LE GROUPE ISO - INLAC€¦ · ISO LE GROUPE ISO 9001:2015 : An Overview of Changes INLAC Martes 26 de Mayo 2015. ... ISO 9001:2015 Revision Inputs • ISO/IEC Directives, Part 2 Rules

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ISO 9001:2015 : An Overview of Changes

INLAC Martes 26 de Mayo 2015

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 QualisoCanadian Delegate Expert ISO TC 176 SC2 WG24

LE GROUPE 2750, Rue Einstein, bureau 350Québec (Québec) Canada G1P 4R1 Tel : (418) 650-0675 email : [email protected]

260, Rue Sherbrooke Est, bureau 124Montréal (Québec) Canada H2X 1E1Tel : (514) 286-9693

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

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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

LE GROUPE ISO 9001:2015 : An Overview of Changes

Inlac – Martes 26 de Mayo 2015

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ISO 9001:2008Quality Management System

LE GROUPE

Extract ISO 9001:2008

ISO 9001:2015 : An Overview of Changes


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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 focus2. Leadership3. Engagement of people4. Process approach5. Improvement6. Evidence-based decision making7. Relationship management



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A Change of Organizational Culture



QualityTools

Conformity Customersatisfaction

Performanceimprovement

Organizationalculture gapLeadership

Continuous improvementCustomer satisfaction

P DCA

Considerationof risks

ISO 9001:1987

ISO 9001:2000

ISO 9001:2015

ISO 9004:2009Business

ExcellenceModels

Organization

8LE GROUPE

Extract ISO FDIS 9001:2015ISO 9001:2015 : An Overview of Changes


ISO 9001:2015Quality Management System

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4. Context of the OrganizationWhat’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 : TargetHow 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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Case Example : TargetLessons 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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Case Example : TargetLessons 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. LeadershipWhat’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. LeadershipChallenge:• 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 VodkaA 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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Case Example : PUR VodkaFinally, … 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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Case Example : PUR VodkaFinally, … 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. PlanningWhat’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. PlanningWhat’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

authorities.LE GROUPE ISO 9001:2015 :

An Overview of ChangesInlac – Martes 26 de Mayo 2015

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6. PlanningChallenge:• 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 AerospaceThe 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 Cseriescustomer, 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. SupportWhat’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. SupportWhat’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. SupportChallenge:• 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 PokaWelcome social media

• Alexandre Leclerc, son of executive from Biscuits Leclerc, while doing graduate studies in 2011 at the HultInternational 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 OperationWhat’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 OperationWhat’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 OperationChallenge:• 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 SoleilThe 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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9. Performance evaluation 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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9. Performance evaluation



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 : CrocsLove 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.

40LE GROUPE ISO 9001:2015 :

An Overview of ChangesInlac – Martes 26 de Mayo 2015

Bloomberg Business, 1 April 2015

Case Example : CrocsLove 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.

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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 FavorisTaste 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 Favorishas 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



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LE GROUPE ISO - INLAC€¦ · ISO LE GROUPE ISO 9001:2015 : An Overview of Changes INLAC Martes 26 de Mayo 2015. ... ISO 9001:2015 Revision Inputs • ISO/IEC Directives, Part 2 Rules