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G 15 IZOGOOD 9001 - decrypt the quality standard ISO 9001 while having fun

Decrypt, understand and assimilate the requirements of your ISO 9001 quality management system standard while having fun

 
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G 15 IZOGOOD 9001 - decrypt the quality standard ISO 9001 while having fun
  • Added the: 15/11/2018
  • Last update: 04/11/2018
See other games
 

WHY NOT PLAY AT WORK?

 
The game IZOGOOD 9001 allows you to browse the various aspects of the ISO 9001 standard by more or less difficult questions by addressing:
  • threats or opportunities with 50 RISK cards
  • requirements of the standard with 50 MCT cards
  • good or bad practices with 50 PRACTICES cards
  • case studies with 50 CASE STUDIES cards
 
The game leader will provide explanations from his expertise and will find support in the booklet that is proposed.
 
The IZOGOOD 9001 game will help everyone gain a better understanding and sharing of knowledge about the ISO 9001 standard while having fun.
 
The clauses and sub-clauses of the ISO 9001 standard will be more comprehensible and the requirements simpler to assimilate and apply.
 
Whatever the functions of the players, their responsibility and the level of knowledge of the standard, everyone will deepen their understanding of the essential points of the quality management system.
 
The benefits of a game in a business are, among others, to allow:
  • the acquisition of knowledge related to ISO 9001
  • an exchange of different points of view and a more homogeneous collective understanding of:
    • contents
    • specificities and
    • requirements of ISO 9001
  • the verification of acquired learning
  • the playful learning of the standard
  • to be enriched by the skills of others
  • to be better prepared for the certification or the follow-up audit

 

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Any consultant and trainer specialized in the quality management system wishing to diversify in a fun way his training on ISO 9001 version 2015

  izogood 9001

PARTICIPANT'S BOOKLET

TABLE OF CONTENTS

  1. Rules of the game
  2. A reminder of the clauses and sub-clauses of the ISO 9001 version 2015 standard
  3. A glossary of used terms

1. RULES OF THE GAME

  • The game is scheduled for 2 to 5 teams of one or more people, during one or more sessions of 2 to 3 hours.
  • A game leader is essential to lead the game, provide detailed answers or additional information on the requirements of the standard.
  • The game starts with an introduction by the game leader about the specificities of the ISO 9001 standard and the benefits of certification.
  • The requirements of the standard and the comments are available at: https://www.pqbweb.eu/page-iso-9001-2015-requirements-quality-management-systems.php. A free quiz on the requirements of ISO 9001 is provided at the beginning of this web page. This will allow you to discover and become familiar with the requirements of the standard.
  • A copy of the standard is available to all.
  • A reminder of the clauses and sub-clauses of the standard is included in the participant's booklet, cf. chapter 2.
  • Each team receives 2 "joker" (joker) chips. This allows them to ask for help another team when the question is (very) difficult to ask. When the answer given by the other team is correct, both teams advance their figures the number of boxes defined by the level of difficulty (1 to 3 stars star) present on the front of the card.
  • There is only one die roll to start the game, which sets the order of play for each team.
  • Each team rolls the die and memorizes the number obtained (from 1 to 6). If several teams have the same number, they roll the die again to decide between them. The order of play for each team corresponds to the descending order of the numbers obtained (from 6 to 1). The die can then be stored in the bag of figures and in the briefcase.
  • Each team chooses its figure and places it on the box "departure" (departure).
  • The teams position themselves around the table in relation to the sequence of their figure on the board.
  • The first team advances the number of boxes of the number it has obtained by rolling the die. Thus, their figure will be on one of the following box categories:
    • RISKS - threat or opportunity - silver
    • MCT - multiple choice test - green
    • PRACTICES - good practice or bad practice - orange
    • CASE STUDIES - blue
  • The cards are organized from 01 to 50 and the top one is 01 - the cards follow the clauses of the standard. For players with an advanced understanding of the standard, the cards are shuffled, which increases the difficulty of the game.
  • The first team takes the card from the top of the category stack, reads the text on the front and back aloud, and answers the question asked. If the answer is:
    • correct, the team advances its figure according to the number of boxes defined by the level of difficulty (1 to 3 stars star) present on the front of the card; during their next turn, the team will then answer the question of the card corresponding to this box.
    • incorrect, the team stays on the same box; in the next round, they will then answer the question of the next card in the same category.
  • The card is placed below the pile of cards or it is set aside, according to a decision taken collectively at the beginning of the game at the initiative of the game leader.
  • Additional questions are at the discretion of the game leader depending on the level of knowledge of the teams and the speed of the game. These could be questions such as:
    • What is the clause and sub-clause of the standard related to the question asked?
    • Can you give an example from your department related to this topic?
  • In consultation with the players and to taking into account the time allocated to the game, the game leader sets the rule for the end of the game.
  • By default, the team that arrives first on the "Certificate" box (certificate) wins.
  • The members of this team are the first to obtain the certificate of participation (certificate). They can then support the answers of other teams with the agreement of the game leader.
  • The end of the game = normally occurs when all teams have reached the last box, "Certificate".
  • A concluding session allows everyone to express themselves on particular points that require further explanation. The game leader will answer these questions or involve the people who have demonstrated the necessary knowledge.

