GAMER’S BOOKLET
Table of contents
1. Rules of the game
2. Glossary
3. Cards
1. RULES OF THE GAME
The game is intended for one person, but nothing prevents playing in a small group, it will be much more fun.
The game is compatible with recent versions of web browsers. Otherwise the game can be slow.
A game session typically lasts between half an hour to 2 – 3 hours. You can play as many times as you like during your 60-day access and learn a lot about the ISO 13485 standard.
The goal of the game is to reach the final space (Finish) as quickly as possible.
The standard's requirements and comments are on this
page. A free quiz on the ISO 13485 requirements is provided at the beginning. This allows you to discover, decrypt and become familiar with the requirements of the standard.
Having a copy of the ISO 13485 standard at hand (not supplied with the game) is a prerequisite.
The board of the game is a city with a car's journey.
In the top left, there is a clock showing elapsed time. In the top right, you have a help button and option to exit the game.
At the bottom left, there's a button to mute the sound. In the bottom enter, you can see the total stars you've earned.
At the bottom right, there's a button linkng to the ISO 13485 standard requirements page.
At the beginning, the car is parked at the Start space.
Click on the "START GAME" button to begin.
The sequence of spaces (types of cards) is as follows:
- RISK - threat or opportunity - silver
- MCT - multiple choice test - green
- PRACTICE - good or bad practice - orange
- CASE – situation, challenge and solutions - blue
You also have special Maintenance
and Padora’s box spaces
.
Each card type includes 50 questions, and each answer is linked to a paragraph of the ISO 13485 standard version 2016.
Each card is shown with the following steps:
- step 1: The back of the card showing the card type, number (from 1 to 50) and the number of stars (from one to three) in blue, white and red , ,
- step 2: The card type, its number, the question (e.g., "Is the following statement more of a threat or an opportunity?"), the statement (e.g., "The scope of the QMS describes the main company's activities") and the star(s)
- step 3: The answers (one or more correct answers are possible) with a green emoji (for all correct answers) and a red emoji (for a wrong answer)
- step 4: The paragraph from the standard and a comment for the correct answer or incorrect answer
The car starts and arrives at the Risk space.
The card number is random. Depending on the question's difficulty, the stars are one, two or three.
If you guess the correct answer, the car moves forward as many spaces as there are stars on the question.
If you don't guess the correct answer (or answered partially) the car stalls on the same space, and the next card will be of the same type.
If you land on a Maintenance
or a Pandora's box space
, you may get lucky or unlucky. From the car's trunk or Pandora's box comes a random luck or misfortune card. If luck is on your side, you get Joker card
, and your car moves forward 3 spaces. If misfortune strikes
, your car moves back 3 spaces.
If a second person is with you and has printed this booklet, they can increase the game's difficulty by asking questions like:
- What is the clause and sub-clause (paragraph) of the standard related to the question?
- Can you provide an example from your department related to this question?
When you reach the Finish space for the first time, you can download your IZOGOOD® 13485 game participation Certificate.
You can also view your game results:
- number of stars earned
- date and time each time you played
- time spent
The educational objectives of the game are to allow each player to:
- identify whether a risk is more of a threat or an opportunity
- enhance their knowledge of the standard's requirements through multiple choice tests (MCTs)
- guess whether a statement is a good or a bad practice
- study each proposed case's situation, challenge, and to find the right solution (one or more correct solutions are possible)
- decrypt the clauses and paragraphs of the standard and to assimilate the requirements
Some questions have a hint of humor (even if the boss forgot to say it).
Relax, it's just a game.
A bias is inevitable regarding the “correct answers” to retain, especially for RISK or PRACTICE cards.
Here's an example:
RISK 01. Is the following statement more of a threat or an opportunity? "The most important thing is that the company's strategy was established in the past"
One could answer that it is a threat or an opportunity but it depends on when the strategy was defined.
