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Modules du logiciel
"ISOsystemPlus" est composé de plusieurs modules qui s'occupent de divers aspects des systèmes de gestion;
vous pouvez sélectionner n'importe quel nombre de modules et acheter uniquement ceux dont votre entreprise
a réellement besoin.
- Documents
- Correspondence
- Processus
- Formations
- Audits
- Équipement
- Plaintes
- Non-conformités
- Dangers (OHSAS/EMS)
- Riesqos (ISO-MED)
- Menaces(SMSI)
- HACCP
Establishment of an effective document control system is a basic requirement for a management system
addressing requirements of any ISO standard. In other words, setting up, implementing and maintaining the
document control & management system is a-must prerequisite for effective Management System.
"ISOSystemPlus" is the tool that will help you to get the prerequisite realized.
It is quite place/time consuming idea to describe all capabilities of ISOsystemPlus realized to help you in organizing effective control of the organization
documents, so we will point out below just some of them:
- Quick adding (registration) of documents in the database.
- Control of documents during the life cycle (creation/approval/issue/distribution)
- Continuous monitoring of documents' status during the life cycle
- Automatic notification of stakeholders about necessity to take planned actions in due time
- Automatic distribution of the updated versions of documents to stakeholders
- System of authorized access of users to documents/files
- System to prove the fact of opening the document's file by users
- Control of hard copies of documents.
- Control of filled records.
- Control of external documents.
- Control of passive (obsolete) versions of documents.
- Filtering/sorting/grouping of documents by any number of the document's parameters.
- Quick search of a needed document record
- Composing of new files of documents using consistently designed templates.
- Work with files of all formats that are supported by Windows.
- One-click generating of more than 20 kinds of reports on document control system, their converting/saving in Word/Excel formats.
- And many, many other useful features which you could evaluate if decide to get familiarized with the program.
Le module "Correspondence"
"Correspondence" module will assist you to establish an effective system of control over "non-system" documents of your organization
- letters, orders, requests, etc., etc.
Below just few of useful features of Correspondence module are listed:
- Registration of correspondence with assigning of the unique code (incoming/outgoing ID)
- Application of resolution on a document and monitoring of its fulfilment
- Classification and quick search of correspondence by any parameter (class, type, chapter, subject, sender, receiver, date, ID, etc.)
- Automatic notification of stakeholders about necessity to take planned actions in due time
- System of authorized access of users to records/files of correpsondence
- "Control of documents" mode - quick filtering/sorting/grouping of documents by any number of parameters.
- Planning of actions with correspondence, monitoring/follow-up of delayed actions
- Composing of new files of correspondence by all users using consistent common templates.
- Work with files of all formats that are supported by Windows.
- And many, many other useful features which you could evaluate if decide to get familiarized with the program
(to get the file-installer of the software just click here )
"Processes" module
ISO standards promote the adoption of a process approach, description of business process and
process-oriented management of the business system when developing, implementing and improving management systems.
To implement the process approach, we have to understand what is needed to meet the requirements and what is the cost & value
of the meeting the requirements for both the company and its customers. In other words, to start implementing a process approach, we need a tool to describe
the processes. The eventual target is to determine those aspects of the processes which the organization resources must
be focused at to reach the continuous improvement of the processes performance.
The part of this approach is identifying, describing and measuring inputs, operations and outputs of the process
we are looking at. Begin asking the question, "What other processes interact with this process?". In other words, what processes
provide input to or receive output from this process? Who are the stakeholders in this process? Customers and suppliers of the
business processes may nor be forgotten. How do our processes impact them?
To help you in applying and adopting the "Process Approach" philosophy "ISOSystemPlus" provides you with the unique, simple and relevant
technique based on IDEF/0 approach of processes description. It will make you capable in quick and comprehensive describing the processes of your organization,
figuring out the critical steps of importance in each process, identifying links between processes, activities, measures and flows of resources
to be planned and managed. Below is just a snapshot of the long list of tasks which "ISOSystemPlus" will help you to fix:
- Define, classify and describe/document business processes within your company, using IDEF/0-based technique (inputs/resources - suppliers,
outputs - customers and their requirements, process operations - responsible, criteria of the processes evaluation, etc.)
- Determine and fix the range and scope of responsibility and authority within the processes.
- Describe links/interactions within a process and between different processes ("output-input" approach).
