Management de la Qualité - Customer Needs & ISO 9001

• Management de la Qualité is presented by Soumaya BEN AICHA
• This module covers customer needs and quality, quality management principles, key changes in the 2015 version of ISO 9001, ISO 9001:2015 requirements, and the implementation and benefits of a quality management system (QMS)

La Qualité - ISO 9000:2015 Definition

• Quality is defined as the aptitude of a set of intrinsic characteristics of an object to satisfy requirements
• Therefore characteristics must then conform to the needs and requirements

Evolution des besoins clients

• There has been an evolution of customer needs
• Customers focus on quantity, intrinsic product quality, integrated quality, and trust in the supplier's quality system
• The focus for businesses has evolved from Taylor's methods, to quality control (sampling, measuring, deciding), mastering quality (controlling, analyzing, remedying), and quality assurance

Assurance Qualité

• According to the ISO 9000:2015 definition, it is the part of quality management aimed at giving confidence through conformity to quality requirements

Assurance Qualité Context

• Quality of the organization is a means to ensure the quality of products and services
• Quality assurance focuses on the quality of products and services

Évolution des besoins clients cont.

• The evolution of customer needs includes quantity, intrinsic product quality, integrated quality, trusting the supplier's quality system, and imposing a quality system on the supplier

Imposer un Système Qualité au Fournisseur

• Companies may impose a quality system on their suppliers

Historique de la qualité

• Historically quality has changed from craftmanship in the 1950s, to quality control in the 1970s to quality management in the 1990s

Management de la Qualité

• This refers to coordinated activities to direct and control an organization regarding quality

• It generally includes establishing a quality policy, setting quality objectives, and implementing processes

• Additional components are; quality planning, quality control, quality assurance, and quality improvement

• Management de la Qualité also includes guaranteeing quality, proving it, recording it, and improving it

Système de Management de la Qualité

• The ISO 9000:2015 definition is a part of a management system related to quality
• The objectives are to produce conformity to customer and regulatory requirements; and increase customer satisfaction through system efficiency and continuous improvement

Les normes ISO de management de la qualité

• ISO 9000:2015 focuses on vocabulary, ISO 9001:2015 focuses on requirements, and ISO 9004:2018 includes recommendations
• Certification is obtained only under the ISO 9001 standard

Les principes de management de la qualité - ISO 9001 Evolution

• The principles of quality management continue to evolve, and include;
• Orientation client
• Leadership
• Personnel Involvement
• Process approach
• Improvement
• Factual decision-making
• Mutually beneficial relationships with suppliers

Les principes de management de la qualité - ISO 9001:2015 Evolution

• The principles of quality management were updated to include;
• Orientation client
• Leadership
• Personnel Involvement
• Process approach
• Improvement
• Evidence-based decision making
• Relationship management with interested parties
• Sam Walton said there is only one boss in his company: the customer

1-Orientation Client

• Sustainable performances come when an organization gains and maintains the trust of customers and other relevant parties
• Every aspect of interaction gives customers an opportunity to create more value for the customer
• Understanding clients existing needs and future needs contributes to the long term performance of the organization

1-Engagement Client

• Customer orientation throughout the organization limits the risks of dissatisfaction

2-Leadership

• Leadership is defined as the art of getting someone else to do something
• Employees at all levels need proper direction, orientations, resources and a supportive environment

3-Implication du personnel

• A skilled, empowered, and engaged staff is needed for creating a stronger corporate culture
• Facilitate open discussions, knowledge sharing, internal communications, and collaboration

4-Approche processus

• Coherent and predictable results are obtained more efficiently, and effectively, when activities are understood and managed as correlated processes that function as a coherent system

5-Amélioration

• Improvement is essential for an organization to maintain its current performance levels, respond to changes, and create new opportunities

• Encouraging goals of improvement, ensuring competent staff to have the projects be successful, and applying processes to have the projects being done in a structured manner

6-Prise de décision fondée sur des preuves

• Fact-based decisions are more likely to produce the desired results
• One needs to Identify key indicators, ensure data availability, ensure data reliability, and apply an analysis

7-Management des relations avec les parties intéressées

• Durable performance is more likely when relationships are managed wth outside parties for impact on the corporation as a whole

Les principes de management de la qualité : version 2015

• The principals of management have been refined to include;
• Customer orientation
• Management responsibility
• Staffing
• Process Approach
• Remediation
• Evidence based decision making
• Engagement with stakeholders

Le planning de la révision ISO 9001

• The schedule for the revision of IS 9001 is displayed
• Publication of the new ISO norm was in Sept 2015

ISO 9001 : Evolution

• Historical milestones are listed in the evolution of ISO 9000 and then ISO 9001
• From creation of CT 176 in 1979 then to publication of ISO 9000 in 1987
• Revisions where in 1994, 2000, 2008 and 2015

Principales évolutions : ISO 9001

• Highlights the need for high level structure (HLS), organizational reflection, analysis of associated risks and greater focus on the role management
• Also focus needs to be on management of documentation in favor of documenting the data

Principales évolutions : ISO 9001 cont.