If you answer that it is a threat, you're right because it's not specified when the previous strategy was developed (a year ago, 10 years ago). There's missing information. But you could answer that it's an opportunity because you think "in the past" means 2 to 3 years ago.
Thus, the presented answers and the relevance of the comments presented are debatable; in the end, the truth is sometimes relative.
The IZOGOOD games are created and developed with great care. Thank you in advance for communicating any potential improvement points you've identified via this
link: https://www.pqbweb.eu/contact.php
2. Glossary
The beginning of wisdom is the definition of terms. Socrates
Some 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
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
Document: 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
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
Stakeholder: person, group or company affected by the impacts of an organization
SWOT: Strengths, Weaknesses, Opportunities, Threats. Tool for structuring a risk analysis
Top management: group or persons in charge of the company’s control at the highest level
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 and ISO 13485 definitions is recommended. The most important thing is to determine a common and unequivocal vocabulary for everyone in the company.
Remark 2: a document can be presented as documented information that must be maintained (procedure ) or retained (record ).
3. CARDS
Examples of the first 3 cards
RISKS
Recurring question: Is the following statement more of a threat or an opportunity?
RISK 01 The most important is that the organization's strategy was established in the past
Every three years on average, it's advisable to verify the strategy's adequacy with the company's context and the expectations and needs of stakeholders. It's a threat because the date when the strategy was developed isn't specified
RISK 02 QMS processes are efficient, i.e. carried out with minimum effort (even when the boss isn't around)
By implementing the necessary actions to achieve the planned results, see § 4.1.3
RISK 03 In-house promotion of process mapping (because the boss said to manage on our own)
This is an opportunity to let everyone know about process mapping. This allows everyone to situate themselves in the overall operation of the organization and in supplier customer relationships with other processes
MCT'S (MULTIPLE CHOICE TESTS)
MCT 01 Only one of the following statements is correct. Can you name which one?
- A product can be certified ISO 13485
- A service can be certified ISO 13485
- The management system of an organization can be certified ISO 13485
- Any organization with more than 100 people shall be ISO 13485 certified
§ 0.1
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 13485. Certification is voluntary for any organization, whatever the size
MCT 02 In the 7 principles of quality management (even if the boss has no opinion), we can find:
- Quality approach
- Engagement of people
- Quality policy
- Risk approach
§ 0.2
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 approach enters into ISO 13485 version 2016 but not in the 7 principles of quality management
MCT 03 In the Deming cycle, the A stands for:
1. Analyze
2.Act
3. Improve
4. Adopt
§ 0.3
In the DEMING cycle, the data analysis is in the C (Check)
PRACTICES
Recurring question: Is the following statement more a good or a bad practice?
PRACTICE 01 The diagnosis of the organization context includes the main external and internal issues (even if the boss doesn't know about it)
To understand the context of the organization, top management must prioritize internal and external issues
PRACTICE 02 To determine the issues of the context, the analysis of the competitive environment is a priority
Top management must first determine internal and external issues
PRACTICE 03 The analysis of the needs and expectations of interested parties is independent of the products and services of the organization
The organization's products and services must take into account the needs and expectations of interested parties
CASES
CASE 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:
Solution 1: regularly monitor and review issues
Solution 2: determine the positive or negative influence of each issue
Solution 3: use SWOT and PEST tools
§ 4.1
All these activities are very useful for analyzing the context
CASE 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: stand out from the competition with very low prices
Solution 2: recruit a marketing agent out of a top college
Solution 3: contact the customer and identify the problem
§ 4.2
Setting very low prices is daring but it is not a guarantee of success and can have disastrous financial consequences
A new marketing agent can bring profits but it is time consuming and requires a significant investment
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
CASE 03 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?
Solution 1: justify each non-applicable requirement in a documented information
Solution 2: maintain the scope of the QMS (sites, processes, products and services) as documented information
Solution 3: base the scope of the QMS on the business context, the requirements of interested parties and the products and services provided
§ 4.3
All these activities are useful for determining the scope of the QMS