ISO 9001-2015, Los Puntos Relevantes de La Nueva Versión 2015

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ISO 9001:2015 : An Overview of Changes 260, Rue Sherbrooke Est, bureau 124
2750, Rue Einstein, bureau 350
INLAC Québec (Québec) Canada G1P 4R1 Montréal (Québec) Canada H2X 1E1
Martes 26 de Mayo 2015 Tel : (418) 650-0675 Tel : (514) 286-9693
1
email : plesperance@qualiso.com
An Overview of the Major Changes in ISO
9001:2015 and Ideas to Consider in the
Implementation of the Requirements
Presented by Pierre L’Espérance, P.Eng., MBA

Senior Partner, Le Groupe Qualiso
Canadian Delegate Expert ISO TC 176 SC2 WG24
LE GROUPE 2750, Rue Einstein, bureau 350 260, Rue Sherbrooke Est, bureau 124
Québec (Québec) Canada G1P 4R1 Montréal (Québec) Canada H2X 1E1
Tel : (418) 650-0675 Tel : (514) 286-9693
email : plesperance@qualiso.com
ISO 9001:2015 : An Overview of Changes Inlac – Martes 26 de Mayo 2015 2

Why Review ISO 9001?
• Prescribed periodic revision
• ISO Directives: “High Level Structure” common
for all system management standards (Annex SL)
• Consideration to satisfy SME’s needs
• Consideration to satisfy Service Organization’s
needs
• Update of Quality Management Principles
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ISO 9001:2015 : Inlac – Martes 26 de Mayo 2015 3
An Overview of Changes
ISO 9001:2008
Quality Management System
Extract ISO 9001:2008

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ISO 9001:2015 Revision Inputs
• ISO/IEC Directives, Part 2 Rules for the structure
and drafting of International Standards
• ISO/IEC Directives, Part 1 — Consolidated ISO
Supplement — Procedures specific to ISO
• Process approach, which incorporates the Plan-Do-
Check-Act (PDCA) cycle and risk-based thinking
• Update of Quality Management Principles
• Worldwide survey and validation
• ISO 9000 Quality management systems —
Fundamentals and vocabulary
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Quality Management Principles
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship management
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A Change of Organizational Culture
Organizational
culture gap
Leadership
Continuous improvement
Customer satisfaction
ISO 9004:2009
Organization Business
Excellence
ISO Models
P D 9001:2015
Quality A C ISO
Tools
9001:2000
ISO
9001:1987
Conformity Customer Consideration Performance
satisfaction of risks improvement
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ISO 9001:2015
Quality Management System
Extract ISO FDIS 9001:2015

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4. Context of the Organization
What’s new?:
• Understanding the organization and its context
• Understanding the needs and expectations of
interested parties
• Determining the scope of the quality management
system
Challenge:
• Comprehension of the requirement
• How to audit this requirement (the registrar!)
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Case Example : Target
How did we miss the target?
• Find better, pay less. At least this is what
Target advertised when the opened their
stores across Canada, innovating products at
a lesser cost.
• Target opened its first Canadian stores in
March 2013. 15 January 2015, the journey
ends and Target announces it will close its
133 banner store across the country. 18000
job losses
• Empty shelves during launching, perception of higher prices than
the competition did not please clients.
• The creation of the habit of frequentation never materialized with
its clients.
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Lessons learned
• Communication and managerial
engagement: For the Team members on
the retail side, Target’s corporate head
office was a distant and disinterested
overseer.
• Lack of adaptability: Target always taught
its team members to be “Resilient and
Adaptable”, but it seemed that higher
management did not take the same
advice
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Lessons learned
• “Too much too fast.” The extremely
high burn rate: Target invested nearly
$2 billion into its initial Canadian
expansion, building new stores and
taking over leases for Zellers locations
across the country.
• Aiming for growth, forgetting to scale:
By jumping aggressively into the
Canadian market, Target apparently
ignored the lessons it could have
learned from its biggest competitor,
Walmart.
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5. Leadership
What’s new?:
• Promoting the use of the process approach and
risk-based thinking
• Top management shall demonstrate leadership with
respect to customer focus by ensuring that the risks
and opportunities that can affect conformity of
products and services and the ability to enhance
customer satisfaction are determined and
addressed.
• Policy with commitment to satisfy applicable
requirements and to continual improvement of the
quality management system.
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5. Leadership
Challenge:
• Evidence of leadership with tangible actions from
top management.
• More emphasis on the meeting customer
requirements.
• Top management is the driving force
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Case Example : PUR Vodka
A Tale of pure perseverance
• Year 2006, Nicolas Duvernois,
bachelor in Political Science, knows
nothing about Vodka, opened a
restaurant and failed miserably,
however learned that Vodka is a
very popular product.
• 2007, 25 year old, shaved head, several tattoos, no banker is

