Software (programa) para la ISO 13485:2003 y ISO 14971:2007 certificación

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Modulo "Riesgos"

Module "Risks" exists in three configurations:

  1. OHSAS/EMS
  2. ISO-MED
  3. ISMS

OHSAS/EMS
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 "ISO-MED"' 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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ISO-MED

The companies which develop Quality and Risk Management System applicable to medical devices (standards ISO 13485:2003 and ISO 14971:2007) - for you we developed ISO-MED version of the software. Please click here to visit the ISO-MED site and get the software installer.

ISMS

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 ISO-MED 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

      14. Get the installer