• The focus needs to be on:
• Confirmation of the process approach.
• Emphasis on skills and knowledge management
• Consistency in the control of products and services provided by external providers
• A need to emphasize the 'service' in addition to the term product
• importance of change management
• The notions of results, improvement and effectiveness.

Exigences ISO 9001

• Standards must be integrated and easy to implement
• They cover things like scope, normative references, terms, context, leadership and planning, then goes further with;
• Support implementation, operational activity evaluation of performance and continued improvement

4 Contexte de l'organisme

• Firms then need to determine significant external issues
• These issues can have positive or negative factors
• Examples include; a new competitor, evolving regulations, cultural events, political changes etc.

4 Contexte de l'organisme cont.

• The organization needs to also;
• Determine the interested parties relevant to the company
• Assess the requirements of the impacted parties and their importance to the context of the management system

4 Contexte de l'organisme cont.

• These considerations depend on real or potential impacts
• Determine the fitness of the fitm to deliver the expected products
• Examples of impacted parties are:
  • Clients
  • State agencies
  • Banks or other financials
  • collaborators'

4 Contexte de l'organisme Quelques vecteurs de compétitivité

• Important considerations depend on maintaining competitiveness

4.3 Détermination du domaine d'application du SMQ

• The organization needs to determine limits and applicability of the QMS
• It must also account for external internal issues, the requirements of impacted parties and the products of the company

4.4 Système de management de la qualité et ses processus

• The organization has to establish, implement and continuiously improve a QMS in relation to neccessary processes and interactions

Approche Processus

• A process (ISO 9000 : 2015) : all correlated activities that will use entry elements to produce a certain result

There are several key questions that firms can answer regarding the approach

• Risk or opportunities ?
• What actions ?
• What skill sets ?
• What will entry elements look like ?
• How will methods operate ?
• How many performance indicators are needed

Cartographie des processus : exemples

• Mapping of the processes

4 Contexte de l'organisme The need to determine steps

• Practical exercise in 3 steps
• Determining the processes of the organization
• Determination of the interactions between processes
• Developing a process form

5 Leadership 5.1.1 General principles

• The directives the direction must maintain are the overall responsibilities of the SMQ

5.1.2 Orientation client principles

• Firms need to determine, understand and sustain the customers requirements

5.2.1 Etablissement de la politique qualité

• The direction must maintain a focus on finality and organizational focus

5.3 roles, responsabilités et autorité au sein de l'organisme

• The direction must maintain a strong focus
• There should be;

1. Conformity to the standards
2. An accountability for process delivery
3. Promotion of client focus by people at all levels

6 Planification - principles of planning

• Maintain plans to face risks and opportunities effectively
• Actions taken must be proprotional

6 Planification - the risks

• Risk means there is a lack of information, for example a bad understanding of an event from external source
• There needs to be a good balance when assessing any potential reward

Definition of an unwanted event

• It is the cross multiplication of probability vs potential event effect

Attention during this risk planning process

• The goals and considerations as part of SMQ should always be used as the goal and tool for prevention
• There must be considerations for formal risk documentation

L'un des principes de management

• Proactivity is generally more desirable the reactivity

6 Planification - general things

• 1 Determine risks and opportunities
• 2 Linkages with processes

6 Planification - the goals for the entity

• These can be related to quality
• They then should be coherent and measurable based on any specific client base

6 Planification - cont.

• Additional key points; must have a link to resources allocated
• They need to meet the customer where they live (be available for contact)

The planning and modification procedures

• They must have to; be clearly objective and provide sufficient resources for quality delivery

7 Suport - General concepts

• Are we providing the direction to identify and deliver resources to all processes ?

• Considerations must take both existing internal anad any need to bring in outside services to supplement any shortfall

7.1.2 Ressources humaines - General concepts

• the goal of staff being to provide useful data

7.1.3 Infrastructure - General concepts

• the goal of the team is to determine then maintain required infrastructure

7.1.5 Ressources pour la surveillance et la mesure

• the focus is on supplying measuring and tracking data

7.1.6 Connaissances organisationnelles

• the goal is to make the staff competent

The focus should be on ; providing appropriate training and an onjective outlook

7.3 Sensibilisation

• there needs to be an awareness for the entire organization

7.4 Communication

• this involves having a documented communications policy

7.5 Informations documentées

• it is essential to keep different documents

8 Réalisation des activités opérationnelles

• Process management flow is essential in quality maintenance

9 Évaluation des performances

• it involves an analysis, the methods, and validity of the evaluation

the steps involve: a) meeting of client objectives b) levels

9.1.3 Analyse et évaluation

• The organization may analyse and evalute the performance of QMS and process management by :

1. measuring client satisfaction
2. level setting
3. by following proper guidelines

Audit - general concept

• The audit must be : a) methodically independent b) used to obtain objective data

10 Amelioration - General concept

• Improvements must be sustainable while still meeting all customer standards