ISO/HACCP certification software, ISO/OHSAS/EMS/FMS/ISMS management system certification      

Modules of ISOsystemPlus

1.  Documents 
2.  Correspondence 
3.  Processes 
4.  Trainings 
5.  Audits 
6.  Equipment 
7.  Complaints 
8.  Non-conformities 
9.  Risks (OHSAS/EMS) 
10.  Risks (ISO-MED) 
11.  Risks (ISMS) 
12.  HACCP 

1. Registration of correspondence with assigning of the unique code (incoming/outgoing ID)
2. Application of resolution on a document and monitoring of its fulfilment
3. Classification and quick search of correspondence by any parameter (class, type, chapter, subject, sender, receiver, date, ID, etc.)
4. Automatic notification of stakeholders about necessity to take planned actions in due time
5. System of authorized access of users to records/files of correpsondence
6. "Control of documents" mode - quick filtering/sorting/grouping of documents by any number of parameters.
7. Planning of actions with correspondence, monitoring/follow-up of delayed actions
8. Composing of new files of correspondence by all users using consistent common templates.
9. Work with files of all formats that are supported by Windows.
10. 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 )

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".

1. Module "Trainings" is a specially structured database; each records in the database corresponds one training for an employee of a company
2. 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.
3. Determination of competencies as a basis for designing the training plan.
4. 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").
5. Control of training plan, monitoring of trainings' sessions conducting.
6. Quantitative evaluation of conducted trainings and their effectiveness.
7. 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.
8. Access of users to training database information in accordance with different levels of authorization.
9. "Control of trainings" mode - quick search of necessary record(s), sorting/grouping/filtration of trainings records by required parameters.
10. "One-mouse-click" generating of different reports documenting the training process.
11. 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.

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.

1. Full correspondence of the process of planning and conducting audits/corrective actions to ISO 9001:2008 and 19011:2002 requirements.
2. Determination of audit team and requirements to auditors.
3. Organization of training process of auditors, control over the level of competency of auditors
4. "Audit report" - quick composing audit reports in a consistent format corresponding to ISO 19011:2002 requirements
5. "Action plan" mode - quick composing corrective/preventive action plans in a consistent format corresponding to ISO 19011:2002 requirements).
6. Automatic notification of all involved parties about upcoming audits
7. Automatic distribution of files of relevant documents to involved parties
8. Monitoring of audits conducting and taking planned corrective/preventive actions.
9. Monitoring of effectiveness of corrective/preventive actions fulfilled.
10. Automatic notification of users about overdue audits condicting and fulfilling the actions planned.
11. Access to audit/action plant information in accordance with different pre-defined authorization levels.
12. "Control of audits" mode - grouping/filtering/sorting/quick search of appropriate audit records
13. One-click generating of consistently shaped required documents (audit reports, corrective/preventive action plans, etc.)
14. Automatic transferring the non-conformities found into the "Non-conformities" module for their qualitative analysis

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:

1. Control/plan process of purchasing equipment
2. Monitor financial performance of the purchasing process
3. Automatize control of planned actions with equipment at regular intervals, including periodical ones (calibration, verification, etc.)
4. Automatically inform responsible users about overdue planned action(s)
5. Control location of the equipment within the organization, responsibilities
6. Determine and control responsibilities of persons involved in the process
7. Make up and keep register of suppliers of the organization
8. Control status of suppliers of the organization
9. Work in "Control of equipment" mode - quick searching/filtering/grouping/sorting of equipment by needed parameter(s)
10. Generate needed reports by "one-mouse" click, convert/save the reports in Word or Excel formats

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"Complaints" module

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:

