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

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" () 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 ) 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" ().
• 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 ) 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 () wins.
• The members of this team are the first to obtain the certificate of participation (). 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 ).

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" () 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 ) 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" ().
• 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 ) 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 () wins.
• The members of this team are the first to obtain the certificate of participation (). 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

RISKS (THREATS OR OPPORTUNITIES)

Comments

 

Threat         § 4.1        

Threat         § 4.1         

Threat         § 4.2         

Opportunity  § 4.2         

Threat          §§ 4.2 ; 5.1 ; 8.2 ; 8.3 ; 8.4 ; 8.5           

MCT (MULIPLE CHOICE TEST)

Comments

 

§ 0.1           

§ 0.2                

§ 0.3                

§ 0.4             

§ 4.1               

PRACTICES (GOOD AND BAD PRACTICES)

Comments

 

Good practice         § 4.1          

Bad practice            § 4.1          

Bad practice            § 4.2        

Bad practice            § 4.3        

Good practice         § 4.3          

CASE STUDIES

 

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          

§ 4.2           

§ 4.2          

§ 4.3          

§ 4.4