ISO9001-2015 Technical+Guide

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

TECHNICAL GUIDE

TECHNICAL GUIDE
WHAT ARE THE MAIN CHANGES

IN ISO 9001?
DO
PLAN
4
A WIDE RANGE OF
SPECIALIZED TRAINING
CHECK
ACT
CONTEXT
OF THE
ORGANIZATION
Understanding
the
organization
and its context
Needs &
expectations
of interested
parties
Scope
of the QMS
OPERATION
LEADERSHIP
PLANNING
PERFORMANCE
EVALUATION
SUPPORT
Actions
to address
risks and
opportunities
Leadership
and
commitment
Quality policy
Roles,
responsibilities
& authorities
Quality
objectives
& planning
Planning of
changes
Resources
Operational
planning
& control
Competence
Awareness
Determination
of requirements
for prod.
& services
Communication
Documented
information
QMS & its

processes
Production
& service
provision
Introductory
clauses
Basic clauses,
common to all
management
systems standards
Clause 2
NORMATIVE REFERENCES
Clause 3
TERMS AND DEFINITIONS
Clause 4
CONTEXT OF THE ORGANIZATION
Clause 5
LEADERSHIP
Clause 6
PLANNING
Clause 7
SUPPORT
Clause 8
OPERATION
Clause 9
PERFORMANCE EVALUATION
Clause 10 IMPROVEMENT
Monitoring,
measurement
analysis
& eval.
IMPROVEMENT
Non conformity
& corrective
actions
AWARNESS
SEMINARS AND
WORKSHOPS
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.
Internal audit
Management
review
Continuous
inprovement
Design & devel.

of products
& services
Control of
externally
proc.prod. &
services
Clause 1 SCOPE
10
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 organization so you can start
putting transition arrangements in
place.
INTERNAL
AUDITOR
TRAINING
The new model is similar to the previous

one. Although the intention is not to
recommend the sequence of
activities that an organization follows
in the implementation of a management
system, each organization is free
to interpret the model as it
sees fit.
Release of
products
& services
A series of deep dive workshops, which focus on auditing risk, leadership, external provision and
facilitated action are also available for you to attend.
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.
REVISED 2015
STANDARDS
TRAINING
Non conforming
processes
prod.
& services
The high-level structure proposed in Annex SL for all ISO

management systems includes, in addition to the usual 3
introductory clauses, 7 basic clauses common
to all management system standards. They are:
context of the organization, leadership, planning, support,
operation, performance evaluation and improvement. For
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
with organizational planning and process management.
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.
On completion of the course, you will

be able to apply your knowledge
of the amended requirements to
ISO 9001:2015 to develop
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
MANAGEMENT
TRAINING
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.
TO FIND OUT MORE ABOUT TRAINING AVAILABILITY AND TIMES,

PLEASE CONTACT YOUR LOCAL BUREAU VERITAS PARTNER
11
10

TECHNICAL GUIDE
AUDIT OF TRANSITION DURING PLANNED AUDITS

WHAT IS IT?
The transition requirements are audited as part of one of the
ensuing planned audits such as the surveillance or Recertification
audit
During this audit, conformance with the revised standard is
assessed along with other requirements
WHEN TO DO IT:
Clause 4

TECHNICAL GUIDE
TERMS AND DEFINITIONS

Beware: from End of Sept2018, your certificate will no longer be

valid.
WHAT ARE THE BENEFITS FOR YOUR COMPANY?
There is no need of a separate audit.
Beware: If the organization is found not conform to all the
requirements, non conformities will be raised requiring for closure
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
5 LEADERSHIP
4.1 UNDERSTANDING
THE ORGANIZATION AND ITS CONTEXT
Annex SL has introduced two new clauses related to the context
of the organization:
Both clauses
the organization to
6 PLANNING
FOR require
THE QMS
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
system. Although reference is made to the determination of requirements
of relevant 8
stakeholders,
there are no additional requirements to ensure
OPERATION
that goods and services meet the needs and expectations of external
entities other than those already identified in ISO 9001:2008. The
organizations top management must be involved directly and actively
7 SUPPORT
in the clarification
of its mission and vision, considering both the internal
and external issues that may affect its ability to achieve the desired
results. The requirements include the consideration of changes
and trends,
relationships, perceptions and values of
9 PERFORMANCE
EVALUATION
stakeholders, strategic priorities, the availability of
10 IMPROVEMENT
resources, and other issues which could have an impact on the