 

2. A REMINDER OF THE CLAUSES AND SUB-CLAUSES OF THE STANDARD ISO 9001 VERSION 2015

There are 309 requirements in clauses 4 to 10 that correspond to a wording that includes the verb "shall".

1 Scope

2 Normative references

3 Terms and definitions

4 Context of the organization

4.1 The organization and its context
4.2 Needs and expectations of interested parties
4.3 Scope of the QMS
4.4 QMS and its processes

5 Leadership

5.1 Leadership and commitment
5.2 Policy
5.3 Roles, responsibilities and authorities

6 Planning

6.1 Actions to address risks and opportunities
6.2 Quality objectives
6.3 Planning of changes

7 Support

7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information

8 Operation

8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development
8.4 External providers
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs

9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review

10 Improvement

10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement

 

3. GLOSSARY


The beginning of wisdom is calling things by their proper names. Chinese proverb

Specific quality terms:

Audit: a systematic and independent survey to determine whether activities and results comply with pre-established measures and are capable of achieving the objectives
Audit evidence: demonstrably true data related to audit criteria
Competence: personal skills, knowledge and experiences
Concession (after production): written authorization to deliver a nonconforming product
Conformity: fulfillment of a specified requirement
Continual improvement: permanent process allowing the improvement of the global performance of the company
Corrective action: action to eliminate the causes of nonconformity or any other undesirable event and to prevent their recurrence
Customer: anyone who receives a product 
Customer satisfaction: top priority objective of every quality management system related to the satisfaction of customer requirements
Documented information: any support allowing the treatment of information
Effectiveness: capacity to realize planned activities with minimum effort
Efficiency: financial relationship between achieved results and used resources 
External provider (supplier): an entity that provides a product
Indicator: value of a parameter, associated with an objective, allowing the objective measure of its effectiveness
Inspection: the actions of measuring, testing and examining a process, product or material to establish whether requirements are met
Interested party: person, group or company affected by the impacts of an organization
Management review: a periodic survey carried out by top management of the management system for its continual improvement
Management system: set of processes allowing objectives to be achieved
Nonconformity: non-fulfillment of a specified requirement
Organization (company): a structure that satisfies a need 
Performance: measurable and expected results of the management system
PEST: Political, Economic, Sociological, Technological. Analysis to identify the influence of external factors 
Process: activities which transform inputs into outputs 
Process approach: management by the processes to better satisfy customers, improve the effectiveness of all processes and increase the global efficiency
Product (or service): every result of a process or activity
Quality: aptitude to fulfill requirements
Quality management: activities allowing the control of a company with regard to quality
Quality objective: quality related, measurable goal that must be achieved
Requirement: explicit or implicit need or expectation
Review: a survey of a file, product, process so as to verify if pre-set objectives are achieved
Risk: probability of occurrence of a threat or an opportunity 
SWOT: Strengths, Weaknesses, Opportunities, Threats. Tool for structuring a risk analysis 
Top management: group or persons in charge of the company’s control at t Traceability: the aptitude to memorize or restore all or part of a trace of executed functions
Validation: notice that the application of any process, product or material allows expected results to be achieved 
Verification: the periodic inspection survey of compliance of a process, product or material