interested in his project. From 2007 to 2009, he cleans hospital
floors at night shift to finance his project.
• 2009, 10 800 first bottles on stock, our monopolistic government
owned liquor store (SAQ) refuses to distribute the first Québec
owned producer.
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Finally, … The reward
• Year 2009, not a single bottle sold yet, PUR
Vodka wins the World Vodka Masters in
London, The biggest competition in the
world. That night after hanging up the
phone, he went working at the hospital. The
next day, a New Zeeland distributer placed an
order.
• And PUR Vodka will win again in 2011 and
2014. Today, PUR Vodka has won more than
33 prizes around the world, is considered one
of the best vodka and is now sold in the SAQ
and hundreds of restaurants in Québec.
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Finally, … The reward
• 2015, estimated 250 000 bottles to be sold this year in Canada.
Next month, PUR Vodka will lauch a more agressive strategy in
the rest of Canada.
• “I knew nothing about vodka, but I knew that the better the
water, the better the vodka,” he said in an interview. “In Quebec
we’re supposed to have the world’s best water, so how come no
one makes vodka?”
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6. Planning
What’s new?:
• Actions to address risks and opportunities
• When planning for the quality management system,
the organization shall consider the issues referred
in the context and determine the risks and
opportunities that need to be addressed to
• give assurance that the quality management system can
achieve its intended result(s);
• enhance desirable effects;
• prevent, or reduce, undesired effects;
• achieve improvement.
• The organization shall plan actions to address these
risks and opportunities
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6. Planning
What’s new?:
• Quality objectives and planning to achieve them
• what will be done;
• what resources will be required;
• who will be responsible;
• when it will be completed;
• how the results will be evaluated.
• Planning of changes
• the purpose of the changes and their potential
consequences;
• the integrity of the quality management system;
• the availability of resources;
• the allocation or reallocation of responsibilities and
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authorities.
6. Planning
Challenge:
• Actions taken to address risks and opportunities
shall be proportionate to the potential impact on
the conformity of products and services
• Better links between improvement and objectives.
• Clearly identify what is a change and when will the
organization act upon a change.
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Case Example : Bombardier Aerospace
The good, the bad and the ugly
• The good, Bombardier expects the
CSeries to burn 20% less fuel per
trip than these competitors.
Bombardier’s third largest Cseries
customer, Moscow-based lessor
Ilyushin Finance Corporation (IFC),
says, the performance of the
CS100 flight test aircraft is “quite
spectacular”. With the exception of
a small weight increase, the CS100
is meeting Bombardier’s promises
for fuel efficiency and range.
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• The bad, IFC is concerned Bombardier will announce another
schedule delay. The CS100 was originally expected to enter
service in late 2013. It is now scheduled to be certificated in the
second half of 2015. It was also supposed to enter service by the
end of the year, but newly-appointed Bombardier chief
executive Alain Bellemare has recently said that entry into
service could slip into 2016.
• The ugly, IFC has grown impatient waiting for the CSeries to be
delivered. IFC now plans to decide whether to cancel, amend or
proceed with the CSeries order at the Paris air show, which
begins on 15 June.
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• The cost of program so
far, US$ 5.4 billion as of
February 2015.
Bombardier is still
facing repeated delays
and a new financing
problem.
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7. Support
What’s new?:
• Organizational knowledge
• The organization shall determine the knowledge
necessary for the operation of its processes and to
achieve conformity of products and services.
• This knowledge shall be maintained and be made
available to the extent necessary.
• When addressing changing needs and trends, the
organization shall consider its current knowledge and
determine how to acquire or access any necessary
additional knowledge and required updates.
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7. Support
What’s new?:
• Documented information
• Creating and updating
• Control of documented information
• Communication
• on what it will communicate;
• when to communicate;
• with whom to communicate;
• how to communicate;
• who communicates.
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7. Support
Challenge:
• Change the way you think about documentation
• Identify what are the expertise the organization
must absolutely retain
• Communicate, yes, but effectively!!!
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Case Example : Biscuits Leclerc and Poka
Welcome social media
• Alexandre Leclerc, son of executive
from Biscuits Leclerc, while doing
graduate studies in 2011 at the Hult
International Business School in San
Francisco had the inspiration from a
Pennsylvania plant, where several
employees left for the shale gas
boom
• One PowerPoint presentation to his
father and friend Antoine Bisson
(then with Microsoft) and 2.5
$million capital risk financing
generated the Poka start-up.
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• Poka is the first social industrial
platform that focuses towards
efficient training, knowledge
retention and real-time
information within the
manufacturing world.
• Since 2013, more than 4000
videos viewed by employees. The
co-founders of Poka estimate
Biscuit Leclerc will be better
prepared to face baby-boomer
retirement.
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8 Operation
What’s new?:
• Control of externally provided processes, products
and services
• The organization shall determine and apply criteria for
the evaluation, selection, monitoring of performance,
and re-evaluation of external providers, based on their
ability to provide processes or products and services in
accordance with requirements. The organization shall
retain documented information of these activities and