objectives of the organization.
The context of the organization refers to the business
environment it is operating in. To do this, it must first decide what
are the intended results of its QMS and then determine the
relevant internal and external issues that affect its ability to
achieve those results.
Understanding the external context can be facilitated by considering
issues arising from legal, technological, competitive,
market, cultural, social, and economic environments, whether
international, national, regional or local. Understanding the internal
context can be facilitated by considering issues related to values,
culture, knowledge and performance of the organization.
BUSINESS ENVIRONMENT
EXTERNAL ISSUES
INTERNAL ISSUES
TECHNOLOGICAL
ECONOMIC
MARKET
COMPETITIVE
CULTURE
KNOWLEDGE
INTENDED
R E S U LT S
VALUES
PERFORMANCE
CULTURAL
LEGAL
SOCIAL
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.
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
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 endusers, 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,
because it could lead to the identification of opportunities for
improvement and innovation. The organization is required to monitor
and review the information about these interested parties and their
relevant requirements.
EMPLOYEES
GOVERNMENT
COMMUNITY
BUSINESS
STAKEHOLDERS
4.3 DETERMINING THE SCOPE OF THE QMS

DESCRIBED IN TERMS OF:
products and services
main processes involved
sites where processes are operated
EXCLUSIONS
This term is not used in ISO 9001:2015. However, the organization
must review the standard requirements and decide which, if not
addressed, would affect their ability to achieve conformity of products
and services.
INVESTORS
PARTNERS
EMPLOYEES
FAMILIES
CUSTOMERS

TECHNICAL GUIDE

TECHNICAL GUIDE
RIBBONS BANNERS
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rutrum mattis mauris nec mollis.
SCOPE
4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES

NEW REQUIREMENT:
NORMATIVE REFERENCES
Determination of risks and opportunities

Plan & implement actions to address them
Change to documented information lets the organization
3 TERMS
AND
DEFINITIONS
decide necessity,
type and
media.
But previous terms, such as quality
manual, procedure, record can still be used if the organization
prefers them
Clause 5
HOW CAN BUREAU VERITAS SUPPORT

YOU IN YOUR TRANSITION?
RIBBONS BANNERS
E-LEARNING
COURSES
NOW AVAILABLE!

LEADERSHIP
6 PLANNING
FOR THE
QMS
5.1 LEADERSHIP
AND COMMITMENT
ORIGAMI
BANNERS
Get trained to the transition

at your own pace and without
engaging in travel expenses.
NEW DESCRIPTION
OF RESPONSABILITIES

This clause replaces the current clause on management responsibilities.

The elimination
the role of management representative now requires
8 ofOPERATION
a more proactive leadership role and greater involvement
of top management in identifying risks that can affect the
conformity of products, services, customer satisfaction and integrating
7 SUPPORT
QMS requirements
into its business processes.
Top-level commitment and empowerment of senior
management has been raised up by the new standard, which
RIBBONS
BANNERS
means that the responsibility will not
lie on one
person. The quality
9 PERFORMANCE
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amet, consectetur adipiscing elit. Integer
EVALUATION
policy must include a commitment to improve
aspects of the
rutrum mattisall
maurisrelevant
nec mollis.
QMS, not just its effectiveness, and it must provide a framework
(that is, a process) for setting the quality objectives.
10 IMPROVEMENT
IMPORTANT CHANGES:
AVAILA
BLE
IN DIFF
ERENT
LANGU
AGES
Top management to establish, implement and maintain

quality policy
Appropriate
to the purpose and context of the organization
RIBBONStoBANNERS
Available
relevant
interested parties, as appropriate
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adipiscing elit. Integer
Commitment
to improve the QMS
Communicated, understood and applied within the
organization
Maintained as documented information
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.
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
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.
WHAT ARE YOUR BENEFITS

OF THE TRANSITION?
Clause 6
Less directive
requirements
The QMS will be

closely aligned with
the Core Business
Processes to
facilitate an effective
implementation
Increasing ability
to meet customer and
other relevant interested
parties requirements
Anticipation
of future and current
needs from your
stakeholders will lead
to an early identification
of business
opportunities
Higher efficiency
of the QMS due
to higher involvement
of your employees
and stakeholders
Continual
improvement
Clients confidence
in your products
and services will be
strengthened
Responsibility
for quality issues
will be shared between
several employees
6.3 PLANNING OF CHANGES