 

Remark 1: the use of ISO 9000 definitions is recommended. The most important thing is to determine a common and unequivocal vocabulary for everyone in the company.

Remark 2: the customer can also be the user, the beneficiary, the trigger, the ordering party or the consumer.

Remark 3: documented information is any information which we must maintain (procedure ) or retain (record ).

 izogood 9001

GAME LEADER'S BOOKLET

TABLE OF CONTENTS

  1. Rules of the game
  2. Introduction to the standard ISO 9001 version 2015
  3. Risks
  4. MCT
  5. Practices
  6. Case studies
  7. Conclusions
     

1. RULES OF THE GAME

  • The game is scheduled for 2 to 5 teams of one or more people, during one or more sessions of 2 to 3 hours.
  • A game leader is essential to lead the game, provide detailed answers or additional information on the requirements of the standard.
  • The game starts with an introduction by the game leader about the specificities of the ISO 9001 standard and the benefits of certification.
  • The requirements of the standard and the comments are available at: https://www.pqbweb.eu/page-iso-9001-2015-requirements-quality-management-systems.php. A free quiz on the requirements of ISO 9001 is provided at the beginning of this web page. This will allow you to discover and become familiar with the requirements of the standard.
  • A copy of the standard is available to all.
  • A reminder of the clauses and sub-clauses of the standard is included in the participant's booklet, cf. chapter 2.
  • Each team receives 2 "joker" (joker) chips. This allows them to ask for help another team when the question is (very) difficult to ask. When the answer given by the other team is correct, both teams advance their figures the number of boxes defined by the level of difficulty (1 to 3 stars star) present on the front of the card.
  • There is only one die roll to start the game, which sets the order of play for each team.
  • Each team rolls the die and memorizes the number obtained (from 1 to 6). If several teams have the same number, they roll the die again to decide between them. The order of play for each team corresponds to the descending order of the numbers obtained (from 6 to 1). The die can then be stored in the bag of figures and in the briefcase.
  • Each team chooses its figure and places it on the box "departure" (departure).
  • The teams position themselves around the table in relation to the sequence of their figure on the board.
  • The first team advances the number of boxes of the number it has obtained by rolling the die. Thus, their figure will be on one of the following box categories:
    • RISKS - threat or opportunity - silver
    • MCT - multiple choice test - green
    • PRACTICES - good practice or bad practice - orange
    • CASE STUDIES - blue
  • The cards are organized from 01 to 50 and the top one is 01 - the cards follow the clauses of the standard. For players with an advanced understanding of the standard, the cards are shuffled, which increases the difficulty of the game.
  • The first team takes the card from the top of the category stack, reads the text on the front and back aloud, and answers the question asked. If the answer is:
    • correct, the team advances its figure according to the number of boxes defined by the level of difficulty (1 to 3 stars star) present on the front of the card; during their next turn, the team will then answer the question of the card corresponding to this box.
    • incorrect, the team stays on the same box; in the next round, they will then answer the question of the next card in the same category.
  • The card is placed below the pile of cards or it is set aside, according to a decision taken collectively at the beginning of the game at the initiative of the game leader.
  • Additional questions are at the discretion of the game leader depending on the level of knowledge of the teams and the speed of the game. These could be questions such as:
    • What is the clause and sub-clause of the standard related to the question asked?
    • Can you give an example from your department related to this topic?
  • In consultation with the players and to taking into account the time allocated to the game, the game leader sets the rule for the end of the game.
  • By default, the team that arrives first on the "Certificate" box (certificate) wins.
  • The members of this team are the first to obtain the certificate of participation (certificate). They can then support the answers of other teams with the agreement of the game leader.
  • The end of the game = normally occurs when all teams have reached the last box, "Certificate".
  • A concluding session allows everyone to express themselves on particular points that require further explanation. The game leader will answer these questions or involve the people who have demonstrated the necessary knowledge.