1. Determine an an explicit customer-focused complaints-handling policy of the organization
2. Define responsibilities and authorities of all parties involved in the proces of handling of complaints
3. Establish complaints-handling objectives for relevant functions and levels within the organization and monitor meeting the objectives at regular intervals.
4. Assess the needs for resources for complaints-handling process and monitor their providing at regular intervals.
5. Make up and keep register of customers of the organization.
6. Quantitatively evaluate level of satisfaction of each customer.
7. Track and control the full path of complaints wihtin the organization.
8. Automatize complaints registering process.
9. Define a single responsible person for handling of each complaint.
10. Monitor timeliness of executing of planned actions on each complaint.
11. Ensure continuous and automatic warning of stakeholders if actions planned are overdue.
12. Organize access to complaints-handling process information in accordance with authorization levels.
13. Analyze effectiveness of the complains-handling process.
14. Conduct audit of the complaints-handling process.
15. Work in "Control of complaints" mode - quick searching/filtering/grouping/sorting of complaints records by needed parameter(s)
16. Generate needed reports by "one-mouse" click, convert/save the reports in Word or Excel formats

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"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:

1. Develop a system for classification of nonconformities
2. Define criteria of their quantitative evaluation.
3. Organize registration of non-conformities and effective control over their in-time elimination
4. Carry out comparative quantitative analysis of nonconformities (number, "seriosity", reason, area of occurring, responsible for elimination, etc.) .
5. Carry out quantitative evaluation of effectiveness of your organization's management system.
6. Work in "Control of complaints" mode - quick searching/filtering/grouping/sorting of complaints records by needed parameter(s)
7. 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
8. Work in "Control of non-conformities" mode - quick searching/filtering/grouping/sorting of non-conformities records by needed parameter(s)
9. Generate needed reports by "one-mouse" click, convert/save the reports in Word or Excel formats

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"Risks-OHSAS/EMS" module


Configuration "OHSAS/EMS" will assist you in developing the Risk Management System in accordance with requirements of standards OHSAS 18001:1999 and/or BS OHSAS 18001:2007 (Occupational Health and Safety Assurance System) or ISO 14001:2004 (Environmental Management System).

Below just several of tasks which you could fulfill using "ISOsystemPlus"' capabilities:

1. To define and authorize the organization’s OH&S/EMS policy
2. To develop a methodology for hazard identification, risk assessment and determining controls
3. To determine roles and responsibilities of all stakeholders of your company's OH&SMS/EMS, to deliver this information to all interested parties
4. To plan and control allocation of resources needed for proper functioning of your company's OH&SMS/EMS
5. To plan goals and targets of your company's OH&S management system and monitor their achieving in planned time
6. To take into account and implement legal and other requirements applicable to the organization's OH&SMS/EMS
7. To make up comprehensive list of objects of OH&S system
8. To conduct effective identification of hazards for each OH&SMS/EMS object
9. To evaluate and asses risk associated with each hazard identified
10. To determine control measures to minimise risks to acceptable level
11. To verify implementation of control measures as planned, as well as to verify the effectivness of the implemented control measures
12. And many, many other useful features which you could evaluate if decide to get familiarized with the program.

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"HACCP" module

What is "HACCP"? HACCP is the initials that stand for Hazard Analysis and Critical Control Point - this is, generally speaking, a "state of the art" systematic, science-based approach to Food Safety, that is used in food industry as a means to assure food safety. It helps preventing food contamination by identifying potentially unsafe links in the food processing chain, "from farm to fork", targeting elimination (or minimization to an acceptable level) possibilities of delivering the unsafe food products to final consumer.

Ideology and methodology of the "HACCP" module completely meets requirements to HACCP system described in the "Guidelines for HACCP SYSTEM Application" (ALINORM 93/13A, Exhibit II) of Codex Alimentarius Commission, EC Council Directive 93/43 dated 14 June 1993 on Foodstuffs Hygiene, "Requirements for a HACCP Based Food Safety System", compiled by the National Board of Experts - HACCP, the Netherlands (3rd Version, Sep-2002), ISO 22000:2005 Standard. The module "HACCP" (together with some other software modules) will help you to develop Food Safety Management System or integrated Food Safety and Quality Management System in accordance with requirements of ISO 15061:2002 and/or ISO 22000:2005