- Determine multi-level structure of business processes, make up a "hierarchy tree" of the processes
- Determine parameters of effectiveness of business processes and monitor their performance at regular intervals.
- Assess the needs for resources for business processes and monitor their providing at regular intervals.
- Quick documenting of all aspects of business processes.
- Compose flow-charts of business processes using built-up flow-chart editor.
- Work in "Control of processes" mode - quick searching/filtering/grouping/sorting of process records by needed parameter(s)
- Generate needed reports by "one-mouse" click, convert/save the reports in Word or Excel formats
Le module "Formations"
This module will be your assistant in implementing requirements of ch. 6.2 "Human resources" of several ISO standards as well as requirements of ISO 10015:1999 "Quality management. Guidelines for training".
"The organization shall:
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy training needs,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4)".
- Module "Trainings" is a specially structured database; each records in the database corresponds one training for an employee of a company
- When the training record is added to the database the following parameters of the training are being defined: a trainee (department/position), training date (planned and actual), training subject, responsible for training (trainer), mark for the training, date of carrying out the evaluation of training effectiveness, mark for the training effectiveness.
- Determination of competencies as a basis for designing the training plan.
- Training plan is designed based on competencies analysis and taking into account organizational structure of a company - "by departments" and "by positions" for each single employee (realization of the requirement "determination of required competency level for all employees").
- Control of training plan, monitoring of trainings' sessions conducting.
- Quantitative evaluation of conducted trainings and their effectiveness.
- Continuous monitoring of in-time conducting the trainings planned and evaluation of their effectiveness; notification of users about necessity to conduct planned actions and/or overdue events.
- Access of users to training database information in accordance with different levels of authorization.
- "Control of trainings" mode - quick search of necessary record(s), sorting/grouping/filtration of trainings records by required parameters.
- "One-mouse-click" generating of different reports documenting the training process.
- Built-in "self-learning" database with training process data (lists of departments. positions, employees, types and sources of training, etc.) to facilitate/optimize the process of filling the database with new records.
Le module "Audits"
Standard ISO 9001:2008, ch. 8.2 says:
"The organization shall conduct internal audits at planned intervals to determine whether the quality management system:
a) conforms to the planned arrangements (see 7.1) to the requirements of this International Standard and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.
An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work".
Module "Audits" assists the software users in achieving these objectives.
- Full correspondence of the process of planning and conducting audits/corrective actions to ISO 9001:2008 and 19011:2002 requirements.
- Determination of audit team and requirements to auditors.
- Organization of training process of auditors, control over the level of competency of auditors
- "Audit report" - quick composing audit reports in a consistent format corresponding to ISO 19011:2002 requirements
- "Action plan" mode - quick composing corrective/preventive action plans in a consistent format corresponding to ISO 19011:2002 requirements).
- Automatic notification of all involved parties about upcoming audits
- Automatic distribution of files of relevant documents to involved parties
- Monitoring of audits conducting and taking planned corrective/preventive actions.
- Monitoring of effectiveness of corrective/preventive actions fulfilled.
- Automatic notification of users about overdue audits condicting and fulfilling the actions planned.
- Access to audit/action plant information in accordance with different pre-defined authorization levels.
- "Control of audits" mode - grouping/filtering/sorting/quick search of appropriate audit records
- One-click generating of consistently shaped required documents (audit reports, corrective/preventive action plans, etc.)
- Automatic transferring the non-conformities found into the "Non-conformities" module for their qualitative analysis
Le module "Equipment"
This module will assist you in establishing appropriate level of control of equipment of your organization (including monitoring
and measuring equipment). Working with the "Equipment" module the users will be able to:
- Control/plan process of purchasing equipment
- Monitor financial performance of the purchasing process
- Automatize control of planned actions with equipment at regular intervals, including periodical ones (calibration, verification, etc.)
- Automatically inform responsible users about overdue planned action(s)
- Control location of the equipment within the organization, responsibilities
- Determine and control responsibilities of persons involved in the process
- Make up and keep register of suppliers of the organization
- Control status of suppliers of the organization
- Work in "Control of equipment" mode - quick searching/filtering/grouping/sorting of equipment by needed parameter(s)
- Generate needed reports by "one-mouse" click, convert/save the reports in Word or Excel formats
Le module "Plaintes"
This module will be your assistant in implementing requirements of ISO 10002:2004 "Quality management. Customer satisfaction.