 

2. INTRODUCTION TO THE STANDARD ISO 9001 VERSION 2015 

Quality is anything that can be improved. Masaaki Imai

The quality approach is a state of mind that comes from top management as a priority strategic decision and extends to all staff. Top management defines the quality policy, in which the quality objectives are set, which are applicable to all activities. The tool used to achieve the objectives is the quality management system. Prevention is the essential concept of the quality management system.

The standard ISO 9001 version 2015 is based on the 7 principles of quality management:

  • customer focus
  • leadership of top management
  • engagement of people
  • process approach
  • continual improvement
  • evidence-based decision-making
  • partnership relations with interested parties

The ISO 9001 standard is also based on:

  • the PDCA cycle for all processes:
    • Plan
    • Do
    • Check
    • Act
  • risk-based thinking

A risk can have negative impacts (we speak of threats) or positive impacts (we speak of opportunities). Often the risk is assimilated to a hazard and commonly used in the place of threat.

Any risk that could disrupt normal business operations is:

  • determined
  • analyzed
  • evaluated and
  • appropriate actions are taken to prevent or reduce adverse effects

Risk-based thinking allows us to prepare the action to be taken if an outcome of the process does not meet a requirement. In other words, to be ready in case something does not work (well).

The purpose of a quality management system is to increase the satisfaction of customers (both external and internal) by meeting their needs and expectations (compliant products and services) through continual improvement of the effectiveness of the processes.

Quality is almost free when customers are satisfied: they remain loyal to us. It is only when the customer is not fully satisfied that quality becomes very expensive to us: sooner or later, the customer will go to a competitor.

Quality remains long after the price has been forgotten

The benefits of implementing a quality management system are often:

  • an improved image of the organization
  • being one step ahead of the competition
  • enhanced customer satisfaction
  • better economic results
  • increased daily effectiveness
  • staff who are aware, consulted, motivated and proud
  • high level of risk control
  • reduced insurance costs
  • profitable engagement for all
  • best practices are valorized
  • formalization of knowledge
  • process control
  • updated legal obligations

The benefits of certification of a quality management system are often:

  • new customers
  • increased market share
  • an increase in sales
  • better financial performance

More than one and a half million businesses worldwide cannot be wrong!

The internalization of the spirit of the principles and requirements of an ISO standard significantly improves the overall performance of your business, especially when it is not considered as a constraint.

The game leader is invited to ask the following questions:

  • for risk cards:
    • to which clause and sub-clause of the standard are these statements (threats or opportunities) related?
    • can you give an example of threats or opportunities in your department and actions undertaken?
  • for MCT cards:
    • to which clause and sub-clause of the standard are the correct statements related?
    • can you give an example of this statement in your department?
  • for practice cards:
    • to which clause and sub-clause of the standard is this good or bad practice related?
    • can you give an example of this good or bad practice in your department?
  • for case study cards:
    • to which clause and sub-clause of the standard is this case study related?
    • can you give an example of this case study in your department and the actions undertaken?

