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the transition
successfully
ISO 9001:2015
TOP MANAGEMENT - QUALITY MANAGERS
TECHNICAL GUIDE
PLAN
4
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
Production
& service
provision
Introductory
clauses
Basic clauses,
common to all
management
systems standards
Clause 2
NORMATIVE REFERENCES
Clause 3
Clause 4
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
Internal audit
Management
review
Continuous
inprovement
Control of
externally
proc.prod. &
services
Clause 1 SCOPE
10
Release of
products
& services
Non conforming
processes
prod.
& services
Clause 4
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
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.
EMPLOYEES
GOVERNMENT
COMMUNITY
BUSINESS
STAKEHOLDERS
INVESTORS
PARTNERS
EMPLOYEES
FAMILIES
CUSTOMERS
RIBBONS BANNERS
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SCOPE
NORMATIVE REFERENCES
Clause 5
RIBBONS BANNERS
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6 PLANNING
FOR THE
QMS
5.1 LEADERSHIP
AND COMMITMENT
ORIGAMI
BANNERS
NEW DESCRIPTION
OF RESPONSABILITIES
10 IMPROVEMENT
IMPORTANT CHANGES:
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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Commitment
to improve the QMS
Communicated, understood and applied within the
organization
Maintained as documented information
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
COULD INCLUDE
AVOIDANCE, MITIGATION,
ELIMINATION OR
ACCEPTANCE
ORIGAMI BANNERS
Clause 6
LEADERSHIP
8 OPERATION
6.1 ACTIONS
TO ADDRESS RISKS
1 SCOPE
AND OPPORTUNITIES
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.
RIBBONS BANNERS
10 IMPROVEMENT
4 CONTEXT OF THE ORGANIZATION
LEADERSHIP
Clause
OPERATION
SUPPORT
RIBBONS BANNERS
Potential6consequences
of change
PLANNING
FOR THE QMS
Integrity of the QMS
Availability of resources
Allocation or reallocation of responsibilities and authorities
7.1.1
GENERAL
9 PERFORMANCE
EVALUATION
7.1.2 PEOPLE
7.1.3 INFRASTRUCTURE
10 IMPROVEMENT
7.1.4
ENVIRONMENT FOR THE
OPERATION OF PROCESSES
7.1.5 MONITORING AND MEASURING
RESOURCES
7.1.6 ORGANIZATIONAL KNOWLEDGE
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:
5
6
LEADERSHIP
2 NORMATIVE REFERENCES
Clause
ORIGAMI BANNERS
8
PLANNING
OPERATION
4 CONTEXT OF THE ORGANIZATION
7 SUPPORT
8.1 RELEASE
OF PRODUCTS AND SERVICES
5
EXPORTING
LEADERSHIP
RIBBONS BANNERS
Documented
shall provide traceability to the
8 information
OPERATION
people authorizing release of products and services for
delivery to the customer
Clause
SUPPORT
PERFORMANCE EVALUATION
9.1 MONITORING,
MEASUREMENT, ANALYSIS AND EVALUATION
10 IMPROVEMENT
RIBBONS BANNERS
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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
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requirements in more detail. Monitoring of the customers
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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.
PlannedORIGAMI
and carried
out, taking into
BANNERS
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account
the rutrum
changing
mattis mauris nec mollis. business
environment and the strategic
direction of the organization.
NEW
REQUIREMENTS
More advanced
Management
System
More simple
Management
System
LOW
IMPACT
MEDIUM
IMPACT
MEDIUM
IMPACT
HIGH
IMPACT
THE TRANSITION
PROCESS TAKES
6 TO 18 MONTHS
STARTING DATE
TO PREPARE TRANSITION
DEAD-LINE TO MOVE TO
ISO 2015 CERTIFICATE
HLS makes it
easier for you to
integrate more than
one standard in
your management
system
The creation of
a knowledge-database
will ensure the effective
internal exchange of
company-owned
knowledge
Quality Management
is placed at the
very core of business
governance
Less emphasis
on documents
It will be easier
for you to meet
the mandatory
requirements from
your customers
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
Fewer
prescribed
requirements
Simplified
language
and text
Better and timely
decisions based
on relevant and
pertinent information
Responsibility
for quality issues
will be shared between
several employees
QMS will be
closely taillored
to each organization
specificities
You will assure
to deliver high quality
products and
services
Greater
motivated
employees
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
10
REQUEST A PRE-AUDIT
WHAT IS IT ABOUT?
A WIDE RANGE OF
SPECIALIZED TRAINING
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
AUDITOR
TRAINING
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
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.
11
STAY UP-TO-DATE
THANKS TO OUR WEBSITE
REVISION2015.COM!
How to manage
the transition
successfully
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ISO 14001:2015
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TECHNICAL GUIDE
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