Guidelines for complaints handling in organizations" and ISO 9001:2008, Ch. 7.2.3. "Customer feedback".
Working with the "Complaints" module, ISOsystemPlus ussers will be able to:
- Determine an an explicit customer-focused complaints-handling policy of the organization
- Define responsibilities and authorities of all parties involved in the proces of handling of complaints
- Establish complaints-handling objectives for relevant functions and levels within the organization and monitor meeting the objectives at regular intervals.
- Assess the needs for resources for complaints-handling process and monitor their providing at regular intervals.
- Make up and keep register of customers of the organization.
- Quantitatively evaluate level of satisfaction of each customer.
- Track and control the full path of complaints wihtin the organization.
- Automatize complaints registering process.
- Define a single responsible person for handling of each complaint.
- Monitor timeliness of executing of planned actions on each complaint.
- Ensure continuous and automatic warning of stakeholders if actions planned are overdue.
- Organize access to complaints-handling process information in accordance with authorization levels.
- Analyze effectiveness of the complains-handling process.
- Conduct audit of the complaints-handling process.
- Work in "Control of complaints" mode - quick searching/filtering/grouping/sorting of complaints records by needed parameter(s)
- Generate needed reports by "one-mouse" click, convert/save the reports in Word or Excel formats
"Non-conformities" module
Standard 9001:2008, ch. 8.5.1 "Continual improvement" requires: " The organization shall continually improve the effectiveness of
the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data,
corrective and preventive actions and management review".
Ch. 5.6 "Management review" of the Standard says: " Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness" - in other words, effectiveness of the management system should be reviewed/assessed on a regular basis.
Module "Nonconformities" will help you to fulfill these (as well as many other) requirements of ISO standards. In particular, using ISOSystemPlus you could:
- Develop a system for classification of nonconformities
- Define criteria of their quantitative evaluation.
- Organize registration of non-conformities and effective control over their in-time elimination
- Carry out comparative quantitative analysis of nonconformities (number, "seriosity", reason, area of occurring, responsible for elimination, etc.) .
- Carry out quantitative evaluation of effectiveness of your organization's management system.
- Work in "Control of complaints" mode - quick searching/filtering/grouping/sorting of complaints records by needed parameter(s)
- Summarize and present results of the analysis in the vivid (graphics, charts, incl. Pareto charts) form suitable for
needs of management analysis and taking business decisions
- Work in "Control of non-conformities" mode - quick searching/filtering/grouping/sorting of non-conformities records by needed parameter(s)
- Generate needed reports by "one-mouse" click, convert/save the reports in Word or Excel formats
Le module "Risks-OHSAS/EMS"
Le Module "Risques (OHSAS / EMS)" vous aidera à développer un système de gestion des risques
conformément aux exigences des normes OHSAS 18001:1999 et / ou BS OHSAS 18001:2007 (système d'assurance de la santé et de
la sécurité au travail) ou ISO 14001:2004 (Système de gestion environnementale -EMS).
Ci-dessous vous pouvez voir quelques tâches que vous pourriez accomplir en travaillant avec le module "Risques":
- Définir et autoriser la politique de l'OH & S / EMS au sein de l'organisation
- Elaborer une méthodologie pour l'identification des risques, l'évaluation des risques et la détermination des contrôles
- Déterminer les rôles et les responsabilités de toutes les parties prenantes d' OHS / EMS de votre société, de transmettre ces informations à toutes les parties intéressées
- Planifier et contrôler l'affectation des ressources nécessaires pour le bon fonctionnement de votre OH & SMS / EMS au sein de votre entreprise
- Planifier les objectifs de votre système de gestion OH & S au sein de votre entreprise et contrôler leur réalisation dans les délais prévus
- Prendre en compte et mettre en œuvre les exigences juridiques et toutes autres taches applicables à l'OH & SMS / EMS de l'organisation.
- Créer la liste détaillée des objets du système OHS
- Effectuer l'identification efficace des risques pour chaque objet d'OH & SMS / EMS
- Evaluer les risques associés à chaque danger identifié
- Déterminer les mesures de contrôle afin de minimiser les risques à un niveau acceptable
- Vérifier la mise en œuvre des mesures de contrôle selon la planification, ainsi que vérifier l'efficacité des mesures de contrôle mises en œuvre
Le module "HACCP"
Le module "HACCP" est prévu pour vous aider dans la mise en place d'un plan HACCP - soit séparément, soit en tant qu'une partie
d'un système intégré de gestion de la sécurité alimentaire et de la qualité conformément aux exigences de la norme
ISO 22000:2005. Il aborde notamment les tâches suivantes qui sont nécessaires pour répondre aux exigences de cette norme:
- Définir l'engagement de la direction, les domaines d'application liés à la FMS et les responsabilités de ses intervenants, la politique de l'entreprise en matière de FMS.