 

3. RISKS

 

4. MCT

 

5. PRACTICES

 

6. CASE STUDIES

 

7. CONCLUSIONS

 

 

THE FIRST 5 CARDS RISKS, MCT, PRACTICES AND CASE STUDIES

the first 5 cards

 

RISKS (THREATS OR OPPORTUNITIES)

Comments

 
card risk card risk back

01 Most important is that the organization's stratégy has been established in the past

Threat         § 4.1      étoileétoile  
Every three years on average, it is necessary to check the adequacy of the strategy to the context of the organization, the expectations and the requirements of the interested parties
 
02 The context of the organization is something that can be taken into consideration
Threat         § 4.1      étoile   
This is a requirement of the standard and it is unavoidable. This is part of the first work to be done since the validation of the organization's strategy depends on it 
 
03 Seeking to anticipate the evolution of customer expectation is wasted time
Threat         § 4.2      étoile   
The objective of the organization is to satisfy its customers in the long term – to understand the evolution of their expectations is a key factor of success for the future
 
04 Anticipating the evolution of the customer's expectations reduces the risks of a bad determination of the organization's strategy
Opportunity  § 4.2      étoile   
The organization relies on the knowledge of customer expectations to determine its strategy
 
05 We can try to meet legal requirements
Threat          §§ 4.2 ; 5.1 ; 8.2 ; 8.3 ; 8.4 ; 8.5    étoile       
We shall strictly meet legal requirements
 
 

MCT (MULIPLE CHOICE TEST)

Comments

 
MCT multiple choice test card MCT back
 
01 Only one of the following statements is correct. Can you name which one?
    A product can be certified ISO 9001
    A service can be certified ISO 9001
    The management system of an organization can be certified ISO 9001
    TAny organization with more than 100 people shall be ISO 9001 certified
§ 0.1           étoile
A product is certified from a technical point of view according to a reference system, such as CE 023 for a medical device, for example. A service, in the sense of service delivery, cannot be ISO certified. Only the management system of an organization can be certified ISO 9001. Certification is voluntary for any organization, whatever the size
 
02 In the 7 principles of quality management, we can find:
    Quality approach
    Engagement of people
    Quality policy
    Risk-based thinking
§ 0.2           étoileétoile     
The quality approach is a broader concept than a principle. The policy builds on the 7 principles and provides a framework for setting objectives. Risk-based thinking enters into ISO 9001 v 2015 but not in the 7 principles of quality management
 
03 In the Deming cycle, the A stands for:
    Analyze date
    Act
    Bring support
    Adapt
§ 0.3           étoileétoile     
In the DEMING cycle, the data analysis is in the C (Check), the support is in the D (Do); Act or Adapt corresponds to step A
 
04 What does the srandard ISO 9001 determines for a quality management system:
    The requirements
    The fundamentals
    The guidelines for auditing
    The requirements for the automotive industry
§ 0.4           étoileétoile  
The fundamentals and vocabulary are described in ISO 9000; the guidelines for auditing management systems are in ISO 19011. IATF 16949 defines the requirements for quality management systems applicable to production and service part organizations in the automotive industry
 
05 Understand the context of the organization is mainly to:
    Implement actions to address threats and opportunities
    Take into account the strategic direction of the organization
    Determine external issues
    Determiner internal issues
    Review issues periodically
§ 4.1           étoileétoile    
Implement actions to address risks is an effect following the understanding of the context, cf. § 6.1. Take into account the strategic direction, determine and analyze the issues are the appropriate actions
 
 

PRACTICES (GOOD AND BAD PRACTICES)

Comments

 
Good or bad practices card practice back
 
01 The diagnosis of the organization context includes the main external and internal issues
Good practice         § 4.1      étoile    
To understand its context, top management must prioritize internal and external issues
 
02 To determine the issues of the context, the analysis of the competitive environment is a priority
Bad practice            § 4.1       étoileétoile   
Top management must first determine internal and external issues
 
03 The analysis of the needs and expectations of interested parties is independent of the products and services of the organization
Bad practice            § 4.2       étoileétoile 
On the contrary, the organization's products and services must take into account the needs and expectations of interested parties
 