5
LEADERSHIP
Potential6consequences
of change
PLANNING
FOR THE QMS
Integrity of the QMS
Availability of resources
Allocation or reallocation of responsibilities and authorities
Clause
You will assure

to deliver high quality
products and
services
OPERATION
SUPPORT
7.1.1
GENERAL
9 PERFORMANCE
EVALUATION
7.1.2 PEOPLE
7.1.3 INFRASTRUCTURE
10 IMPROVEMENT
ENVIRONMENT FOR THE
7.1.4
OPERATION OF PROCESSES
7.1.5 MONITORING AND MEASURING
RESOURCES
7.1.6 ORGANIZATIONAL KNOWLEDGE
It allows all types

of businesses and
activity sectors to
better benefit from
ISO 9001
QMS will be
closely taillored
to each organization
specificities
Greater
motivated
employees
10 IMPROVEMENT
4 CONTEXT OF THE ORGANIZATION
Undertake changes in a planned and systematic manner

by considering:
Fewer
prescribed
requirements
Simplified
language
and text
Better and timely
decisions based
on relevant and
pertinent information
You will establish

sustainable relationships
with all relevant
stakeholders
RIBBONS BANNERS
It will be easier
for you to meet
the mandatory
requirements from
your customers
Limiting the risks

involved in the
operation of relevant
processes
The clause 7
on Planning is much broader than the current one. In clause
2 SUPPORT
NORMATIVE
REFERENCES
6.1 the emphasis
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,
9
EVALUATION
taking the risk
order to pursue an opportunity,
eliminating the source
3 inPERFORMANCE
TERMS
AND DEFINITIONS
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.

You have more

freedom to develop
your own way
to address the
requirements
of the standard
Less emphasis
on documents
8 OPERATION
6.1 ACTIONS
TO ADDRESS RISKS
1 SCOPE
AND OPPORTUNITIES
RIBBONS BANNERS
HLS makes it
easier for you to
integrate more than
one standard in
your management
system
Quality Management
is placed at the
very core of business
governance
PLANNING FOR THE QMS
COULD INCLUDE
AVOIDANCE, MITIGATION,
ELIMINATION OR
ACCEPTANCE

You will ensure

long-lasting customer
satisfaction due
to improved
risk-management
The creation of
a knowledge-database
will ensure the effective
internal exchange of
company-owned
knowledge

TECHNICAL GUIDE
LEADERSHIP
ORIGAMI BANNERS

TECHNICAL GUIDE

Management of all resources is covered under the Support clause.

It extends what is covered by the current clause with the same title
by adding outsourced products and services, monitoring
and measuring equipment and, very important, people and
organizational knowledge as a resource. The organization
shall provide the necessary manpower for the effective operation of
the QMS and its processes. When addressing changing needs and
trends it shall consider current knowledge and how to acquire or
access additional necessary knowledge.
It also makes clear that considerations of work environment is limited
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
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
ways to acquire the necessary competence through provision of

training, mentoring, re-assignment of currently employed people or
hiring or contracting of competent people.
5
6
LEADERSHIP
2 NORMATIVE REFERENCES

TECHNICAL GUIDE
Clause
PLANNING FOR THE QMS

3 TERMS AND DEFINITIONS
EMPHASIS ON
ORIGAMI BANNERS
8

TECHNICAL GUIDE
OPERATION
4 CONTEXT OF THE ORGANIZATION
TRACKING & TRACING
7 SUPPORT
8.1 RELEASE
OF PRODUCTS AND SERVICES
5
WHAT IMPACT TO EXPECT

ON YOUR MANAGEMENT SYSTEM?
PLANNING

Maturity of the
Management system
EXPORTING
LEADERSHIP
Implement planned activities at appropriate stages to verify that

RIBBONS BANNERS
9 services
product and
requirements haveEVALUATION
beenLoremmet
PERFORMANCE
ipsum dolor sit amet, consectetur adipiscing elit. Integer
RIBBONS BANNERS
Delivery shall not6proceed

until the planned
arrangements
verify
PLANNING
FOR
THE QMS
conformity, unless otherwise approved by a relevant
authority
where applicable, by the customer
10 and,
IMPROVEMENT
7
Clause
CHANGES ARE MORE SIGNIFICANT THAN

FOR THE PREVIOUS REVISION
THE IMPACT OF THE CHANGES DEPENDS ON:

Documented
shall provide traceability to the
8 information
OPERATION
people authorizing release of products and services for
delivery to the customer
BUSINESS RULES & STANDARDS
More advanced
Management
System
LOW
IMPACT
MEDIUM
IMPACT
MEDIUM
IMPACT
HIGH
IMPACT
The Management System current maturity

The organization strategic decision to integrate
more the different Management Systems
TRACKING & TRACING
SUPPORT
More simple
Management
System
PERFORMANCE EVALUATION
9.1 MONITORING,
MEASUREMENT, ANALYSIS AND EVALUATION
10 IMPROVEMENT
RIBBONS BANNERS
Keep the same level of integration Increase integration of

of the Management system the Management systems
Towards more integration

of Management systems
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,
describing
the
RIBBONS
BANNERS
Lorem ipsum dolor sit perceptions
amet, consectetur adipiscing elit. Integer
requirements in more detail. Monitoring of the customers
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
The audit program must take into account quality objectives,

customer feedback and changes impacting the
organization, in addition to the importance of the processes and
the results of previous audits. Documented information must be retained
as evidence of implementation of the audit programs and audit results,
but there is no requirement for a documented procedure. A note refers
to ISO 19011 for guidance.
PlannedORIGAMI
and carried
out, taking into
BANNERS
account
the rutrum
changing
mattis mauris nec mollis. business
environment and the strategic
direction of the organization.
WHAT IS THE TRANSITION PROCESS?

GET THE NEW CERTIFICATION ISO: 2015
INTEGRATE PARTS OF OTHER

MANAGEMENT SYSTEMS &
UPDATE DOCUMENTATION
NEW
REQUIREMENTS
Consider information on the quality

performance, including trends and indicators for:
- Non-conformities and corrective actions
RIBBONS BANNERS
- Monitoring and measurement results
RIBBONS
BANNERS
- Audit Lorem
results
ipsum dolor sit amet, consectetur adipiscing elit. Integer
- Customer satisfaction
- 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
THE TRANSITION
PROCESS TAKES
6 TO 18 MONTHS
MONITOR THE NEW

PROCESSES, PRODUCE
& ANALYSE NEW KPIs.
ACT ACCORDINGLY
TRAIN YOUR CORE TEAM

(QUALITY MANAGERS,
INTERNAL AUDITORS, CEO)
STARTING DATE
TO PREPARE TRANSITION
2ND QUARTER 2015
ADAPT YOUR MANAGEMENT

PROCESSES TO MAKE
THEM COMPLIANT
DEAD-LINE TO MOVE TO
ISO 2015 CERTIFICATE
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.

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HOW TO GET MORE INFORMATION ?

LEARN ABOUT THE CHANGES

SHARE YOUR QUESTIONS AND DISCUSS THEM WITH YOUR

Join our community

TOP MANAGEMENT - ENVIRONMENTAL MANAGER

Move Forward with Confidence

Move Forward with Confidence

ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS

ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS

WHAT ARE THE MAIN CHANGES

QMS & its

TERMS AND DEFINITIONS

CONTEXT OF THE ORGANIZATION

Design & devel.

This course will help you find out

The new model is similar to the previous

This course will enable you to

The high-level structure proposed in Annex SL for all ISO

On completion of the course, you will

TO FIND OUT MORE ABOUT TRAINING AVAILABILITY AND TIMES,

ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS

AUDIT OF TRANSITION DURING PLANNED AUDITS

ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS

TERMS AND DEFINITIONS

Beware: from End of Sept2018, your certificate will no longer be

Whenever you are ready with implementation of all changes

resources, and other issues which could have an impact on the

WHAT VALUE DOES IT BRING TO YOUR TRANSITION:

An optional overview and validation audit of ISO 9001:2015

An opportunity to fully understand the new requirements and their

4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES

4.3 DETERMINING THE SCOPE OF THE QMS

ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS

ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS

4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES

Determination of risks and opportunities

HOW CAN BUREAU VERITAS SUPPORT

CONTEXT OF THE ORGANIZATION

Get trained to the transition

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Integer

This clause replaces the current clause on management responsibilities.

Top management to establish, implement and maintain

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

You want to manage your company transition to ISO

WHAT ARE YOUR BENEFITS

The QMS will be

6.3 PLANNING OF CHANGES

You will assure

It allows all types

Undertake changes in a planned and systematic manner

You will establish

Limiting the risks

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Integer

You have more

PLANNING FOR THE QMS

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Integer

You will ensure

ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS

ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Integer

Management of all resources is covered under the Support clause.

Internal and external communication needs

ways to acquire the necessary competence through provision of