- Assurer un échange ininterrompue et efficace de l'information.
- Déterminer les membres du groupe de gestion de la sécurité alimentaire, fixant les exigences à son chef et ses membres.
- Organiser l'analyse des FSMS par la direction.
- Établir un système de formation du personnel, le contrôle des compétences et de la qualification du personnel.
- Décrire les matières premières et les produits finis selon les exigences HACCP et ISO 22000:2005.
- Préparer un synoptique de tous les processus de production, de leur validation et de la vérification sur place.
- Identifier les risques pour chaque étape du processus de production.
- Évaluer les risques associés aux aléas identifiés.
- Installer le mode de contrôle des risques afin de maîtriser les risques identifiés.
- Déterminer les mesures de contrôle pour minimiser les risques à des niveaux acceptables.
- Analyser toutes les étapes du processus de production afin de déterminer des points critiques pour leur maîtrise - pour des produits finis et des matières premières.
- Contrôler chaque point critique pour sa maîtrise en utilisant la méthode "Limites Critiques - Contrôle - Mesures de correction - Validation".
- Valider et vérifiez votre FSMS.
Le module "Riesqos/ISOMED"
Le module "Risques - ISO-MED" est destiné aux sociétés qui développent un système de gestion de la qualité et des risques
applicable aux moyens médicaux (normes ISO 13485:2003 et ISO 14971:2007). Le module, en réalité, est un fichier de gestion
des risques selon le chapitre 3.6 de la norme ISO 14971:2009. Il vise l'installation du système de gestion des risques pour les
moyens médicaux - c'est-à-dire:
- La détermination du domaine d'application et les limites de votre système de gestion de la Qualité / des Risques
- La planification des responsabilités de toutes les parties prenantes
- La détermination des objectifs du système de gestion et le contrôle de leur réalisation
- La détermination des ressources nécessaires au fonctionnement du système de gestion et le contrôle de leurs affectations
- L'élaboration d'une approche d'évaluation des risques d'une organisation
- La détermination des sujets soumis à l'analyse des risques - les moyens médicaux et leur cycle de vie
- L'identification des dangers pour chaque objet à un stade particulier de son cycle de vie
- L'identification des conséquences des événements qui pourraient conduire à une situation dangereuse
- L'identification des dommages éventuellement causés par les situations dangereuses
- L'évaluation des risques associés à chaque situation dangereuse / aux dommages identifiés
- La planification des mesures de contrôle des risques nécessaires afin de réduire le risque à des niveaux acceptables
- La vérification de la mise en œuvre et l'efficacité des mesures de contrôle prévues
- L'analyse des "risques-avantages" et la détermination de l'acceptabilité des risques résiduels
- L'élaboration du Plan de Gestion des Risques
Le module "Menaces-SMSI"
Le module "Menaces" est prévu pour vous aider dans l'élaboration d'un système de gestion de la sécurité de
l'information conformément aux exigences ISO 27001:2005. Ci-dessous vous pouvez découvrir juste quelques tâches que
vous pourriez accomplir en travaillant avec le module "Menaces":
- Définir le domaine d'application et les limites d'SMSI
- Définir les responsabilités de toutes les parties prenantes d'SMSI
- Définir les objectifs pour mettre en œuvre SMSI, sous contrôle de leur réalisation
- Définir les ressources nécessaires pour le fonctionnement d'un système SMSI, en contrôlant leurs affectations
- Définir la méthode d'évaluation des risques d'une organisation
- Déterminer les actifs IT
- Identifier et évaluer les menaces et les points de vulnérabilité
- Identifier, évaluer les risques
- Identifier et évaluer les objectifs de contrôle des risques et des mesures
- Faire l'analyse "risques-avantages", analyser l'acceptabilité des risques résiduels
- Préparer son SOA (Etat d'applicabilité) en "un seul clic".
- Et grand nombre d'autres fonctionnalités utiles de l'application que vous pourriez apprécier si vous décidez de vous familiariser avec le programme
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