KNOWLEDGE to the operations of processes.

7.2 COMPETENCE
This clause limits competence to those doing work that
affects its quality performance. Competence is achieved by
appropriate education, training OR experience. There is no
mention of skills as in the current standard. A note suggests different
ways to acquire the necessary competence through provision of
training, mentoring, re-assignment of currently employed people or
hiring or contracting of competent people.

7.4 COMMUNICATION
ORGANIZATION NEEDS TO DETERMINE:

Internal and external communication needs

On what it will communicate
When to communicate
With whom to communicate
How to communicate
 5 LEADERSHIP
6
TECHNICAL GUIDE 2 NORMATIVE REFERENCES
ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS

6 PLANNING FOR THE QMS

3 TERMS AND DEFINITIONS
EMPHASIS ON
ORIGAMI BANNERS PLANNING
Clause 8 OPERATION
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TRACKING & TRACING
4 CONTEXT OF THE ORGANIZATION

7 SUPPORT
8.1 RELEASE OF PRODUCTS AND SERVICES EXPORTING
5 LEADERSHIP
Implement planned activities at appropriate stages to verify that
RIBBONS BANNERS
product and PERFORMANCE
9 services requirements haveEVALUATION
RIBBONS BANNERS beenLoremmet
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rutrum mattis mauris nec mollis.

DeliveryLoremshall not
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consectetur
PLANNING FOR
until the planned
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THE QMS
arrangements verify
conformity, unless otherwise approved by a relevant
authority10 and, IMPROVEMENT where applicable, by the customer
Documented OPERATION
8 information shall provide traceability to the BUSINESS RULES & STANDARDS
people authorizing release of products and services for
delivery to the customer
TRACKING & TRACING
7 SUPPORT

Clause 9 PERFORMANCE EVALUATION

RIBBONS BANNERS
9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION
10 IMPROVEMENT Lorem ipsum dolor sit amet, consectetur adipiscing elit. Integer
rutrum mattis mauris nec mollis.

9.1.1 GENERAL
Determine what to monitor and measure
Determine methods for monitoring, measurement, analysis and
evaluation
Evaluate the quality performance and effectiveness of the
QMS

This new clause covers all monitoring, measurement, analysis

and evaluation activities required by the QMS, RIBBONS describing BANNERS the
requirements in more detail. Monitoring of the customers
Lorem ipsum dolor sit perceptions
amet, consectetur adipiscing elit. Integer
rutrum mattis mauris nec mollis.
of the degree to which requirements have been met, now must include
customer views and opinions of the organization and its
products and services. The use of the output of analysis and evaluation
is listed in detail and includes input to management reviews.

9.2 INTERNAL AUDIT 9.3 MANAGEMENT REVIEW

NEW
The audit program must take into account quality objectives, PlannedORIGAMI
and carried BANNERS out, taking into REQUIREMENTS
customer feedback and changes impacting the changing
account the rutrum mattis mauris nec mollis. business
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organization, in addition to the importance of the processes and

environment and the strategic
the results of previous audits. Documented information must be retained
as evidence of implementation of the audit programs and audit results, direction of the organization.
but there is no requirement for a documented procedure. A note refers
Consider information on the quality
to ISO 19011 for guidance.
performance, including trends and indicators for:
- Non-conformities and corrective actions
- Monitoring and measurement results
RIBBONS BANNERS
RIBBONS
- Audit Lorem
results
BANNERS Lorem ipsum dolor sit amet, consectetur adipiscing elit. Integer
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- Customer satisfaction
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- Issues concerning external providers & interested

parties
- Adequacy of resources
- Process performance and conformity of products & services

Effectiveness of actions to address risks &

opportunities

New potential opportunities for continual improvement

 ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS 7
TECHNICAL GUIDE

WHAT IMPACT TO EXPECT

ON YOUR MANAGEMENT SYSTEM?
Maturity of the
Management system

CHANGES ARE MORE SIGNIFICANT THAN

FOR THE PREVIOUS REVISION
More advanced THE IMPACT OF THE CHANGES DEPENDS ON:
Management LOW MEDIUM The Management System current maturity
System IMPACT IMPACT The organization strategic decision to integrate
more the different Management Systems

More simple
MEDIUM HIGH
Management
System IMPACT IMPACT Towards more integration
of Management systems
Keep the same level of integration Increase integration of
of the Management system the Management systems

WHAT IS THE TRANSITION PROCESS?

GET THE NEW CERTIFICATION ISO: 2015

THE TRANSITION
PROCESS TAKES
INTEGRATE PARTS OF OTHER 6 TO 18 MONTHS
MANAGEMENT SYSTEMS &
UPDATE DOCUMENTATION

MONITOR THE NEW

PROCESSES, PRODUCE
& ANALYSE NEW KPIs.
ACT ACCORDINGLY

TRAIN YOUR CORE TEAM ADAPT YOUR MANAGEMENT

(QUALITY MANAGERS, PROCESSES TO MAKE
INTERNAL AUDITORS, CEO) THEM COMPLIANT

STARTING DATE DEAD-LINE TO MOVE TO

TO PREPARE TRANSITION ISO 2015 CERTIFICATE

2ND QUARTER 2015 3RD QUARTER 2018

During the 3-year-transition period, the organization decides when it transitions.
An organization can still be recertified to the old standard during this period.
Current certificates remain valid until the end of the transition period.
8 ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS
TECHNICAL GUIDE