1. "HACCP" module is an hierarchically database that is filled out with records of hazards.
2. Consequence of filling in the database forms/tables - "Management Responsibility", "Product Description", "Process flow construction", "Process flow validation", "Hazard analysis", "CCP determination", "CCP monitoring and control", "Corrective actions", "Verification", "Validation", "Documents/records management" - completely meets requirements of the Guidelines for HACCP System Application (ALINORM 93/13A, Exhibit II) of Codex Alimentarius Commission, with EC Council Directive 93/43 dated 14 June 1993 on Foodstuffs Hygiene, "Requirements for a HACCP Based Food Safety System", compiled by the National Board of Experts - HACCP, the Netherlands (3^rd Version, Sep-2002), ISO 22000:2005 Standard.
3. Modules "Documents", "Trainings" and "Audits" help users in setting up effective systems of documents/records management, personnel training and internal audit/verification systems as parts of the comprehensive Food Safety Management system.
4. "Self-learning" database of the software accumulates all pieces of information and optimizes/facilitates users' efforts to develop HACCP plans for new products and processes.
5. Flow-chart builder will help users to draw up a flow-chart of food chain processes with necessary degree of detalization.
6. Mode "Control of hazards" - a tool for quick search/sorting/filtering of required record(s) of hazards by their core features (type, source, product, process, significance, etc.).
7. "One click" approach to documenting the HACCP system - ISOsystemPlus provides users with the unique system of generating numerous documents-reports (including such HACCP-required reports as "Product description", "Hazard analysis", "Decision tree - CCP determination", "CP/CCP listing", "CCP monitoring and control", "HACCP plan", "System verification/validation report", etc. All generated reports can be saved either as hard copies or converted into files of -.doc or -.xls format and saved in electronic form as food management system documents/records.
8. "Easy-to-learn", user-friendly interface of the software, with the consistent methodological approach of all its modules
9. The best "quality:price" ratio among relevant competitive products.

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"Risks-ISOMED" module

The "Risks - ISO-MED" module is intended for companies which develop Quality and Risk Management System applicable to medical devices (standards ISO 13485:2003 and ISO 14971:2007). The module is, basically, the Risk Management File in terms of Ch. 3.6 of ISO standards 14971:2007. It will assist in setting up the Risk Management System - i.e.:

1. Defining the scope and boundaries of your Quality/Risk Management System
2. Planning responsibilities of all stakeholders
3. Determining goals of the management system and monitoring their achieving
4. Defining resources needed for functioning the management system and monitoring their allocation
5. Designing risk assessment approach of an organization
6. Determining objects of risk analysis - medical devices, and their lifecycle stages
7. Identifying hazards for each object at a particular lifecycle stage
8. Identifying consequence of events that might lead to a hazardous situaiton
9. Identifying harms potentially caused by the hazardous situations
10. Evaluation and assessment of risks assosiated with each hazardous situation/harm indetified
11. Planning risk control measures needed to reduce the risk to acceptable levels
12. Verification of implementation and effectiveness of the control measures planned
13. Conducting "Risk-Benefit" analysis and determining the residual risk acceptability
14. Designing Risk Management Plan

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"Risks-ISMS" module

Configuration "ISMS" is customized to help an organization to develop Information Security and Risk Management System in accordance with ISO 27001:2005 requirements.

Below you can find out just several tasks which you could fulfill using ISOsystemPlus software:

1. Defining the scope and boundaries of ISMS
2. Defining the responsibilities of all ISMS stakeholders
3. Defining goals for ISMS, monitoring their achieving
4. Defining resources needed for functioning ISMS, monitoring their allocation
5. Defining the risk assessment approach of an organization
6. Determination of IT objects (assests)
7. Identification and assessment of threats and vulnerabilities
8. Identification of risks
9. Evaluation and assessment of risks
10. Identification and evaluation of risk control objectives and measures
11. "Risk-Benefit" analysis, analysis of residual risk acceptability
12. Preparing Statement of Applicability
13. And many, many other useful features which you could evaluate if decide to get familiarized with the program

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