04 Requirements of a customer are taken into account without formal commitment to meet them
Bad practice            § 4.3       étoile 
It is vital to commit to meeting customer requirements. If this is not possible, an in-depth exchange with each party is necessary to identify the alternatives and define an acceptable compromise
 
05 The scope of the organization is relevant and available on request     
Good practice         § 4.3       étoile   
The scope of the quality management system is integrated into the certificate of conformity to the standard established by the certification body. The certificate is also often available on the website
 
 

CASE STUDIES

 Comments
 
card case study card case study back
 
01 Context
Situation: external and internal issues influence the strategic direction and the overall performance of the organization
Challenge: how can we understand the influence of external and internal issues?
To understand the context of the organization, we must:
  1. Regularly monitor and review issues
  2. Determine the positive or negative influence of each issue
  3. Obtain updated information on issues from interested parties
  4. Use SWOT and PEST tools
  5. All solutions (1 to 4) together
§ 4.1          étoileétoileétoile
Issues can have a positive or negative impact on the QMS, the conformity of the products and services and the satisfaction of interested parties. The SWOT and PEST tools are very useful for analyzing the context
 
02 Customers and needs
Situation: for some months the organization has had stagnating sales. Nonconformities have begun to fill the prison
Challenge: what solution should be chosen to reverse the situation?
Solution 1: achieve a technological breakthrough with a new line of products
Solution 2: stand out from the competition with very low prices
Solution 3: recruit a marketing agent out of a top college
Solution 4: contact the customer and identify the problem
§ 4.2          étoileétoile 
1: a technological breakthrough is valid in the long term and requires a significant investment
2: setting very low prices is daring but it is not a guarantee of success and can have disastrous financial consequences
3: a new marketing agent can bring profits but it is time consuming and requires a significant investment
4: find the causes of the intolerable amount of nonconformities and quickly set up a plan of action. Then, openly discuss it with customers, as understanding their needs and expectations is a prerequisite for the recovery of the organization
 
03 Interested parties
Situation: after a discussion in which everyone had a say a consensus emerged on interested parties
Challenge: which is the most relevant list?
Liste A: customers, employees, consumers, shareholders, investors
Liste B: employees, customers, consumers, shareholders, investors
Liste C: shreholders, external providers, customers, employees, investors
§ 4.2          étoile
It is not by chance that Vineet Nayar’s book is entitled "Employees First, Customers Second"
List A: customers are important, but before looking for a customer and trying to satisfy its needs, you must produce something!
List B: the staff is the most important interested party. Before looking for a customer you must produce something!
List C: shareholders are important but before distributing dividends to shareholders you must produce something and then look for customers!
 
04 Scope of the QMS
Situation: we need to maintain the scope of the QMS in the form of documented information
Challenge: what must we do to determine the scope of the QMS?
1. Justify each non-applicable requirement in a documented information 
2. Maintain the scope of the QMS (sites, processes, products and services) as documented information 
3. Base the scope of the QMS on the business context, the requirements of interested parties and the products and services provided
4. All solutions (1 to 3) together
§ 4.3          étoileétoile
The scope of the QMS is to describe the context of the organization, the products and services, the applicable requirements, to justify those that are not, and to keep all these elements as documented information
 
05 Process review
Situation: the process owner regularly conducts a process review. For a successful meeting the owner uses an agenda
Challenge: which solution is the most relevant?
A. Note the differences between the results achieved and the planned results, check whether the requirements of the customers have been evaluated, identify and analyze the nonconformities, evaluate the risks, seize the opportunities for improvement
B. Review the decisions of the previous review. Validate the process sheet. Analyze the indicators. Examine the proposed suggestions. Check availability of resources
C. Analyze the evolution of the purpose of the process, comment on the results of the process audit, examine the sequence and interactions with other processes
D.   All solutions A, B and C together
§ 4.4           étoile       
All the actions planned in the 3 solutions are to be carried out during the process review