any necessary actions arising from the evaluations.
• Type and extent of control
• Information for external providers
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8 Operation
What’s new?:
• Control of changes
• The organization shall review and control changes for
production or service provision, to the extent necessary
to ensure continuing conformity with requirements.
• Still the same emphasis on
• Operational planning and control
• Determination of requirements for products and services
• Design and development of products and services
• Production and service provision
• Control of nonconforming outputs
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8 Operation
Challenge:
• Be coherent with the risks identified within your
organization
• Control your activities in relation with the context
of your organization
• Identify your critical external provides
• Control changes
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Case Example : Cirque du Soleil
The art of perfection
• Cirque du Soleil is a Quebec based company recognized all
over the world for high-quality, artistic entertainment.
• Cirque du Soleil at a glace:
• In 1984, 73 people worked for Cirque du Soleil. Today, the
business has 4,000 employees worldwide, including more
than 1,300 artists.
• At the Montreal International Headquarters alone, there
are close to 1,500 employees.
• More than 100 types of occupations can be found at
Cirque.
• The company’s employees and artists represent more than
50 nationalities and speak 25 different languages.
• Close to 150 million spectators have seen a Cirque du
Soleil show since 1984.
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• April 2015, Cirque du Soleil founder Guy
Laliberté sold 80 per cent of his stock in the
Cirque to a consortium that
includes American private equity firm, TPG
Capital Inc., and a Chinese conglomerate,
Fosun Capital Group. Quebec’s pension fund
manager, the Caisse de dépôt et de
placement, took a 10-per-cent stake in the
company, while Laliberté kept 10 per cent of
his shares.
• The deal values the Cirque du Soleil at $2
billion, according to various reports.
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9. Performance evaluation
What’s new?:
• Analysis and evaluation
• The organization shall determine:
• what needs to be monitored and measured;
• the methods for monitoring, measurement, analysis and
evaluation needed to ensure valid results;
• when the monitoring and measuring shall be performed;
• when the results from monitoring and measurement
shall be analysed and evaluated.
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What’s new?:
• Analysis and evaluation
• The results of analysis shall be used to evaluate:
• conformity of products and services;
• the degree of customer satisfaction;
• the performance and effectiveness of the quality
management system;
• if planning has been implemented effectively;
• the effectiveness of actions taken to address risks and
opportunities;
• the performance of external providers;
• the need for improvements to the quality management
system.
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Challenge:
• There are so many methods of measurements
• There are many types of data within the
organization
• How do all these measures help the organization
take the best decisions?
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Case Example : Crocs
Love them, hate them
• In June 2004, Crocs
purchased Québec
City Based Foam
Creations and their
manufacturing
operations to secure
exclusive rights to
the proprietary
foam resin called
Croslite.
• April 2008, the closing of the only Canadian plant of Crocs,
which is also the birthplace of the colourful footwear, was
denounced in medias as a "pure case of savage capitalism" by
the Quebec government. 600 jobs were lost in Québec City.
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Case Example :
Crocs
Love them,
hate them
• By 2007, Crocs
was a national
phenomenon.
Annual sales surged
to $847 million, up a
staggering 137
percent from the
previous year, and
shares shot past
$70. And nobody
really knew why. Bloomberg Business, 1 April 2015
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10. Improvement
What’s new?:
• The organization shall determine and select
opportunities for improvement and implement any
necessary actions to meet customer requirements
and enhance customer satisfaction.
• The organization shall consider the results of
analysis and evaluation, and the outputs from
management review, to determine if there are
needs or opportunities that shall be addressed as
part of continual improvement.
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10. Improvement
Challenge:
• Make sure to link improvement with customer
satisfaction and organization’s objectives.
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Case Example : Chocolats Favoris
Taste it … addicted!
• 2000, Dominique Brown, age 22 founded Beenox, a
video game developer, now wholly owned subsidiary
of Activision since 2005 (Call of Duty, Crash Bandicoot,
Guitar Hero, Spiderman).
• 2012, Dominique Brown, 34, quits Beenox and
acquires Chocolats favoris. He cracked for the taste and
reputation.
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• Chocolats Favoris
has invested in R&D
to develop a new
product that is sold
in a grocery store.
The chocolate
fondue in a can that
has nothing with the
taste of a can.
• Summer, ice cream,
cold winters, the
simplicity of the can.
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• Chocolats Favoris has an
overwhelming success and
will invest $3.6 million to
reunite all its production
activities in one central
location. This will increase its
capacity and respond to
growing demand of its
products.
• The facility has been designed
to prepare for all food safety
certification and will be ready
for export and conquest of
other markets.
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An Overview of the Major Changes in ISO
9001:2015 and Ideas to Consider in the
Implementation of the Requirements
Muchas Gracias
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LE GROUPE

Strategy Consulting Improvement

Productivity Communication Teamwork

Presented by Pierre L’Espérance, P.Eng., MBA

ISO 9001:2015 : An Overview of Changes Inlac – Martes 26 de Mayo 2015 2

Extract ISO 9001:2008

Extract ISO FDIS 9001:2015

• 2007, 25 year old, shaved head, several tattoos, no banker is

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