G 22 IZOGOOD 13485 - Decrypt the MD standard ISO 13485 while having fun - Online game
Online game IZOGOODŽ 13485 - Decrypt, understand and assimilate the requirements of your medical devices quality management system ISO 13485 while having fun
$79.28
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See the online course T 22v16 ISO 13485 Readiness See the online course T 42v16 ISO 13485 Internal audit See the online training package T 82v16 ISO 13485 |
WHY NOT ENRICH YOUR KNOWLEDGE OF THE ISO 13485 STANDARD WHILE HAVING FUN?
THE GAME
- anyone who wants to discover the ISO 13485 standard
- anyone who wants to improve their knowledge of the ISO 13485 standard
- threats or opportunities by the 50 RISK cards
- requirements of the standard by the 50 MCT (multiple choice test) cards
- good or bad practices by the 50 PRACTICE cards
- case examples by the 50 CASE cards
- the assimilation of knowledge related to the ISO 13485 standard
- a more homogeneous understanding of:
- content
- specificities and
- requirements of the ISO 13485 standard
- verification of achievements
- playful learning of the standard
- better prepare for certification or follow-up audit
CONDITIONS
Read more
Anyone involved in introducing, implementing, maintaining, consulting, training and improving a medical devices quality management system based on ISO 13485:
- leader of the ISO 13485 certification project
- director
- quality manager
- metrology manager
- maintenance manager
- project Manager
- quality technician
- quality assistant
- quality operator
- quality manager
- internal auditor
- worker
- operator
- technician
- medical devices consultant
- trainer
- adviser
- student
GAMER’S BOOKLET
Table of contents
1. Rules of the game
2. Glossary
3. Cards
1. RULES OF THE GAME
- RISK - threat or opportunity - silver
- MCT - multiple choice test - green
- PRACTICE - good or bad practice - orange
- CASE – situation, challenge and solutions - blue
- 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
- 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?
- number of stars earned
- date and time each time you played
- time spent
- 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
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
Threat |
§ 4.2 |
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)
Threat |
§ 4.1 |
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)
Threat |
§ 4.1 |
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