WHAT ARE YOUR BENEFITS

OF THE TRANSITION?
Less directive
requirements

The creation of
a knowledge-database Quality Management
will ensure the effective is placed at the
internal exchange of very core of business
company-owned governance
You will ensure knowledge
long-lasting customer You will establish
Less emphasis sustainable relationships
satisfaction due on documents
to improved with all relevant
risk-management stakeholders
It will be easier
Limiting the risks for you to meet
involved in the the mandatory
operation of relevant requirements from
processes your customers
HLS makes it
easier for you to Simplified Fewer
integrate more than language prescribed
one standard in and text requirements
your management
The QMS will be
system Better and timely closely aligned with
decisions based the Core Business
on relevant and Processes to
pertinent information facilitate an effective
You have more
implementation It allows all types
freedom to develop
of businesses and
your own way
activity sectors to
to address the
better benefit from
requirements
ISO 9001
of the standard Increasing ability QMS will be
to meet customer and closely taillored
other relevant interested to each organization
parties requirements Anticipation specificities
Higher efficiency of future and current
of the QMS due needs from your You will assure
to higher involvement stakeholders will lead to deliver high quality
of your employees to an early identification products and
and stakeholders of business services
opportunities Greater
Continual motivated
improvement employees

Clients confidence Responsibility

in your products for quality issues
and services will be will be shared between
strengthened several employees
 ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS 9
TECHNICAL GUIDE

HOW CAN BUREAU VERITAS SUPPORT

YOU IN YOUR TRANSITION?

E-LEARNING
COURSES
NOW AVAILABLE!
Get trained to the transition
at your own pace and without
engaging in travel expenses.

AVAILA
BLE
IN DIFF
ERENT
LANGU
AGES

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

BUSINESS CHALLENGE
In a world of ever changing economic, technological and environmental
challenges, companies need to constantly transform themselves to stay
ahead. The international standard for Quality management, ISO 9001
is being revised in 2015 to help drive this competitive advantage.

You want to manage your company transition to ISO

9001:2015 in a fully secure manner andwant to
know what areas of your quality management system
have to be adapted to ISO 9001:2015?

SOLUTION
What is ISO 9001:2015 GAP ANALYSIS TOOL AND
GAP ANALYSIS ON SITE ?
With the gap analysis tool you can review your current quality
management system against the requirements of ISO 9001:2015.
With the Verification on Site, a qualified Bureau Veritas auditor will then
verify and validate the gaps you have identified in your current QMS.
What are the key benefits?
It helps to identify the gap between your current situation and the future
state you want to reach to be compliant to ISO9001:2015.
10 ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS
TECHNICAL GUIDE

AUDIT OF TRANSITION DURING PLANNED AUDITS

WHAT IS IT? Beware: from End of Sept2018, your certificate will no longer be
valid.
The transition requirements are audited as part of one of the
ensuing planned audits such as the surveillance or Recertification WHAT ARE THE BENEFITS FOR YOUR COMPANY?
audit
There is no need of a separate audit.
During this audit, conformance with the revised standard is
assessed along with other requirements Beware: If the organization is found not conform to all the
requirements, non conformities will be raised requiring for closure
WHEN TO DO IT: before a new certificate can be issued.
Whenever you are ready with implementation of all changes
Whenever you are planning for your next surveillance or
Recertification whichever is due at that time

REQUEST A PRE-AUDIT

WHAT IS IT ABOUT? WHAT VALUE DOES IT BRING TO YOUR TRANSITION:

An optional overview and validation audit of ISO 9001:2015
requirements against their current compliance in an ISO 9001:2008
quality management system and the new changes coming from the
revision of the standard.
An opportunity to fully understand the new requirements and their
impact on your existing management system. This can then clarify the
actions you need to take to achieve transition successfully.
BUT:
A pre-audit is completely independent from the transition audit. It
does not grant 9001:2015 or 14001:2015 certification
 ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS 11
TECHNICAL GUIDE

A WIDE RANGE OF
SPECIALIZED TRAINING

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
AWARNESS changes and how these will affect
your organization so you can start
SEMINARS AND putting transition arrangements in
WORKSHOPS place.

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.
INTERNAL
A series of deep dive workshops, which focus on auditing risk, leadership, external provision and
AUDITOR facilitated action are also available for you to attend.
TRAINING

This course will enable you to

identify the core changes and
requirements of ISO. It will assist
you with the implementation of
the changes within your business.
On completion of the course, you will
REVISED 2015 be able to apply your knowledge
of the amended requirements to
STANDARDS ISO 9001:2015 to develop
TRAINING an action plan to aid your
implementation processes.

This workshop will help you identify the requirements of ISO 9001:2015 with regard to process risk
management and identify the tools and techniques to implement a risk based approach within your
management system.

RISK On completion of the course, you will be able to apply your knowledge to identify, classify, quantify
and treat risks and develop an action plan to implement a risk your organizations.
MANAGEMENT
TRAINING

TO FIND OUT MORE ABOUT TRAINING AVAILABILITY AND TIMES,

PLEASE CONTACT YOUR LOCAL BUREAU VERITAS PARTNER
 HOW TO GET MORE INFORMATION ?

STAY UP-TO-DATE
THANKS TO OUR WEBSITE
REVISION2015.COM!

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